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

RecruitingPhase 1, Phase 2Ages 18 Years - 65 YearsAllPrana Therapies Inc
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ฅ 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 โ‰ฅ10 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
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What it tests

  • PRA-216
  • Placebo
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Where

8 sites
Emertitus Research Sydney
Botany, Australia
Emeritus Research Camberwell
Camberwell, Australia
Monash Health
Clayton, Australia
Linear
Joondalup, Australia
Linear
Nedlands, Australia
PCRN Waikato, Nawton
Hamilton, New Zealand
Pacific Clinical Research Network-Auckland
Takapuna, New Zealand
PCRN Wellington, Ebdentown
Upper Hutt, New Zealand
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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