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ARS-1 1mg for Hives

Phase 2
Waitlist Available
Research Sponsored by ARS Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessment will start from 1 hour pre-dose to 120 (± 10 min) minutes after dosing.
Awards & highlights

Study Summary

This trial will look at whether ARS-1 can reduce the itchiness and hives that some patients report.

Who is the study for?
Adults aged 18-65 with a body weight over 30 kg and BMI of 18-34, who experience frequent hives at least twice weekly despite chronic treatment. They must not have significant health issues like heart disease or hypertension in the past decade, no recent major injuries or surgeries, and agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing ARS-1, an intranasal medication for reducing itchiness and hive severity in people with urticaria (hives). Participants will either receive ARS-1 or a placebo to compare outcomes. The main goal is to see how well ARS-1 improves patients' symptoms.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions related to nasal administration such as irritation or discomfort. Given that epinephrine is involved, there might also be systemic effects like palpitations or anxiety.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessment will start from 1 hour pre-dose to 120 (± 10 min) minutes after dosing.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessment will start from 1 hour pre-dose to 120 (± 10 min) minutes after dosing. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of ARS-1 versus placebo based on a patient reported pruritus/hive score

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: ARS-1 1mgActive Control1 Intervention
1 mg per 100 µL dose of ARS-1
Group II: ARS-1 2mgActive Control1 Intervention
2 mg per 100 µL dose of ARS-1
Group III: PlaceboPlacebo Group1 Intervention
Placebo (100 µL)

Find a Location

Who is running the clinical trial?

ARS Pharmaceuticals, Inc.Lead Sponsor
2 Previous Clinical Trials
45 Total Patients Enrolled
Sarina Tanimoto, MD, PhDStudy DirectorARS Pharmaceuticals, Inc.
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares
2022. "Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05496465.
~12 spots leftby Apr 2025
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