RecruitingPhase 1Phase 2NCT07245368

Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending and Multiple Ascending Dose Study Investigating PRA-216 in Healthy Volunteers Followed by a Phase 2a Randomized, Double-Blind, Placebo-Controlled Study in Participants With Mild-to-Moderate Asthma


Sponsor

Prana Therapies Inc

Enrollment

96 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Phase 1 of this study will consist of 2 parts * Part 1 will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 in healthy volunteers through single ascending dose administered by either intravenous (IV) or subcutaneous (SC). * Part 2 will evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of PRA-216 in healthy volunteers with repeat doses of multiple ascending dose administered subcutaneously. Phase 2a of this study is a randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and immunogenicity of PRA-216 in participants with mild to moderate asthma. The dose of PRA-216 for this phase was determined from Phase 1.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new investigational drug called PRA-216 — first in healthy volunteers to check safety, then in people with mild-to-moderate asthma to see if it is safe, tolerated, and shows early signs of helping reduce asthma symptoms. **You may be eligible if...** - Phase 1 (healthy volunteers): You are 18 to 65 years old with no significant health conditions - Phase 2 (asthma group): You have a confirmed diagnosis of mild-to-moderate asthma - You are willing to attend all required study visits - You are able to provide written informed consent **You may NOT be eligible if...** - You have any significant medical condition (for the healthy volunteer phase) - You have severe asthma or asthma requiring frequent emergency care - You smoke or have a significant smoking history - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPRA-216

biologic

DRUGPlacebo

matching placebo for PRA-216


Locations(7)

Emertitus Research Sydney

Botany, New South Wales, Australia

Emeritus Research Camberwell

Camberwell, Victoria, Australia

Linear

Joondalup, Western Australia, Australia

Linear

Nedlands, Western Australia, Australia

PCRN Waikato, Nawton

Hamilton, Auckland, New Zealand

Pacific Clinical Research Network-Auckland

Takapuna, Auckland, New Zealand

PCRN Wellington, Ebdentown

Upper Hutt, Auckland, New Zealand

View Full Details on ClinicalTrials.gov

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NCT07245368


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