* 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) with a single dose of PRA-216 in healthy volunteers (SAD arm) — Up to Study Day 169 Incidence, nature, and severity of serious adverse events (SAEs)
Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) of multiple doses of PRA-216 in healthy volunteers (MAD arm) — up to Study Day 169 Incidence, nature, and severity of and serious adverse events (SAEs)
Phase 2a: To evaluate the effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in asthma participants — Up to Study Day 57 Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker of airway inflammation in asthma.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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