Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma

ConditionMild to Moderate Asthma

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorPrana Therapies Inc

About this trial

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

Qualifiers

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

Disqualifiers

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