A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence, frequency, and severity of adverse events (AEs)
研究概览
简要总结
This study aims to assess the safety and tolerability of ABCL575 in healthy participants following single ascending dose (SAD), in comparison to a placebo
详细描述
This is a phase I randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The study will consist of 5 planned cohorts (A1 to A5), each comprised of 8 healthy participants. Doses of ABCL575 are intended to escalate through cohorts A1 to A5.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female ≥ 18 and ≤ 65 years of age at the time of screening
- •Good general health as determined through medical history and general physical examination
- •Body weight ≥ 50 and ≤ 100 Kg
- •Body mass index (BMI) between 18.5 kg/m2 and 30.0 kg/m2
- •Non- or ex-smoker (an ex-smoker defined as someone who has completely stopped using nicotine products for at least 180 days prior to study drug administration)
- •Meeting 1 of the following:
- •Is of childbearing potential or able to procreate and agrees to use an acceptable contraceptive method from the time of signing the ICF through the EOS visit.
- •Is of nonchildbearing potential or unable to procreate
- •If male, agrees not to donate sperm from the study drug administration through EOS visit; If female, agrees not to donate or retrieve eggs from the study drug administration through EOS visit
排除标准
- •Pregnancy and/or lactation.
- •Seated pulse rate less than 50 beats per minute (bpm) or more than 100 bpm or a seated blood pressure < 90/50 mmHg or > 140/90 mmHg
- •eGFR < 60 mL/min/1.73 m2
- •Severe hypersensitivity reactions (like angioedema) to any drugs.
- •Presence or history of significant gastrointestinal, liver disease, kidney disease, or surgery that may affect drug bioavailability.
- •History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease.
- •History or presence of multiple or severe drug allergies.
- •Evidence of any active bacterial, viral, or fungal infection
- •Disrupted skin integrity (apparent burn or dermatitis).
- •History of syncope, palpitations, or unexplained dizziness.
- •Use of prescription drugs (except for hormonal contraceptives or hormone replacement therapy) in the 28 days prior to study drug administration, that in the opinion of an investigator would put into question the participant's healthy status.
- •Use of any over-the-counter products in the 7 days or 5 half-lives (whichever is longer) prior to study drug administration.
- •Receipt of live vaccines within 5 weeks prior to screening or plans to receive live vaccines within 180 days after study drug administration.
- •History of latent or active tuberculosis.
- •History of herpes zoster (shingles) or RZV (eg, Shingrix) vaccination within 28 days prior to screening or scheduled during the study period
研究组 & 干预措施
Placebo
Healthy participants will receive a single dose of placebo administered by subcutaneous (SC) injection
干预措施: Placebo (Normal Saline 0.9%) (Biological)
ABCL575
Healthy participants will receive a single dose of ABCL575 administered by subcutaneous (SC) injection
干预措施: ABCL575 (Biological)
结局指标
主要结局
Incidence, frequency, and severity of adverse events (AEs)
时间窗: Day 0 to day 337
Changes from baseline in physical examination
时间窗: Day 0 to day 337
Changes from baseline in vital signs
时间窗: Day 0 to day 337
Changes from baseline in laboratory parameters including general biochemistry, lipid profile, coagulation, hematology, and urinalysis
时间窗: Day 0 to day 337
Changes from baseline in 12-lead safety ECGs
时间窗: Day 0 to day 337
Incidence and severity of injection site reactions
时间窗: Day 0 to day 337
次要结局
- Plasma concentrations of ABCL575(Day 0 to day 337)
- Incidence of anti-ABCL575 antibodies(Day 0 to day 337)
- PK parameters; maximum plasma concentration (Cmax)(Day 0 to day 337)
- PK parameters; time to maximum plasma concentration (Tmax)(Day 0 to day 337)
- PK parameters; area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-T)(Day 0 to day 337)
- PK parameters; area under the plasma concentration-time curve from zero to hour 672 (AUC0-672)(Day 0 to day 337)
- PK parameters; area under the plasma concentration-time curve from zero to infinity (AUC0-∞)(Day 0 to day 337)
- PK parameters; terminal rate constant (λz)(Day 0 to day 337)
- PK parameters; apparent plasma clearance of drug after extravascular administration (CL/F)(Day 0 to day 337)
- PK parameters; apparent volume of distribution after extravascular administration (Vz/F)(Day 0 to day 337)
- PK parameters; half-life (Thalf)(Day 0 to day 337)