A Phase 1/2 interventional study of PRA-216 and Placebo in Mild to Moderate Asthma, sponsored by Prana Therapies Inc. Recruiting at 8 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Prana Therapies Inc · Phase 1/2, Interventional, and Treatment
Phase 1 of this study will consist of 2 parts
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.
This study is a Phase 1/2a randomized, double-blind, placebo-controlled, single- and multiple-dose study with staggered dose escalations in healthy participants and participants with mild to moderate asthma. Single-ascending dose (SAD) cohorts will be evaluated for one single dose administered. Multiple ascending dose (MAD) cohorts will be evaluated for repeat doses .
Participants with mild to moderate asthma will be recruited for Phase 2a of this study, to evaluate safety of randomized, double blind, placebo controlled PRA-216. The dose of PRA-216 for this phase was determined from Phase 1 safety, tolerability, and PK data. Additional dose levels or schedules may be used for Phase 2a, depending on data from Phase 1.
This study consists of 2 phases, as follows:
Phase 1, Part 1:
SAD in healthy volunteers. Study visits in this section will entail a single dose administration of PRA-216 or placebo and collection of study data.
Phase 1, Part 2:
MAD in healthy volunteers. Study visits in this section will entail repeat doses of PRA-216 or placebo and collection of study data.
Phase 2a Participants with mild to moderate asthma will receive PRA-216 or placebo.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 96 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Prana Therapies Inc is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Phase 1
Inclusion Criteria:
Exclusion Criteria:
Phase 2a
Inclusion criteria:
Exclusion Criteria:
Healthy volunteers will receive a single dose of PRA-216 in a dose escalation format.
Drug: PRA-216
Healthy volunteers will receive a single dose of placebo
Drug: Placebo
Healthy volunteers will receive repeated doses of PRA-216 in a dose escalation format.
Drug: PRA-216
Healthy volunteers will receive repeated doses of placebo comparator.
Drug: Placebo
Participants with mild to moderate asthma will be randomized to receive repeat doses of PRA-216.
Drug: PRA-216
Participants with mild to moderate asthma will be randomized to receive repeat doses of placebo.
Drug: Placebo
biologic
matching placebo for PRA-216
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 169
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 169
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 57
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 169
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 169
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 169
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 169
Phase 2a: Incidence, nature, and severity of serious adverse events (SAEs) of PRA-216 in patients with asthma
Incidence, nature, and severity of serious adverse events (SAEs)
Time frame: Up to Study Day 197
Phase 2a: Immunogenicity of PRA-216: ADA in patients with asthma
Incidence and magnitude of anti-drug antibody following drug administration
Time frame: Up to Study Day 197
Phase 2a: Pharmacokinetics of PRA-216: Tmax in patients with asthma
Time to maximum concentration of drug in plasma following multiple doses of PRA-216
Time frame: Up to Study Day 197
Phase 2a: Pharmacokinetics of PRA-216: AUC in patients with asthma
Area under the curve of PRA-216 following multiple doses of PRA-216
Time frame: Up to Study Day 197
Phase 2a: Pharmacokinetics of PRA-216: Cmax in patients with asthma
Maximum concentration in plasma of PRA-216 following multiple doses
Time frame: Up to Study Day 197
Plan to share: No
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Prana Therapies Inc