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
This trial accepts healthy volunteersQualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PRA-216
Drugbiologic
Placebo
Drugmatching placebo for PRA-216
Treatment groups
96 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Phase 1, Part 1: SAD Cohorts: Active DrugExperimental treatment 1 intervention
Group B: Phase 1, Part 1: SAD Cohorts: PlaceboPlacebo comparator 1 intervention
Group C: Phase 1, Part 2: MAD Cohort: Active DrugExperimental treatment 1 intervention
Group D: Phase 1, Part 2 MAD Cohort: Placebo ComparatorPlacebo comparator 1 intervention
Group E: Phase 2a: Participants with mild to moderate asthma-active drugExperimental treatment 1 intervention
Group F: Phase 2a: Participants with mild to moderate asthma-placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) with a single dose of PRA-216 in healthy volunteers (SAD arm)
Incidence, nature, and severity of serious adverse events (SAEs)
Time frame
Up to Study Day 1692
Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) of multiple doses of PRA-216 in healthy volunteers (MAD arm)
Incidence, nature, and severity of and serious adverse events (SAEs)
Time frame
up to Study Day 1693
Phase 2a: To evaluate the effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in asthma participants
Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker of airway inflammation in asthma.
Time frame
Up to Study Day 57Secondary outcomes
1
Phase 1: Immunogenicity of PRA-216: ADA in healthy volunteers
Incidence and magnitude of anti-drug antibody following single or multiple doses of PRA-216
Time frame
Up to Study Day 1692
Phase 1: Pharmacokinetics of PRA-216: Tmax in healthy volunteers
Time to maximum concentration of drug in plasma following single or multiple doses of PRA-216
Time frame
Up to Study Day 1693
Phase 1: Pharmacokinetics of PRA-216: AUC in healthy volunteers
Area under the curve following single or multiple doses of PRA-216
Time frame
Up to Study Day 1694
Phase 1: Pharmacokinetics of PRA-216: Cmax in healthy volunteers
Maximum concentration of PRA-216 in plasma following single or multiple doses of PRA-216.
Time frame
Up to Study Day 169Sponsors and contacts
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Source ClinicalTrials.gov