Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Recruiting now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Mild to Moderate Asthma
In brief
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.
Key facts
- Study ID
- NCT07245368
- Run by
- Prana Therapies Inc
- People needed
- 96
- Starts
- 2025-11-04
- Expected to finish
- 2027-01-31
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- PCRN Wellington, Ebdentown — Upper Hutt, Auckland, New Zealand (enrolling)
- Emeritus Research Camberwell — Camberwell, Victoria, Australia (enrolling)
- Emertitus Research Sydney — Botany, New South Wales, Australia (enrolling)
- Linear — Joondalup, Western Australia, Australia (enrolling)
- Linear — Nedlands, Western Australia, Australia (enrolling)
- PCRN Waikato, Nawton — Hamilton, Auckland, New Zealand (enrolling)
- Pacific Clinical Research Network-Auckland — Takapuna, Auckland, New Zealand (enrolling)
- Monash Health — Clayton, Victoria, Australia
Full record on ClinicalTrials.gov
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