STAR-0215 for Hereditary Angioedema

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Astria Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to test the drug STAR-0215 in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of STAR-0215, and two other groups will get 2 doses of STAR-0215. Researchers will study the effects of STAR-0215 in participants with HAE as this is the first time that the drug has been given to participants with HAE.

Eligibility Criteria

This trial is for people with hereditary angioedema (HAE) types I or II who have had at least two HAE attacks during the run-in period. Participants must not have used certain medications like ACE inhibitors, estrogen, androgens, or preventive HAE therapies within specified time frames before screening.

Inclusion Criteria

I have been diagnosed with HAE and have a history of swelling episodes without hives.

You had at least 2 HAE attacks confirmed by a doctor during the initial period of the study.

Exclusion Criteria

I haven't taken ACE inhibitors or estrogen medications in the last 28 days.

I haven't taken HAE prevention drugs like lanadelumab, berotralstat, or others recently.

I have not taken any androgen medications in the last 7 days.

+1 more

Participant Groups

The study tests STAR-0215 in individuals with hereditary angioedema. It involves one group receiving a single dose of STAR-0215 and two other groups getting two doses to evaluate the drug's effects on HAE patients.

3Treatment groups

Experimental Treatment

Group I: Cohort 3 - Multiple DoseExperimental Treatment1 Intervention

Participants will receive 2 doses of STAR-0215 administered 1 month apart.

Group II: Cohort 2 - Multiple DoseExperimental Treatment1 Intervention

Participants will receive 2 doses of STAR-0215 administered 3 months apart.

Group III: Cohort 1 - Single DoseExperimental Treatment1 Intervention

Participants will receive 1 dose of STAR-0215.