Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07245368
PHASE1/PHASE2

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

Sponsor: Prana Therapies Inc

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2025-11-04

Completion Date

2027-01-31

Last Updated

2026-03-20

Healthy Volunteers

Yes

Interventions

DRUG

PRA-216

biologic

DRUG

Placebo

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