NCT07245368

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Prana Therapies Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a Phase 1/2a randomized, double-blind, placebo-controlled, single- and multiple-dose study with staggered dose escalations in healthy participants and participants with mild to moderate asthma. Single-ascending dose (SAD) cohorts will be evaluated for one single dose administered. Multiple ascending dose (MAD) cohorts will be evaluated for repeat doses . Participants with mild to moderate asthma will be recruited for Phase 2a of this study, to evaluate safety of randomized, double blind, placebo controlled PRA-216. The dose of PRA-216 for this phase was determined from Phase 1 safety, tolerability, and PK data. Additional dose levels or schedules may be used for Phase 2a, depending on data from Phase 1. This study consists of 2 phases, as follows: Phase 1, Part 1: SAD in healthy volunteers. Study visits in this section will entail a single dose administration of PRA-216 or placebo and collection of study data. Phase 1, Part 2: MAD in healthy volunteers. Study visits in this section will entail repeat doses of PRA-216 or placebo and collection of study data. Phase 2a Participants with mild to moderate asthma will receive PRA-216 or placebo.

Conditions

• Mild to Moderate Asthma

Interventions

Type	Name	Description
DRUG	PRA-216	biologic
DRUG	Placebo	matching placebo for PRA-216

Timeline

• Start date: 2025-11-04
• Primary completion: 2026-10-01
• Completion: 2027-01-31
• First posted: 2025-11-24
• Last updated: 2026-03-20

Locations

7 sites across 2 countries: Australia, New Zealand