NCT06999083已完成1 期
A Phase Ia, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0043 in Healthy Adult Subjects
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Percentage of subjects with drug related adverse events (AEs)
研究概览
简要总结
The aim of this study is to investigate the safety and tolerability of HB0043 in healthy subjects following single-dose.
详细描述
This is a single-dose escalation study of HB0043 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0043.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects must meet the following criteria to be eligible for study entry:
- •Healthy male or female subjects age ≥ 18 and ≤ 55 years.
- •Men and women of reproductive potential, willing to practice a highly effective method of birth control for the duration of the study and continuing for 6 months after receiving the last dose of drug administration. Highly effective methods of birth control include sexual abstinence (men, women); vasectomy or a condom (men) in combination with other barrier methods, hormonal birth control or IUD (women).
- •Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m².
- •No clinically significant findings in the medical history and physical examination.
- •No clinically significant laboratory values (including urinalysis), unless the investigator considers any abnormality to not be clinically significant.
- •Normal ECG, blood pressure, respiratory rate, temperature and heart rate, unless the investigator considers any abnormality to be not clinically significant.
- •Informed consent must be obtained for all subjects enrolled into the study.
排除标准
- •Subjects who meet any of the following criteria will be excluded from study entry:
- •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease.
- •Current or history of malignancy.
- •Family history of premature Coronary Heart Disease (CHD).
- •Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ. Exposure to any prescription medication 14 days prior to randomization, to herbal remedies or over-the countermedications (except for the occasional use of acetaminophen [up to 2,000 mg per day]) 7 days prior to randomization.
- •Participation in another research with any investigational product within 28 days or 5 half-lives of the drug, whichever is greater, before screening.
- •Known allergy to biologics.
- •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
- •Had a vaccination with a live attenuated vaccine within 1 months prior to dosing.
- •Subjects at risk for tuberculosis (TB), specifically subjects with:
- •Current clinical, radiographic or laboratorial evidence of active TB;
- •Positive interferon-γ release assay (IGRA) test.
- •Positive test at screening for any of the following infectious disease tests: Hepatitis B, surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), Human immunodeficiency virus antibody (HIV Ab).
- •History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
- •A helminth parasitic infection diagnosed within 6 months prior to screening that has not been treated with, or has failed to respond to, standard of care therapy.
- •Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
- •Presence of fever (body temperature >37.5°C) (e.g., a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to the first dosing.
- •History of drug abuse within 1 year prior to screening, or use of soft drugs (such as marijuana) within 3 months prior to the screening, or hard drugs (such as cocaine, phencyclidine, and crack) within 1 year prior to screening. Positive drug screen (cocaine, methamphetamine, phencyclidine, and Tetrahydrocannabinol) at screening or Day -
- •History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening. Positive Breath Alcohol Test at screening or Day -
- •Current cigarette smoker (cigarettes or e-cigarettes) who smoke over 5 cigarettes/day within 3 months prior to screening.
- •Mental condition rendering the subject incapable of understanding the nature, scope, and possible consequences of the study.
- •Pregnant or Breasting feeding subject. Women with positive pregnancy test (hCG). Or subjects who plan to donate sperms or eggs, from dosing until at least 6 months after last dose of investigational medicine.
- •Adults under guardianship and people with restriction of freedom by administrative and legal decisions.
- •Unlikely to comply with the clinical study protocol, e.g. uncooperative attitude, inability to return for followed-up visit, and improbability of completing the study.
- •Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the study.
研究组 & 干预措施
HB0043 dose group 2
Active Comparator
HB0043 single dose
干预措施: HB0043 (Drug)
HB0043 dose group 3
Active Comparator
HB0043 single dose
干预措施: HB0043 (Drug)
HB0043 dose group 4
Active Comparator
HB0043 single dose
干预措施: HB0043 (Drug)
HB0043 dose group 5
Active Comparator
HB0043 single dose
干预措施: HB0043 (Drug)
HB0043 dose group 6
Active Comparator
HB0043 single dose
干预措施: HB0043 (Drug)
HB0043 dose group 1
Active Comparator
HB0043 single dose
干预措施: HB0043 (Drug)
Matching placebo for each dose group
Placebo Comparator
placebo, single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects with drug related adverse events (AEs)
时间窗: Up to 1200 hours
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
次要结局
- Cmax(Up to 1200 hours)
- AUC0-infinity(Up to 1200 hours)
研究者
研究点 (2)
Loading locations...
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