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临床试验/NCT06627556
NCT06627556招募中1 期

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of H021 in Healthy Participants

Jiangsu Carephar Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年9月17日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
64
试验地点
1
主要终点
Number of Participants with Adverse Events (AEs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants.

详细描述

This is a single center, Phase 1, randomized, double-blind, placebo controlled, sequential single ascending dose/multiple ascending dose (SAD/MAD) study, with a food-effect arm. The study will be divided into two parts:

  • SAD cohorts, with food-effect evaluation
  • MAD cohorts The two parts will be completed sequentially but with partial overlapping. The MAD phase can start once safety, tolerability, and pharmacokinetic data from the SAD phase show that single doses of at least 25 mg are acceptable. If the 25 mg dose will be not reached in the SAD phase, the Safety Review Committee (SRC) will set a new starting dose.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 55 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), greater than and equal to (>=) 18 and less than and equal to (<=) 55 years of age, with body mass index (BMI) greater than (>)18.5 and less than (<) 32.0 kilograms per square meter (kg/m^2).
  • •Healthy as defined by:
  • •the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
  • •the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
  • •Female participants of non-childbearing potential must be:
  • •post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented follicle-stimulating hormone (FSH) levels >=40 milli-international units per milliliter (mIU/mL); or
  • •surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or bilateral tubal occlusion) at least 3 months prior to dosing.
  • •Participants must be willing not to donate sperm for 90 days or ova (egg) for 6 months after the last dose.
  • •Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
  • •Able to understand the study procedures and provide signed informed consent to participate in the study.

排除标准

  • •Any clinically significant abnormal finding at physical examination.
  • •Clinically significant abnormal laboratory test results including biochemistry, hematology, urinalysis, and coagulation results, or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, or QuantiFERON®-TB test at screening.
  • •Positive pregnancy test or lactating female participant.
  • •Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -
  • •History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
  • •Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood pressure lower than 90 or over 140 millimetres of mercury (mmHg), diastolic blood pressure lower than 40 or over 90 mmHg, heart rate less than 40 or over 100 beats per minute (bpm), respiratory rate less than 10 or over 22 bpm), or oxygen saturation less than 95 percent (%) oxygen at screening.
  • •History of drug abuse within 1 year prior to screening as determined by the investigator.
  • •History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 1 month prior to screening that exceeds 10 units of alcohol per week for women and men (1 unit = 375 [milliliter] mL of beer 3.5%, 100 mL of wine 13.5%, or 30 mL of distilled alcohol 40%).
  • •History of active tuberculosis or presence of active or latent tuberculosis. Previous latent tuberculosis that has been treated and is no longer active is not exclusionary.
  • •History of clinically significant opportunistic infection (example, invasive candidiasis or pneumocystis pneumonia).
  • •History of serious local infection (example, cellulitis, abscess) or systemic infection (example, septicemia) within 3 months prior to screening.
  • •Presence of fever (body temperature greater than (>) 37.5 degrees Celsius (°C) (example, a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.
  • •Use of medications within the timeframes specified.
  • •Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or simultaneous participation in an investigational study involving no drug or device administration.
  • •Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
  • •Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

研究组 & 干预措施

SAD Cohort 1: H021 6.25 milligrams (mg)

Experimental

Participants will receive H021, 6.25 mg oral tablet, as single-dose on Day 1 under fasting or fed conditions.

干预措施: H021 (Drug)

SAD Cohort 2: H021 12.5 mg

Experimental

Participants will receive H021, 12.5 mg oral tablet, as single-dose on Day 1 under fasting conditions.

干预措施: H021 (Drug)

SAD Cohort 3: H021 25 mg

Experimental

Participants will receive H021, 25 mg oral tablet, as single-dose on Day 1 under fasting conditions.

干预措施: H021 (Drug)

SAD Cohort 4: H021 50 mg

Experimental

Participants will receive H021, 50 mg oral tablet, as single-dose on Day 1 under fasting conditions.

干预措施: H021 (Drug)

SAD Cohort 5: H021 100 mg

Experimental

Participants will receive H021, 100 mg oral tablet, as single-dose on Day 1 under fasting conditions.

干预措施: H021 (Drug)

MAD Cohort 6: H021 12.5 mg

Experimental

Participants will receive H021, 12.5 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions.

干预措施: H021 (Drug)

MAD Cohort 7: H021 25 mg

Experimental

Participants will receive H021, 25 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions.

干预措施: H021 (Drug)

MAD Cohort 8: H021 50 mg

Experimental

Participants will receive H021, 50 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions.

干预措施: H021 (Drug)

SAD-H021 Placebo

Placebo Comparator

Participants will receive H021, placebo oral tablet, as single-dose on Day 1 under fasting or fed conditions.

干预措施: H021 Placebo (Drug)

MAD-H021 Placebo

Placebo Comparator

Participants will receive H021, placebo oral tablet once daily from Day 1 to Day 7 under fasting conditions.

干预措施: H021 Placebo (Drug)

结局指标

主要结局

Number of Participants with Adverse Events (AEs)

时间窗: Up to final follow-up (SAD Part: up to 8 days: MAD Part: up to 14 days)

An AE is defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any clinically significant changes in vital signs, electrocardiogram (ECG) measurement, physical examination and clinical laboratory parameters will be recorded as AE.

次要结局

  • SAD Part: Area under the concentration-time curve from time zero until the last observed concentration (AUC0-t) of H021(pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose)
  • SAD Part: Area under the concentration-time curve from time zero to infinity (AUC0-infinity) of H021(pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose)
  • SAD Part: Maximal observed concentration (Cmax) of H021(pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose)
  • SAD Part: Time to Reach Cmax (Tmax) of H021(pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose)
  • SAD Part: Lag Time (Tlag) of H021(pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose)
  • SAD Part: Residual area of H021(pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24), and 48 hours post-dose)
  • SAD Part: Terminal elimination half-life (T1/2 el) of H021(pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose)
  • SAD Part: Terminal elimination rate constant (Kel) of H021(pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose)
  • SAD Part: Apparent clearance (CL/F) of H021(pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose)
  • SAD Part: Apparent volume of distribution (Vz/F) of H021(pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose)
  • SAD Part: Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t) of H021(pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose)
  • SAD Part: Maximal Rate of Urinary Excretion (Rmax) of H021(pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose)
  • SAD Part: Time of Maximal Urinary Excretion (TRmax) of H021(pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose)
  • SAD Part: Renal Clearance (CLR) of H021(pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose)
  • MAD Part: Area under the concentration-time curve from time zero to time 24 hours (AUC0-24) of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: Cmax of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: Tmax of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: Area under the concentration-time curve for one dosing interval (τ) at steady- state (AUC0-τ) of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: Cmax ss of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: Tmax ss of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: Minimal observed concentration at steady-state (Cmin ss) of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: AUC0-t of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: AUC0-inf of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: Residual area of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: T½ el of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: Kel of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: Apparent clearance at steady-state (Clss/F) of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: Apparent volume of distribution at steady-state (Vz ss/F) of H021(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: Accumulation ratio (RAUC)(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)
  • MAD Part: Accumulation Ratio (RCmax)(Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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