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Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Sponsor: Prana Therapies Inc
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
Conditions
Interventions
PRA-216
biologic
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