Evaluating STAR-0310 in healthy adults
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
This study is testing a new treatment called STAR-0310 in healthy adults to see how safe it is and how it works in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Astria Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT06782477 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled trial assessing the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in healthy adult participants. The study includes four planned cohorts, with the possibility of an additional cohort specifically for healthy adults of Japanese descent. Participants will receive either the STAR-0310 treatment or a placebo in a single ascending dose format. The trial aims to gather important data on how the drug interacts with healthy individuals.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 35 with a BMI between 18 and 35 kg/m2.
Not a fit: Patients with prior medical conditions that could affect their safety or those with known sensitivities to STAR-0310 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and tolerability of STAR-0310, paving the way for future therapeutic applications.
How similar studies have performed: While this approach is common in early-phase trials, the specific drug STAR-0310 has not been previously tested in this manner.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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
Where this trial is running
Austin, Texas
- Austin Clinical Research Unit - Early Clinical Development — Austin, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Claire VanEenwyk, MD
- Email: STAR-0310program@Astriatx.com
- Phone: 1-617-349-1971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.