NCT07557355
尚未招募
1 期
A Phase 1/2a, Randomized, Double Blind, Placebo Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SRSD384 in Overweight or Obese Participants
Sirius Therapeutics Co., Ltd.0 个研究点目标入组 78 人开始时间: 2026年6月1日最近更新:
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Sirius Therapeutics Co., Ltd.
- 入组人数
- 78
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
概览
简要总结
This is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD384 alone in overweight or obese participants (Part A) and in combination with tirzepatide in overweight or obese participants with T2DM (Part B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions;
- •Males or females;
- •Body mass index (BMI) between 27.0 and 40.0 kg/m2, inclusive;
- •Male subjects are not allowed to donate sperm, and female subjects are not allowed to donate eggs from the time the ICF is signed until at least 3 months after the last follow-up.
排除标准
- •Obesity attributable, in the investigator's opinion, to medication use, endocrinologic or monogenic disorders;
- •Having a significant medical history or clinical manifestations related to any allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine (other than overweight or obesity), or psychiatric conditions that are severe or unstable (determined by the investigator or medically qualified designee);
- •Evidence of active cancer within 2 years prior to screening (non-melanoma skin cancer, localized prostate cancer treated with curative intent, or other in situ carcinoma that does not require systemic therapy and is considered cured for at least 1 year is allowed);
- •Acute febrile illness within 7 days prior to randomization or evidence of active infection
- •Any major surgery within 3 months prior to screening or plan to have any major surgery during the study;
- •History of clinically significant hypersensitivity, intolerance, or allergy to any oligonucleotide or GalNAc as determined by the investigator;
- •Receipt of an investigational drug within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study;
- •Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216.
研究组 & 干预措施
SRSD384 injection (Part B)
Experimental
干预措施: SRSD384 injection (Drug)
0.9% Sodium Chloride (Part B)
Placebo Comparator
干预措施: Placebo (Drug)
SRSD384 injection (Part A)
Experimental
干预措施: SRSD384 injection (Drug)
0.9% Sodium Chloride (Part A)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: 168 days
次要结局
- Maximal concentration of SRSD384(48 hours)
- Area under the concentration-time curve from time 0 to infinity of SRSD384(48 hours)
- Time to the maximal concentration of SRSD384(48 hours)
研究者
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