A Phase I Randomized, Double-Blind, Placebo-Controlled Study Investigating the Safety, Tolerability, and Pharmacokinetics of Single Dose Intravenously Administered HFB30132A, a Monoclonal Antibody Against SARS-CoV-2, in Chinese Healthy Adult Subjects

HiFiBiO Therapeutics1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2021年5月9日最近更新: 2022年3月11日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 20
试验地点: 1
主要终点: Number of participants with treatment emergent serious adverse events (TESAEs)

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 purpose of this study is to examine the safety and tolerability of HFB30132A when it is given by single intravenous infusion in Chinese healthy participants.

详细描述

This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study in Chinese healthy volunteers.

The study will comprise of:

A Screening Period of up to 30 days (Day -30 through Day -1);
A Treatment Period during which participants will be resident at the Observation Unit from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day 1) until at least 48 hours (Day 3) after IMP administration. Participants will be discharged on Day 3 after all safety and/or pharmacokinetic (PK) evaluations have been completed, and
A Follow up Period lasting 270 days after the IMP 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: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Subject is a healthy male or female subject, aged between 18 to 60 years (inclusive). A Body Mass Index (BMI) of between 18 to 30 kilograms per square meter (kg/m^2) inclusive, and a body weight of ≥45 kg for female, ≥50 kg for male.
•Health is defined as no clinically relevant abnormalities identified by Investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurement, electrocardiogram (ECG) and clinical laboratory tests prior to the study drug administration.
•Subject voluntarily has given written informed and is willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, methods of contraception
•Female subjects of childbearing potential must not be planning a pregnancy or be pregnant or lactating. All female subjects must have a negative result for the pregnancy tests performed at screening and admission.
•For female subjects of childbearing potential: must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit
•Female subject of non-childbearing potential defined as surgically sterile (i.e. documented bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or at least 12 months postmenopausal.
•Male subjects with partners of childbearing potential must have had surgical sterilization (vasectomy) at least 26 weeks prior to screening or use a male barrier method of contraception (i.e. male condom with spermicide) during any sexual intercourse, from Study Day -1 (beginning of confinement) until 3 months after the final Follow-up Visit. Note: complete abstinence from sexual intercourse is acceptable.
•Male subjects must agree to abstain from sperm donation from initial study drug administration through 3 months after the last Follow-up Visit.
•Subject voluntarily agrees to participate in this study and has given written informed consent prior to undergoing any of the screening procedures.

排除标准

•History or symptoms of any clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, pulmonary, hematological, autoimmune, psychiatric disease, metabolic disorder.
•History of pulmonary tuberculosis and clinically significant abnormal chest CT results
•History of drug or alcohol abuse within 1 year prior to screening, or positive test for drugs of potential abuse at screening and admission, where alcohol abuse is defined as regular consumption exceeding 7 drinks/ week for women, and 14 drinks/ week for men.
•Use of any medications started within 14 days (or 5 half-lives, whichever is longer) prior to study drug administration including, prescription medications, nutritional supplements, and over-the-counter medications
•Blood donation of approximately 500 mL within 60 days prior to dosing, or donation of more than 200 mL within 30 days, or receipt of any transfused blood products within 60 days prior to the screening visit
•Receipt of treatment or vaccination against SARS-CoV-2 within 90 days prior to dosing, or planning for vaccination against SARS-CoV-2 from screening to 90 days after dosing
•Receipt of influenza vaccination within 4 weeks before screening or planning to receive influenza vaccination from screening to 90 days after dosing
•Symptoms of acute respiratory tract infection within 28 days before dosing
•Febrile illness within 28 days prior to the first dose of study drug, or other signs or symptoms consistent with SARS-CoV-2 infection in the judgement of the Investigator in the 14 days prior to the first dose of study drug.
•Hospitalization for any reason within 60 days prior to the screening visit
•Participation (defined as receipt of dose of investigational agent) in any clinical research study evaluating another investigational drug or therapy within 3 months prior to the screening visit
•History of or positive human immunodeficiency virus (HIV) screen result, or positive blood test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or subjects with positive hepatitis C virus (HCV) antibody.
•Subject is confirmed as positive by SARS-CoV-2 RT-PCR or antibody testing

研究组 & 干预措施

HFB30132A

Experimental

Participants will receive HFB30132A administered across 2 fixed-dose cohorts via intravenous infusions (to be administered sequentially)

干预措施: HFB30132A (Drug)

Placebo

Placebo Comparator

Placebo will be administered to participants across three fixed-dose cohorts similar to the active treatment.

干预措施: Placebo (Other)

结局指标

主要结局

Number of participants with treatment emergent serious adverse events (TESAEs)

时间窗: From Day 1 to up to Day 30 after the single dose administration of HFB30132A

Number of participants experiencing TESAEs

Number of participants with treatment emergent adverse events of special interest (TEAESI)

时间窗: From Day 1 to up to Day 30 after the single dose administration of HFB30132A

Safety and tolerability will be evaluated in terms of number of participants with TEAESI (hypersensitivity / anaphylactic reaction / local tolerability)

Number of participants with treatment-emergent adverse events (TEAE)

时间窗: From Day 1 to up to Day 30 after the single dose administration of HFB30132A

Safety and tolerability will be evaluated in terms of number of participants with TEAE

Number of participants with changes in laboratory values, vital signs and ECG parameters

时间窗: From Day 1 to up to Day 30 after the single dose administration of HFB30132A

Safety and tolerability will be evaluated in terms of number of participants with changes in laboratory values, vital signs and ECG parameters

Maximum observed serum concentration (Cmax)