STAR-0215 for Hereditary Angioedema

Phase 1 & 2

Waitlist Available

Research Sponsored by Astria Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented diagnosis of HAE (type I or II) with documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria)

Be older than 18 years old

Must not have

Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cohort 1: day 1 (pre-dose); days 14, 28, 56, 84, 112, 140, and 168; cohort 2: days 1 and 84 (pre-dose); days 14, 28, 56, 111, 167, and 251; cohort 3: days 1 and 28 (pre-dose); days 14, 55, 111, and 195

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a new drug, STAR-0215, on people with hereditary angioedema. Some will get 1 dose, some 2, to see which works best.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is the first time STAR-0215 is being given to participants with HAE, specific side effects are unknown but may be similar to those of other treatments for HAE which can include reactions at injection site, headache, fatigue, nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cohort 1: day 1 (pre-dose); days 14, 28, 56, 84, 112, 140, and 168; cohort 2: days 1 and 84 (pre-dose); days 14, 28, 56, 111, 167, and 251; cohort 3: days 1 and 28 (pre-dose); days 14, 55, 111, and 195

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cohort 1: day 1 (pre-dose); days 14, 28, 56, 84, 112, 140, and 168; cohort 2: days 1 and 84 (pre-dose); days 14, 28, 56, 111, 167, and 251; cohort 3: days 1 and 28 (pre-dose); days 14, 55, 111, and 195

This trial's timeline: 3 weeks for screening, Varies for treatment, and cohort 1: day 1 (pre-dose); days 14, 28, 56, 84, 112, 140, and 168; cohort 2: days 1 and 84 (pre-dose); days 14, 28, 56, 111, 167, and 251; cohort 3: days 1 and 28 (pre-dose); days 14, 55, 111, and 195 for reporting.