NCT05912049招募中1 期
A Phase 1, Randomized, Double-blind，Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Immunogenicity of 9MW3811 in Healthy Participants
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
- 24
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs) as assessed by CTCAE v5.0
研究概览
简要总结
This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants between 18 and 55 years of age, inclusive.
- •Male body weight ≥50.0 kg, or female body weight ≥45.0 kg, and body mass index (BMI) between 18.0 and 26.0 kg/m2, inclusive.
- •In good health determined by the investigator based on a medical evaluation.
排除标准
- •Clinically significant histories determined by the investigator of cardiovascular, hepatic, renal, gastrointestinal, neurological, respiratory, hematological, endocrinological, immunological, metabolic, and musculoskeletal abnormalities.
- •Having any history of an allergy to biological agents or any components of study drug; those who have a history of allergies and judged by the investigator to be ineligible for enrolment.
- •Use of any prescription medication 14 days prior to dosing or over-the-counter medication, vitamins, and/or herbal medicines 7 days prior to dosing (Excluding oral contraception, occasional paracetamol, ibuprofen and standard dose of multivitamins at the discretion of the PI or designee)
- •Participants who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study
- •Participants who received immunosuppressants except for previous use of inhaled or nasal corticosteroids 4 weeks earlier before administration or any oral corticosteroids 8 weeks earlier before administration, and who had received a single dose of monoclonal antibodies for any reason within 1 year prior to screening
- •Participants with one or more clinically significant positive test results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody or human immunodeficiency virus (HIV) antibody
- •History of active tuberculosis, or participants with active or latent tuberculosis infection during screening
- •History of drug abuse including narcotic and psychiatric drugs within 6 months prior to screening or a positive drug abuse test result at baseline (Morphine, Methamphetamine, Tetrahydrocannabinol acid)
研究组 & 干预措施
9MW3811 Injection
Experimental
single dose escalation for experimental drug
干预措施: 9MW3811 Injection (Drug)
Placebo
Placebo Comparator
matching placebo administration for control
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events (AEs) as assessed by CTCAE v5.0
时间窗: up to Day113
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
次要结局
- Maximum Plasma Concentration (Cmax)(up to Day113)
- Time to reach Cmax (Tmax)(up to Day113)
- Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)(up to Day113)
- Terminal elimination half-life (t1/2)(up to Day113)
- AUC from time 0 extrapolated to infinity (AUC0-inf)(up to Day113)
- Volume of distribution (Vz)(up to Day113)
- Terminal elimination rate constant (λz)(up to Day113)
- Apparent clearance (CL)(up to Day113)
- Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline(up to Day113)
研究者
研究点 (1)
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