PRA-216 for mild-to-moderate asthma, tested in healthy volunteers and people with asthma
Tests PRA-216 in healthy volunteers, then in adults with mild-to-moderate asthma.
Plain-language title generated from the registry record
Registry title: Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Key facts
- Where
- Botany, Camberwell, Clayton, Joondalup, and Nedlands, AustraliaSee the 5 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07245368, who can take part
Where in Australia
- Emertitus Research SydneyBotany, AustraliaTaking people
- Emeritus Research CamberwellCamberwell, AustraliaTaking people
- Monash HealthClayton, AustraliaNot yet recruiting
- LinearJoondalup, AustraliaTaking people
- LinearNedlands, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Prana Therapies Inc
- Trial code
- NCT07245368
- Record updated
- 6 August 2026
- Original description
Phase 1 of this study will consist of 2 partsRead full original descriptionShow less
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
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.
Inclusion: 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; 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: 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; Phase 2a; 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; Receipt of immunosuppressant therapies or biologic therapy for asthma within 6 months of screening; Other investigational agent(s) within 30 days of dosing; Evidence of clinically significant condition or disease; Any physical or psychological condition that prohibits study completion; History of severe allergic reactions or hypersensitivity; Evidence of clinically significant condition or disease; History of severe allergic reactions or hypersensitivity; Current or former smoker with a smoking history of ≥10 pack-years.
Phase 1.