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Monoclonal Antibodies

STAR-0215 Dose 1 for Hereditary Angioedema

Phase 1
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-dose, up to 2 hours before study drug administration); days 28, 56, 84, 112, 140, 168, 196, and 224
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in humans. It is being done in a small group of people and is double-blind, meaning that neither the participants nor the researchers know who is receiving the drug or the placebo.

Eligible Conditions
  • Hereditary Angioedema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-dose, up to 2 hours before study drug administration, and 2, 6, 12, 24, 48, 72, 96, and 120 hours post-dose); days 14, 28, 56, 84, 112, 140, 168, 196, and 224
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (pre-dose, up to 2 hours before study drug administration, and 2, 6, 12, 24, 48, 72, 96, and 120 hours post-dose); days 14, 28, 56, 84, 112, 140, 168, 196, and 224 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Number of Participants with Anti-drug Antibodies to STAR-0215
Plasma Levels of Cleaved High-molecular-weight Kininogen
Serum Concentration of STAR-0215

Trial Design

5Treatment groups
Experimental Treatment
Group I: STAR-0215 Dose 5Experimental Treatment2 Interventions
Participants will be randomized to receive STAR-0215 or placebo.
Group II: STAR-0215 Dose 4Experimental Treatment2 Interventions
Participants will be randomized to receive STAR-0215 or placebo.
Group III: STAR-0215 Dose 3Experimental Treatment2 Interventions
Participants will be randomized to receive STAR-0215 or placebo.
Group IV: STAR-0215 Dose 2Experimental Treatment2 Interventions
Participants will be randomized to receive STAR-0215 or placebo.
Group V: STAR-0215 Dose 1Experimental Treatment2 Interventions
Participants will be randomized to receive STAR-0215 or placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
STAR-0215 (SC)
2022
Completed Phase 1
~50
Placebo (SC)
2010
Completed Phase 3
~420
STAR-0215 (IV)
2022
Completed Phase 1
~50
Placebo (IV)
2015
Completed Phase 3
~800

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

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

Media Library

STAR-0215 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05477160 — Phase 1
Hereditary Angioedema Research Study Groups: STAR-0215 Dose 1, STAR-0215 Dose 2, STAR-0215 Dose 3, STAR-0215 Dose 4, STAR-0215 Dose 5
Hereditary Angioedema Clinical Trial 2023: STAR-0215 Highlights & Side Effects. Trial Name: NCT05477160 — Phase 1
STAR-0215 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05477160 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial include participants of advanced age?

"This medical study will include individuals that are over 18 years old and younger than 60."

Answered by AI

Is recruitment still open for this experiment?

"Affirmative. According to the clinicaltrials.gov repository, this investigation is actively recruiting individuals - having first been posted on July 27th 2022 and revised August 9th 2022. 24 volunteers are needed from 1 research centre in total."

Answered by AI

Who has been invited to take part in this experiment?

"The criteria for inclusion in this medical trial is that the participants must have hereditary angioedemas and be between 18-60 years old. There are 24 slots open to fill."

Answered by AI

What health hazards could potentially arise from ingesting STAR-0215?

"Considering the limited data indicating efficacy and safety, our team at Power scored STAR-0215 a 1 on their risk scale."

Answered by AI

How many individuals have been recruited to participate in this experiment?

"Affirmative. Clinicaltrials.gov hosts the information that this experiment, launched on July 27th 2022, is currently seeking qualifiers. The total amount of participants sought for this clinical trial stands at 24, who will be recruited from a single study site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of STAR-0215 in Healthy Adult Participants
2022. "A Study of STAR-0215 in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05477160.
~15 spots leftby Apr 2025
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