A Phase 1, Randomised, Double-Blind, Placebo-Controlled, First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Subcutaneous HTL0022562 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
Phase 1, randomised, double-blind, first in human, two part, single centre, placebo controlled, single and multiple ascending dose trial in healthy adult subjects to evaluate the safety, tolerability and pharmacokinetics of HTL0022562.
详细描述
This is a first in human, two part, double blind, placebo controlled, randomised single and multiple ascending subcutaneous dose study to evaluate the safety, tolerability and pharmacokinetics of HTL0022562.
Part 1 comprises of 7 sequential ascending dosing cohorts and Part 2 comprises of 4 multiple ascending dosing cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Healthy males or healthy females of non-childbearing potential (WoNCBP) aged 18 to 55 years inclusive, with a body mass index >18.5-<30kgm2 and body weight ≥50kg.
- •Healthy on the basis of a clinical history, physical examination, electrocardiogram (ECG), vital signs and laboratory tests of blood and urine.
- •Willingness to comply with requirements or the trial, including contraception requirements.
- •Able to give fully informed consent.
排除标准
- •Confirmed current Coronavirus Disease 2019 (COVID 19) infection before randomisation.
- •Clinical signs and symptoms consistent with COVID 19 (e.g. fever, dry cough, dyspnoea, sore throat, or fatigue) or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening or on admission.
- •Suffered from severe course of COVID 19 (extracorporeal membrane oxygenation (ECMO), mechanically ventilated).
- •Receipt of any investigational medicinal product (IMP) in a clinical research study within the previous 3 months (or 5 half-lives, whichever is longer) of Screening.
- •Any abnormalities on 12-lead ECG or BP at Screening (as specified).
- •History of any drug or alcohol abuse in the past 2 years.
- •Vital signs outside the normal range for healthy volunteers
- •Clinically significant abnormal biochemistry, haematology, coagulation, or urinalysis
- •Abnormal renal function, hepatic function or history of abnormal hepatic function occurring during treatment with investigational or licensed drugs, which led to permanent discontinuation of treatment.
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV), or human immunodeficiency virus (HIV)
- •History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, or current hepatic renal dysfunction as judged by the investigator.
- •Risk factor for ischaemic heart disease or cerebrovascular disease.
- •Failure to satisfy, in the Investigator's judgement, the subject's fitness to participate for any other reason, including previous serious adverse reaction or serious hypersensitivity reactions to any drug or formulation excipients administered parenterally or orally.
- •All female subjects must have a negative serum and urine pregnancy test at Screening and admission, respectively.
研究组 & 干预措施
Part 1 Single Ascending Dose
Eight subjects in up to 7 cohorts will be dosed. One or more subcutaneous injections of HTL0022562 will be administered. In each cohort, 6 subjects will receive HTL0022562 and 2 subjects will receive placebo.
干预措施: HTL0022562 (Drug)
Part 1 Single Ascending Dose
Eight subjects in up to 7 cohorts will be dosed. One or more subcutaneous injections of HTL0022562 will be administered. In each cohort, 6 subjects will receive HTL0022562 and 2 subjects will receive placebo.
干预措施: Placebo (Drug)
Part 2 Multiple Ascending Dose
Eight subjects in up to 4 cohorts will be dosed, following safety, tolerability and pharmacokinetic (PK) review of completed dose of Single Ascending Dose Cohort 5. In each cohort, 6 subjects will receive HTL0022562 and 2 subjects will receive placebo.
干预措施: HTL0022562 (Drug)
Part 2 Multiple Ascending Dose
Eight subjects in up to 4 cohorts will be dosed, following safety, tolerability and pharmacokinetic (PK) review of completed dose of Single Ascending Dose Cohort 5. In each cohort, 6 subjects will receive HTL0022562 and 2 subjects will receive placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Treatment Emergent Adverse Events (TEAEs)
时间窗: Screening up to post last dose: Day 8 (Part 1) / Day 15 (Part 2)
All Adverse Events (AEs), including clinical laboratory, vitals signs, body temperature, respiratory rate, physical examinations, local tolerability and site injection reactions, and ECGs will be analyzed in all subjects.
次要结局
- Part 1 and Part 2: Area Under Curve (AUC)(Part 1 up to Day 8, Part 2 up to Day 15)
- Part 1 and Part 2: Ae(Part 1 up to Day 8, Part 2 up to Day 15)
- Part 1 and Part 2: Tmax(Part 1 up to Day 8, Part 2 up to Day 15)
- Part 1 and Part 2: Cmax(Part 1 up to Day 8, Part 2 up to Day 15)