A Study of STAR-0310 in Healthy Adult Participants

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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: STAR-0310; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • Austin Clinical Research Unit - Early Clinical Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STAR-0310 Dose 1; Participants will be randomized to receive STAR-0310 or matching placebo	Drug: STAR-0310; STAR-0310 will be administered as a subcutaneous bolus injection.; Drug: Placebo; Placebo will be administered as a subcutaneous bolus injection.
Experimental: STAR-0310 Dose 2; Participants will be randomized to receive STAR-0310 or matching placebo	Drug: STAR-0310; STAR-0310 will be administered as a subcutaneous bolus injection.; Drug: Placebo; Placebo will be administered as a subcutaneous bolus injection.
Experimental: STAR-0310 Dose 3; Participants will be randomized to receive STAR-0310 or matching placebo	Drug: STAR-0310; STAR-0310 will be administered as a subcutaneous bolus injection.; Drug: Placebo; Placebo will be administered as a subcutaneous bolus injection.
Experimental: STAR-0310 Dose 4; Participants will be randomized to receive STAR-0310 or matching placebo	Drug: STAR-0310; STAR-0310 will be administered as a subcutaneous bolus injection.; Drug: Placebo; Placebo will be administered as a subcutaneous bolus injection.
Experimental: STAR-0310 in Participants of Japanese Descent; Participants will be randomized to receive STAR-0310 or matching placebo	Drug: STAR-0310; STAR-0310 will be administered as a subcutaneous bolus injection.; Drug: Placebo; Placebo will be administered as a subcutaneous bolus injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Experiencing Treatment-emergent Adverse Events	[Time Frame: Day 1 through Day 252]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Concentration of STAR-0310	Blood samples will be collected to measure the serum concentration of STAR-0310 before and after study drug administration.	[Time Frame: Day 1 (predose up to 2 hours before study drug administration, and 12 hours post dose), Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 84, 112, 140, 168, 196, 224, 252 ]
Number of Participants with Anti-drug Antibodies to STAR-0310	Blood samples will be collected to assess the formation of STAR-0310 anti-drug antibodies in serum before and after study drug administration.	[Time Frame: Day 1 predose, Days 14, 28, 84, 168, 252 ]

Collaborators and Investigators

• Sponsor: Astria Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 31, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STAR-0310-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No