NCT07245368 Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma
| NCT ID | NCT07245368 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Prana Therapies Inc |
| Condition | Mild to Moderate Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 96 participants in total. It began in 2025-11-04 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07245368 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Mild to Moderate Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07245368 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07245368 currently recruiting?
Yes, NCT07245368 is actively recruiting participants. Contact the research team at enquiries@linear.org.au for enrollment information.
Where is the NCT07245368 trial being conducted?
This trial is being conducted at Botany, Australia, Camberwell, Australia, Joondalup, Australia, Nedlands, Australia and 3 additional locations.
Who is sponsoring the NCT07245368 clinical trial?
NCT07245368 is sponsored by Prana Therapies Inc. The trial plans to enroll 96 participants.
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