NCT07693738招募中1 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of SSGJ-716 Injection Administered Subcutaneously in Healthy Chinese Adults and Participants With Moderate-to-Severe Atopic Dermatitis
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
- 96
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
The purpose of this Phase 1 study is to evaluate the safety and tolerability of a new investigational drug called SSGJ-716 in healthy adults and in participants with moderate-to-severe atopic dermatitis (AD).
The study has two parts. The first part (Single Ascending Dose, SAD) will enroll healthy adults.The second part (Multiple Ascending Dose, MAD) will enroll participants with moderate-to-severe AD.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand protocol requirements and sign a written ICF.
- •Male or female subjects aged 18-45 years when signing the ICF.
- •Male subjects with body weight ≥ 50 kg, and female subjects with body weight ≥ 45 kg. Subjects with BMI between 18 and 28 kg/m
- •Subjects whose test results are normal, or abnormal without clinical significance as determined by the investigator.
- •Female subjects with childbearing potential and male subjects (and their female partners) must agree to take highly effective contraceptive measures.
排除标准
- •History of severe allergy, or with a history of allergy to the study treatment or related excipients.
- •With any clinically significant diseases prior to the screening visit. Subjects with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody.
- •History of of significant alcohol abuse.
- •History of significant drug abuse.
- •Subjects who have positive result for urine nicotine test at screening. Pregnant, or nursing females.
研究组 & 干预措施
SSGJ-716
Experimental
干预措施: SSGJ-716 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
时间窗: 85 days
次要结局
- Maximum observed concentration (Cmax)(85 days)
- Time to maximum concentration (Tmax)(85 days)
- Elimination half-life (t1/2)(85 days)
- Area under the concentration-time curve from time zero to last measurable concentration (AUC0-last)(85 days)
- Incidence of Anti-Drug Antibody (ADA)(85 days)
研究者
研究点 (1)
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