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

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 will be determined from Phase 1.

Eligibility

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

Conditions2

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