Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Recruiting · NCT07245368 · Interventional (participants receive a specific treatment) · Lead sponsor: Prana Therapies Inc
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
8 locations listed.
- PCRN Waikato, Nawton - Hamilton, Auckland, New Zealand
- Pacific Clinical Research Network-Auckland - Takapuna, Auckland, New Zealand
- PCRN Wellington, Ebdentown - Upper Hutt, Auckland, New Zealand
- Emertitus Research Sydney - Botany, New South Wales, Australia
- Emeritus Research Camberwell - Camberwell, Victoria, Australia
- Monash Health - Clayton, Victoria, Australia
- Linear - Joondalup, Western Australia, Australia
- Linear - Nedlands, Western Australia, Australia