NCT07040930招募中1 期
A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China
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
- 30
- 试验地点
- 1
- 主要终点
- TEAEs
研究概览
简要总结
This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving 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
- 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
- •Ages 18-55; ≥3 per gender for each cohort.
- •BMI: 18-30; Weight: ≥50 kg (male), ≥45 kg (female).
- •No clinically significant abnormalities in medical history, physical exam, vital signs, or lab/ECG/pulmonary imaging.
- •Men/WOCBP must use effective contraception throughout study; no plans to conceive; WOCBP must have negative pregnancy test and not breastfeeding. Women of non-childbearing potential: post-hysterectomy/salpingectomy or postmenopausal (FSH >40 IU/L).
- •Able to provide informed consent; willing to comply with all study requirements
排除标准
- •Allergy to GenSci120 or severe allergies.
- •Injection site issues affecting evaluation.
- •Significant medical conditions impacting study outcome.
- •History of malignant tumors, including listed cancers.
- •Seizure history, head injury causing unconsciousness.
- •Psychiatric disorders impairing daily activities or cognitive issues.
- •Severe immunodeficiency (e.g., HIV).
- •Recent trauma, surgery, or GI issues affecting absorption.
- •Recent severe infections or antimicrobial treatments.
- •Live vaccines within a month prior to screening.
- •Abnormal vital signs/ECG: BP extremes, QTcF >450ms.
- •Positive for hepatitis B/C, HIV, syphilis during screening.
- •Positive TB test via IGRA.
- •Recent use of immunosuppressive or targeted therapies.
- •Medication use within 14 days prior to randomization.
- •Participation in other clinical trials recently/currently.
- •Excessive alcohol consumption (over six months).
- •Heavy smoking, unwillingness to quit, positive nicotine tests.
- •Positive drug screen for specific substances.
- •Recent soft/hard drug use within specified periods.
- •Blood donation/product receipt recently or poor venous access.
- •Study staff involved in the trial.
- •Other conditions deemed unsuitable by investigators.
研究组 & 干预措施
GenSci120
Experimental
Multiple ascending doses of GenSci120 administered subcutaneously (SC).
干预措施: GenSci120 (Drug)
Placebo
Experimental
Multiple ascending doses of placebo administered subcutaneously (SC).
干预措施: Placebo (Drug)
结局指标
主要结局
TEAEs
时间窗: 169 days
Incidence and severity of treatment-emergent adverse events
CSfadf
时间窗: 169 days
Clinically significant changes from baseline
SAEs
时间窗: 169 days
Incidence and severity of serious adverse events
次要结局
- AUC0-t, AUC0-∞(169 days)
- Tmax(169 days)
- t1/2(half-life)
- cell counts of T cell subset(169 days)
- plasma(169 days)
- Cmax(169 days)
- Time of ADA(169 days)
- CL/F(apparent clearance)
- V/F(169 days)
- RO of T cell subset(169 days)
- Incidence of ADA(169 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT05516966Fujian Shengdi Pharmaceutical Co., Ltd.64
已完成
1 期
Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic MalignanciesB-cell Non-Hodgkins LymphomaChronic Lymphocytic LeukemiaNCT02924402Xencor, Inc.154
终止
3 期
Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)ThrombosisCancerNCT00311896Clinica Universidad de Navarra, Universidad de Navarra402
终止
2 期
Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)Warm Autoimmune Hemolytic Anemia (wAIHA)NCT04661033Sanofi8
已完成
3 期
A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing SpondylitisSpondylitis, AnkylosingNCT00265083Centocor, Inc.356