NCT07245368RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 4 Nov 2025
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Prana Therapies Inc
- Diseases
- Asthma
- NCT number
- NCT07245368
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 96
- From 4 Nov 2025 to the primary completion date, 1 Oct 2026
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Criteria the registry did not label
- Phase 1
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emertitus Research Sydney Coordinator of this site? Confirm its status | Botany | Australia | Recruiting |
| Emeritus Research Camberwell Coordinator of this site? Confirm its status | Camberwell | Australia | Recruiting |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Not yet recruiting |
| Linear Coordinator of this site? Confirm its status | Joondalup | Australia | Recruiting |
| Linear Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| PCRN Waikato, Nawton Coordinator of this site? Confirm its status | Hamilton | New Zealand | Recruiting |
| Pacific Clinical Research Network Auckland Coordinator of this site? Confirm its status | Takapuna | New Zealand | Recruiting |
| PCRN Wellington, Ebdentown Coordinator of this site? Confirm its status | Upper Hutt | New Zealand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.