NCT06877611招募中1 期
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-4321 in Healthy Volunteers
Seismic Therapeutic AU Pty Ltd1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年4月3日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.
详细描述
This is a randomized, placebo-controlled, double-blind, study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of S-4321 administered to healthy adult participants. This study will be conducted in two parts, Part 1 (single ascending dose, SAD) and Part 2 (multiple ascending doses, MAD).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is available for the entire duration of the study and follow up.
- •Is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
- •Voluntarily consents to participation in the trial as documented by signing the study informed consent form (ICF).
- •Has a body mass index (BMI) within 18 to 32 kg/m2, inclusive, and weighs ≥45 kg.
- •Is in good physical and mental health in the opinion of the Investigator or delegate.
排除标准
- •Has a history of severe allergic or anaphylactic reaction as determined by the Investigator or delegate.
- •Is pregnant, nursing, or is planning to become pregnant or breastfeed during the trial.
- •Has a known immunodeficiency disorder.
- •Has a history of malignancy or confirmed cervical dysplasia.
- •Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.
- •Has positive laboratory evidence for active hepatitis at screening.
- •Has any other condition or prior therapy that, in the opinion of the Investigator or delegate, may potentially compromise the safety or compliance of the participant, or may preclude the participant from successfully completing the study.
- •Other inclusion/exclusion eligibility criteria apply.
研究组 & 干预措施
S-4321 Part 1: Single ascending dose (SAD) cohorts
Experimental
干预措施: S-4321 (Drug)
S-4321 Part 1: Single ascending dose (SAD) cohorts
Experimental
干预措施: Placebo (Other)
S-4321 Part 2: Multiple ascending dose (MAD) cohorts
Experimental
干预措施: S-4321 (Drug)
S-4321 Part 2: Multiple ascending dose (MAD) cohorts
Experimental
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0
时间窗: 2 months
次要结局
- To assess the maximum serum concentration (CMAX)(2 months)
- To assess time to reach maximum serum concentration (tMAX)(2 months)
- To assess elimination half-life (t1/2)(2 months)
- To assess area under the serum concentration-time curve from time 0 to t hours (AUC0-t) and to infinity (AUC0-inf)(2 months)
- To assess clearance (CL)(2 months)
- To assess volume of distribution (Vz) and steady-state volume of distribution (Vss)(2 months)
- To assess bioavailability after SC administration (F%)(2 months)
- To characterize absolute change from baseline of Receptor Occupancy (RO) at multiple timepoints(2 months)
- Incidence and characterization of anti-drug antibody (ADA)(2 months)
研究者
研究点 (1)
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