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 will be determined from Phase 1.
• 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