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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events (Single-Ascending Dose, SAD)
Study Overview
Brief Summary
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 serious adverse events and serious adverse drug reactions (Serious AEs/ADRs).
- Collection of blood samples for pharmacokinetic analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: BCD101 High Dose 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.
The study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
Intervention: BCD101 Low 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.
The study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
Intervention: 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.
The study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
Intervention: 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.
Intervention: 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.
Intervention: BCD101 Placebo Liquid Formulation (Drug)
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.
Intervention: 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.
Intervention: 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.
The study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
Intervention: 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.
Intervention: 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.
The study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
Intervention: BCD101 Placebo Liquid Formulation (Drug)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events (Single-Ascending Dose, SAD)
Time Frame: 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. \[Unit of Measure\] Participants
Physical Examination Abnormalities (SAD)
Time Frame: 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. \[Unit of Measure\] Participants
Vital signs: Systolic and Diastolic Blood Pressure (SAD)
Time Frame: 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. \[Unit of Measure\] mmHg
Vital signs: Heart Rate (SAD)
Time Frame: 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. \[Unit of Measure\] Beats per minute (bpm)
Vital signs: Body Temperature (SAD)
Time Frame: 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. \[Unit of Measure\] °C
Electrocardiogram (ECG) Abnormalities (SAD)
Time Frame: 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. \[Unit of Measure\] Participants
Laboratory Abnormalities (SAD)
Time Frame: 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. \[Unit of Measure\] Participants
Number of Participants With Adverse Events (MAD)
Time Frame: 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. \[Unit of Measure\] Participants
Vital signs: Systolic and Diastolic Blood Pressure (MAD)
Time Frame: 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. \[Unit of Measure\] mmHg
Vital signs: Body Temperature (MAD)
Time Frame: 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. \[Unit of Measure\] °C
Physical Examination Abnormalities (MAD)
Time Frame: 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. \[Unit of Measure\] Participants
Vital signs: Heart Rate (MAD)
Time Frame: 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. \[Unit of Measure\] Beats per minute (bpm)
Electrocardiogram (ECG) Abnormalities (MAD)
Time Frame: 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. \[Unit of Measure\] Participants
Laboratory Abnormalities (MAD)
Time Frame: 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. \[Unit of Measure\] Participants
Secondary Outcomes
- Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD)(Day 1 (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 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 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: 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: Accumulation Ratio (Rac) (MAD)(Day 1 (pre-dose through 12 hours post-dose), Day 7 (pre-dose through 12 hours post-dose))