A First-in-Human, Phase 1a, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STAR-0310 in Healthy Adult Participants

Astria Therapeutics, Inc.1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2025年1月7日最近更新: 2025年11月4日

干预措施

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Astria Therapeutics, Inc.
入组人数: 40
试验地点: 1
主要终点: Number of Participants Experiencing Treatment-emergent Adverse Events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized, double-blind, placebo-controlled, single ascending dose trial evaluating the safety, tolerability, PK, and immunogenicity of STAR-0310 in healthy adult participants. There are 4 planned cohorts and potentially up to 1 additional cohort which may comprise of healthy adult participants of Japanese descent.

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 60 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Good health as determined by the Investigator based upon a medical evaluation.
•Body mass index (BMI) of 18 to 35 kg/m2 with a weight of at least 60 kg for men and at least 50 kg for women, with a maximum weight of 130 kg for any participant.
•Participants of childbearing potential must have a negative serum pregnancy test at Screening, agree to use highly effective forms of contraception and abstain from egg donation or fertility treatment
•Participants capable of producing sperm must use an effective method of contraception and abstain from sperm donation
•Healthy adults of Japanese descent, where both biological parents and all 4 biological grandparents are of Japanese ethnicity (applicable only for potential cohort of participants of Japanese descent).

排除标准

•Prior or ongoing medical condition that, in the Investigator's opinion, could adversely affect the safety of the participant.
•Known sensitivity to the ingredients of STAR-0310
•Taking any prescription or non-prescription medications within at least 5 half-lives or 7 days, whichever is longer, before the time of admission
•History of exposure to any biologic medication within 90 days or 5 half-lives, whichever is longer, before the time of admission
•Participation in a clinical trial involving receipt of an investigational product within 30 days (small molecule) or 90 days (biologics), or 5 half-lives, whichever is longer, before the time of admission