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Clinical Trials in Australia / NCT07245368
Recruiting Phase 1/2

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

NCT07245368 · tracked via the Priya Life Science Australia tracker
Sponsor
Prana Therapies Inc
Phase
Phase 1/2
Started
2025-11-04
Last updated
2026-08-06

Condition(s) studied

Mild to Moderate Asthma

Investigational drug(s) / intervention(s)

PRA-216Placebo

PRA-216: biologic

Placebo: matching placebo for PRA-216

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Phase 1 Inclusion Criteria: * Age 18-65 * Must be in good health with no significant medical history * Willing and able to attend all study visits, comply with study requirements * Able and willing to provide written informed consent Exclusion Criteria: * Evidence of clinically significant condition or disease * Any physical or psychological condition that prohibits study completion * Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent * History of severe allergic reactions or hypersensitivity * Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing Phase 2a Inclusion criteria: * Age 18-65 * Must be in good health with no significant medical history * Willing and able to attend all study visits, comply with study requirements. * Able and willing to provide written informed consent * Documented asthma diagnosis prior for at least 12 months prior to screening. * Symptomatic asthma * Currently receiving maintenance asthma medications Exclusion Criteria: * Evidence of clinically significant condition or disease * Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent * Donation or loss of ≥ 1 unit of whole blood or plasma within 2 months prior to dosing * History of severe allergic reactions or hypersensitivity * Current or former smoker with a smoking history of ≥10 pack-years * Receipt of immunosuppressant therapies or biologic therapy for asthma within 6 months of screening * Other investigational agent(s) within 30 days of dosing

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Emertitus Research Sydney Botany New South Wales Recruiting
Emeritus Research Camberwell Camberwell Victoria Recruiting
Monash Health Clayton Victoria Not Yet Recruiting
Linear Joondalup Western Australia Recruiting
Linear Nedlands Western Australia Recruiting
PCRN Waikato, Nawton Hamilton Auckland Recruiting
Pacific Clinical Research Network-Auckland Takapuna Auckland Recruiting
PCRN Wellington, Ebdentown Upper Hutt Auckland Recruiting

More Prana Therapies Inc trials in Australia

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07245368 on ClinicalTrials.gov ↗ ← All trials in Australia