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Monoclonal Antibodies

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

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 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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Duration of HAE Attacks
Number of Participants with Anti-drug Antibodies To STAR-0215
Plasma Levels of Cleaved High-molecular-weight Kininogen
+2 more

Trial Design

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.

Find a Location

Who is running the clinical trial?

Astria Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
97 Total Patients Enrolled

Media Library

STAR-0215 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05695248 — Phase 1 & 2
Hereditary Angioedema Research Study Groups: Cohort 1 - Single Dose, Cohort 2 - Multiple Dose, Cohort 3 - Multiple Dose
Hereditary Angioedema Clinical Trial 2023: STAR-0215 Highlights & Side Effects. Trial Name: NCT05695248 — Phase 1 & 2
STAR-0215 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695248 — Phase 1 & 2
~10 spots leftby Sep 2025
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