STAR-0215 for Angioedemas, Hereditary

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spaulding Clinical Research, LLC, West Bend, WI
Angioedemas, Hereditary+2 More
STAR-0215 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous administration of STAR-0215 in healthy adult participants.

Eligible Conditions

  • Angioedemas, Hereditary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Angioedemas, Hereditary

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 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

Day 28
Number of Participants with Anti-drug Antibodies to STAR-0215
Day 14
Plasma Levels of Cleaved High-molecular-weight Kininogen
Serum Concentration of STAR-0215
Day 224
Number of Participants Experiencing Treatment-emergent Adverse Events

Trial Safety

Safety Progress

1 of 3

Other trials for Angioedemas, Hereditary

Trial Design

3 Treatment Groups

STAR-0215 Dose 1
1 of 3
STAR-0215 Dose 2
1 of 3
STAR-0215 Dose 3
1 of 3
Experimental Treatment

24 Total Participants · 3 Treatment Groups

Primary Treatment: STAR-0215 · Has Placebo Group · Phase 1

STAR-0215 Dose 1Experimental Group · 2 Interventions: Placebo, STAR-0215 · Intervention Types: Drug, Drug
STAR-0215 Dose 2Experimental Group · 2 Interventions: Placebo, STAR-0215 · Intervention Types: Drug, Drug
STAR-0215 Dose 3Experimental Group · 2 Interventions: Placebo, STAR-0215 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
Closest Location: Spaulding Clinical Research, LLC · West Bend, WI
Photo of wisconsin 1Photo of wisconsin 2Photo of wisconsin 3
2009First Recorded Clinical Trial
1 TrialsResearching Angioedemas, Hereditary
12 CompletedClinical Trials

Who is running the clinical trial?

Astria Therapeutics, Inc.Lead Sponsor

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have good health as determined by the Investigator based upon a medical evaluation, including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory measurements.
Male participants must agree to use an effective method of contraception and abstain from sperm donation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.