PRA-216 for healthy adults and adults 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
This trial will test whether PRA-216 is safe, how it behaves in the body, and whether it shows benefit in adults with mild-to-moderate asthma compared with placebo.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Prana Therapies Inc Industry-sponsored |
| Locations | 7 sites (Botany, New South Wales and 6 other locations) |
| Trial ID | NCT07245368 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2a study first gives single and then repeated ascending doses of PRA-216 to healthy adults to measure safety, tolerability, pharmacokinetics, and immunogenicity, using both intravenous and subcutaneous routes in Phase 1. Phase 2a is a randomized, double-blind, placebo-controlled portion that gives the selected Phase 1 dose to adults with mild-to-moderate asthma to collect additional safety, immunogenicity, pharmacokinetic, and preliminary efficacy data. Dose escalations are staggered and controlled, with close monitoring for adverse events and antibody responses. The trial uses placebo control and blinding in Phase 2a to compare outcomes robustly while early parts focus on determining a safe dose and schedule.
Who should consider this trial
Good fit: Ideal candidates are adults 18 to 65 with mild-to-moderate asthma (for Phase 2a) who are able and willing to attend study visits and meet the study's health and consent requirements.
Not a fit: Patients with severe asthma, significant medical comorbidities, recent blood donation, recent nicotine use, a history of severe allergic reactions, or those outside the 18–65 age range are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, PRA-216 could become a new treatment option that improves asthma control with a defined safety and dosing profile.
How similar studies have performed: Other biologic and immunomodulatory approaches have shown benefit in specific asthma subtypes, but PRA-216 itself is investigational and has not yet been proven effective in patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Phase 1 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 Exclusion Criteria: * 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 this trial is running
Botany, New South Wales and 6 other locations
- Emertitus Research Sydney — Botany, New South Wales, Australia (Not_yet_recruiting)
- Emeritus Research Camberwell — Camberwell, Victoria, Australia (Not_yet_recruiting)
- Linear — Joondalup, Western Australia, Australia (Not_yet_recruiting)
- Linear — Nedlands, Western Australia, Australia (Recruiting)
- PCRN Waikato, Nawton — Hamilton, Auckland, New Zealand (Not_yet_recruiting)
- Pacific Clinical Research Network-Auckland — Takapuna, Auckland, New Zealand (Not_yet_recruiting)
- PCRN Wellington, Ebdentown — Upper Hutt, Auckland, New Zealand (Not_yet_recruiting)
Study contacts
- Study coordinator: Linear site contact
- Email: enquiries@linear.org.au
- Phone: +61 (0)8 6382 5110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.