A Randomized, Double-blinded, Single/Multiple Dosing, Dose Escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BCD101 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Physical Examination Abnormalities (MAD)
研究概览
简要总结
A randomized, double-blinded, single/multiple dosing, dose escalation Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of BCD101 in healthy adult volunteers.
The primary objectives of this study are to determine:
- The safety and tolerability of BCD101 in healthy adult volunteers.
- The pharmacokinetic profile of BCD101 following single and multiple dosing.
A control group is included, and dose cohorts will be compared to assess dose-dependent differences in safety, tolerability, and pharmacokinetics.
Key study activities include:
- Administration of single and multiple escalating doses of BCD101 and placebo under controlled conditions.
- Safety and tolerability assessments, including monitoring for adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and serious adverse drug reactions (SADRs).
- Pharmacokinetic (PK) analysis to evaluate the pharmacokinetic characteristics of the investigational product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria
- •Healthy adult volunteers aged 19 years or older at screening.
- •Body weight ≥ 50.0 kg and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at screening.
- •* BMI (kg/m²) = weight (kg) / {height (m)}²
- •No congenital or chronic medical conditions requiring treatment, and no pathological signs or findings upon medical examination.
- •Clinical laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram (ECG) results at screening indicate suitability for participation based on the characteristics of the investigational medicinal product.
- •Fully understood the detailed explanation of this clinical trial, voluntarily agreed to participate, and provided written informed consent agreeing to comply with study requirements during the trial period.
排除标准
- •History or current clinically significant liver, kidney, neurological, psychiatric, respiratory, endocrine, hematological, neoplastic, genitourinary, cardiovascular, gastrointestinal, or musculoskeletal disorders.
- •Female subjects who are pregnant (urine hCG positive) or breastfeeding.
- •History of hypersensitivity (e.g., anaphylaxis, angioedema) or clinically significant allergic reactions to the active ingredient, excipients of the investigational product, or other medications (e.g., aspirin, penicillin antibiotics, macrolide antibiotics).
- •History of gastrointestinal diseases or surgeries that could affect absorption of the investigational drug (e.g., Crohn's disease, ulcers, acute or chronic pancreatitis), except simple appendectomy or hernia surgery.
- •Clinically significant abnormalities on 12-lead ECG at screening, including:
- •QTc interval > 450 ms (males) or > 470 ms (females)
- •PR interval > 200 ms
- •QRS duration > 120 ms
- •Clinically significant laboratory abnormalities at screening, including:
- •Liver function tests (AST, ALT, ALP, γ-GT, total bilirubin) exceeding twice the upper limit of normal.
- •Serum creatinine outside the reference range or estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m² as calculated by the CKD-EPI formula.
- •History of substance abuse or positive urine drug screening for abuse substances.
- •Vital signs at screening after at least 3 minutes of rest in a seated position meet any of the following:
- •Systolic blood pressure ≤ 90 mmHg or ≥ 150 mmHg
- •Diastolic blood pressure ≤ 60 mmHg or ≥ 100 mmHg
- •Pulse rate ≤ 40 bpm or ≥ 100 bpm
- •Evidence of orthostatic hypotension at screening.
- •Use of enzyme-inducing or inhibiting drugs such as barbiturates within 1 month prior to first dosing.
- •Abnormal diet or consumption of foods that could affect drug absorption, distribution, metabolism, or excretion.
- •Use of prescription or herbal medications that may affect the investigational product's characteristics within 2 weeks prior to first dosing, or over-the-counter drugs or dietary supplements within 10 days prior to first dosing (except when judged by the investigator not to affect the pharmacokinetics of the investigational product).
- •Participation in another clinical trial with investigational drug administration within 6 months prior to first dosing (the end date of participation is calculated as the day after the last dose of the previous trial).
- •Whole blood donation within 2 months prior to first dosing, platelet donation within 1 month prior to first dosing, blood transfusion within 1 month prior to first dosing, or inability to abstain from blood donation from informed consent to PSV.
- •Excessive alcohol consumption (more than 21 units per week; 1 unit = 10 g = 12.5 mL pure alcohol) within 6 months prior to first dosing or inability to abstain from alcohol from informed consent to PSV.
- •Smoking more than 10 cigarettes per day within 3 months prior to first dosing or inability to abstain from smoking from 24 hours prior to first dosing until last blood sampling.
- •Consumption of grapefruit-containing foods within 72 hours prior to first dosing or inability to abstain until PSV.
- •Consumption of caffeine-containing foods or beverages (e.g., coffee, green tea, black tea, carbonated drinks, coffee milk, energy drinks) from 24 hours prior to first dosing until last blood sampling or inability to abstain.
- •Engaging in strenuous exercise exceeding daily activity levels from 48 hours prior to first dosing until PSV or inability to refrain from such exercise.
- •Planning to become pregnant or not using reliable contraception methods (e.g., hormonal contraceptives, intrauterine device, sterilization procedures, barrier methods) for self or partner from informed consent until 90 days after last dose of investigational product.
- •Any other reasons deemed by the investigator to make the subject unsuitable for participation.
研究组 & 干预措施
SAD-3(Placebo group)
2 Participants in the SAD-3(Placebo group) arm received a single oral dose of BCD101-P(3 sachets).
BCD101-P is a placebo liquid formulation identical in appearance and volume to BCD101-2, containing no active ingredient.
This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
干预措施: BCD101 Placebo Liquid Formulation (Drug)
SAD-1(Treatment group)
6 Participants in the SAD-1(Treatment group) arm received a single oral dose of BCD101-1(2 sachets).
BCD101-1 is a low-dose liquid formulation containing 2 g of the active ingredient per 10 g sachet.
This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
干预措施: BCD101 Low Dose Liquid Formulation (Drug)
SAD-2(Treatment group)
6 Participants in the SAD-2(Treatment group) arm received a single oral dose of BCD101-2(2 sachets).
BCD101-2 is a high-dose liquid formulation containing 4 g of the active ingredient per 10 g sachet.
This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
干预措施: BCD101 High Dose Liquid Formulation (Drug)
SAD-3(Treatment group)
6 Participants in the SAD-3(Treatment group) arm received a single oral dose of BCD101-2(3 sachets).
BCD101-2 is a high-dose liquid formulation containing 4 g of the active ingredient per 10 g sachet.
This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
干预措施: BCD101 High Dose Liquid Formulation (Drug)
SAD-4(Treatment group)
6 Participants in the SAD-4(Treatment group) arm received a single oral dose of BCD101-2(4 sachets).
BCD101-2 is a high-dose liquid formulation containing 4 g of the active ingredient per 10 g sachet.
This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
干预措施: BCD101 High Dose Liquid Formulation (Drug)
MAD-2(Treatment group)
6 Participants in the MAD-2(Treatment group) arm received BCD101-2(1 sachet), administered orally twice daily for 7 consecutive days.
BCD101-2 is a high-dose liquid formulation containing 4 g of the active ingredient per 10 g sachet.
This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
干预措施: BCD101 High Dose Liquid Formulation (Drug)
MAD-3(Treatment group)
6 Participants in the MAD-3(Treatment group) arm received a combination of BCD101-1(1 sachet) and BCD101-2(1 sachet), administered orally twice daily for 7 consecutive days.
BCD101-1 is a low-dose liquid formulation containing 2 g of the active ingredient per 10 g sachet, while BCD101-2 is a high-dose liquid formulation containing 4 g of the active ingredient per 10 g sachet.
This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
干预措施: BCD101 Low + High Dose Liquid Formulation (Drug)
SAD-1(Placebo group)
2 Participants in the SAD-1(Placebo group) arm received a single oral dose of BCD101-P(2 sachets).
BCD101-P is a placebo liquid formulation identical in appearance and volume to BCD101-1, containing no active ingredient.
This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
干预措施: BCD101 Placebo Liquid Formulation (Drug)
SAD-2(Placebo group)
2 Participants in the SAD-2(Placebo group) arm received a single oral dose of BCD101-P(2 sachets).
BCD101-P is a placebo liquid formulation identical in appearance and volume to BCD101-2, containing no active ingredient.
This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
干预措施: BCD101 Placebo Liquid Formulation (Drug)
SAD-4(Placebo group)
2 Participants in the SAD-4(Placebo group) arm received a single oral dose of BCD101-P(4 sachets).
BCD101-P is a placebo liquid formulation identical in appearance and volume to BCD101-2, containing no active ingredient.
This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
干预措施: BCD101 Placebo Liquid Formulation (Drug)
MAD-1(Placebo group)
2 Participants in the MAD-1(Placebo group) arm received BCD101-P(1 sachet), administered orally twice daily for 7 consecutive days.
BCD101-P is a placebo liquid formulation identical in appearance and volume to BCD101-1, containing no active ingredient.
This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
干预措施: BCD101 Placebo Liquid Formulation (Drug)
MAD-2(Placebo group)
2 Participants in the MAD-2(Placebo group) arm received BCD101-P(1 sachet), administered orally twice daily for 7 consecutive days.
BCD101-P is a placebo liquid formulation identical in appearance and volume to BCD101-2, containing no active ingredient.
The study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
干预措施: BCD101 Placebo Liquid Formulation (Drug)
MAD-3(Placebo group)
2 Participants in the MAD-3(Placebo group) arm received BCD101-P(2 sachets), administered orally twice daily for 7 consecutive days.
BCD101-P is a placebo liquid formulation identical in appearance and volume to the active formulations, containing no active ingredient.
This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
干预措施: BCD101 Placebo Liquid Formulation (Drug)
MAD-1(Treatment group)
6 Participants in the MAD-1(Treatment group) arm received BCD101-1(1 sachet), administered orally twice daily for 7 consecutive days.
BCD101-1 is a low-dose liquid formulation containing 2 g of the active ingredient per 10 g sachet.
This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
干预措施: BCD101 Low Dose Liquid Formulation (Drug)
结局指标
主要结局
Physical Examination Abnormalities (MAD)
时间窗: Screening, Day -1, Day 1, Day 7, post-study visit (Day 8-12)
A complete physical examination will be performed, and findings will be categorized as normal, not clinically significant (NCS), or clinically significant (CS). Only clinically significant (CS) findings will be classified as abnormalities for this outcome measure. Non-clinically significant deviations (NCS) will not be classified as abnormalities. The number of participants with clinically significant abnormalities will be reported.
Vital signs: Systolic and Diastolic Blood Pressure (MAD)
时间窗: Screening, Day -1 through Day 7, and post-study visit (Day 8-12)
Systolic and diastolic blood pressure will be measured after at least three minutes of rest in the seated position.
Vital signs: Heart Rate (MAD)
时间窗: Screening, Day -1 through Day 7, and post-study visit (Day 8-12)
Heart rate will be measured after at least three minutes of rest in the seated position.
Vital signs: Body Temperature (MAD)
时间窗: Screening, Day -1 through Day 7, and post-study visit (Day 8-12)
Body temperature will be measured after at least three minutes of rest in the seated position.
Electrocardiogram (ECG) Abnormalities (MAD)
时间窗: Screening, Day -1, Day 1, Day 7, post-study visit (Day 8-12)
A standard 12-lead electrocardiogram will be performed, and ECG findings will be categorized as normal, not clinically significant (NCS), or clinically significant (CS). Only clinically significant (CS) findings will be classified as ECG abnormalities for this outcome measure. Non-clinically significant deviations (NCS) from reference ranges will not be classified as abnormalities. The number of participants with clinically significant abnormalities will be reported.
Laboratory Abnormalities (SAD)
时间窗: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Clinical laboratory tests will include hematology, clinical chemistry, urinalysis, serology, and urine drug screening. Laboratory findings will be categorized as normal, not clinically significant (NCS), or clinically significant (CS). Only clinically significant (CS) findings will be classified as laboratory abnormalities for this outcome measure. Non-clinically significant deviations (NCS) from reference ranges will not be classified as abnormalities. The number of participants with clinically significant abnormalities will be reported.
Vital signs: Systolic and Diastolic Blood Pressure (SAD)
时间窗: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Systolic and diastolic blood pressure will be measured after at least three minutes of rest in the seated position.
Vital signs: Heart Rate (SAD)
时间窗: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Heart rate will be measured after at least three minutes of rest in the seated position.
Vital signs: Body Temperature (SAD)
时间窗: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Body temperature will be measured after at least three minutes of rest in the seated position.
Electrocardiogram (ECG) Abnormalities (SAD)
时间窗: Screening, Day -1, Day 1, post-study visit (Day 4-7)
A standard 12-lead electrocardiogram will be performed, and ECG findings will be categorized as normal, not clinically significant (NCS), or clinically significant (CS). Only clinically significant (CS) findings will be classified as ECG abnormalities for this outcome measure. Non-clinically significant deviations (NCS) from reference ranges will not be classified as abnormalities. The number of participants with clinically significant abnormalities will be reported.
Number of Participants With Adverse Events (MAD)
时间窗: Day -1 through Day 7, and post-study visit (Day 8-12)
All adverse events occurring during the clinical trial following a multiple ascending dose of BCD101 will be collected and evaluated for seriousness, severity, and their relationship to the investigational product. Events will be coded using MedDRA System Organ Class and Preferred Term.
Number of Participants With Adverse Events (Single-Ascending Dose, SAD)
时间窗: Day -1, Day 1, post-study visit (Day 4-7)
All adverse events occurring during the clinical trial following a single ascending dose of BCD101 will be collected and evaluated for seriousness, severity, and their relationship to the investigational product. Events will be coded using MedDRA System Organ Class and Preferred Term.
Physical Examination Abnormalities (SAD)
时间窗: Screening, Day -1, Day 1, post-study visit (Day 4-7)
A complete physical examination will be performed, and findings will be categorized as normal, not clinically significant (NCS), or clinically significant (CS). Only clinically significant (CS) findings will be classified as abnormalities for this outcome measure. Non-clinically significant deviations (NCS) will not be classified as abnormalities. The number of participants with clinically significant abnormalities will be reported.
Laboratory Abnormalities (MAD)
时间窗: Screening, Day -1, Day 1, Day 6-7, post-study visit (Day 8-12)
Clinical laboratory tests will include hematology, clinical chemistry, urinalysis, serology, and urine drug screening. Laboratory findings will be categorized as normal, not clinically significant (NCS), or clinically significant (CS). Only clinically significant (CS) findings will be classified as laboratory abnormalities for this outcome measure. Non-clinically significant deviations (NCS) from reference ranges will not be classified as abnormalities. The number of participants with clinically significant abnormalities will be reported.
次要结局
- Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD)(Day 1 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau,ss) (MAD)(Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameter: Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) (SAD)(Day 1 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameter: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) (SAD)(Day 1 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) (SAD)(Day 1 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameter: Terminal Elimination Half-Life (t1/2) (SAD)(Day 1 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameter: Maximum Plasma Concentration at Steady State (Cmax,ss) (MAD)(Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameter: Area Under the Concentration-Time Curve From Time Zero to Infinity at Steady State (AUCinf,ss) (MAD)(Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameter: Time to Maximum Plasma Concentration at Steady State (Tmax,ss) (MAD)(Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameter: Terminal Elimination Half-Life at Steady State (t1/2,ss) (MAD)(Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameter: Accumulation Ratio (Rac) (MAD)(Day 1 (pre-dose through 12 hours post-dose), Day 7 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameters: Terminal Elimination Half-Life at Steady State (t1/2,ss) (MAD)(Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameters: Area Under the Concentration-Time Curve (AUC₀-t) (SAD)(Day 1 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) (SAD)(Day 1 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax) (SAD)(Day 1 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameters: Terminal Elimination Half-Life (t1/2) (SAD)(Day 1 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameters: Maximum Plasma Concentration at Steady State (Cmax,ss) (MAD)(Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Extrapolated to Infinity at Steady State (AUCinf,ss) (MAD)(Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameters: Time to Maximum Concentration at Steady State (Tmax,ss) (MAD)(Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose))
- Pharmacokinetic Parameters: Accumulation Ratio (Rac) (MAD)(Day 1 (pre-dose through 12 hours post-dose), Day 7 (pre-dose through 12 hours post-dose))