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NCT07245368RecruitingPhase 1/2

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

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending and Multiple Ascending Dose Study Investigating PRA-216 in Healthy Volunteers Followed by a Phase 2a Randomized, Double-Blind, Placebo-Controlled Study in Participants With Mild-to-Moderate Asthma

Source: ClinicalTrials.gov · Last updated 6 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
96 (estimated)
First submitted
17 Nov 2025
Start date
4 Nov 2025
Primary completion date
1 Oct 2026
Lead sponsor
Prana Therapies Inc
Diseases
Asthma
NCT number
NCT07245368

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 96
  • From 4 Nov 2025 to the primary completion date, 1 Oct 2026
  • 8 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
    • Phase 2a
  • 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
  • Receipt of immunosuppressant therapies or biologic therapy for asthma within 6 months of screening
  • Other investigational agent(s) within 30 days of dosing

Other illness

  • Evidence of clinically significant condition or disease
  • Any physical or psychological condition that prohibits study completion
  • History of severe allergic reactions or hypersensitivity
  • Evidence of clinically significant condition or disease
  • History of severe allergic reactions or hypersensitivity
  • Current or former smoker with a smoking history of ≥10 pack-years

Who the study is looking for

  • 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
  • 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

Criteria the registry did not label

  • Phase 1

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emertitus Research Sydney
Coordinator of this site? Confirm its status
BotanyAustraliaRecruiting
Emeritus Research Camberwell
Coordinator of this site? Confirm its status
CamberwellAustraliaRecruiting
Monash Health
Coordinator of this site? Confirm its status
ClaytonAustraliaNot yet recruiting
Linear
Coordinator of this site? Confirm its status
JoondalupAustraliaRecruiting
Linear
Coordinator of this site? Confirm its status
NedlandsAustraliaRecruiting
PCRN Waikato, Nawton
Coordinator of this site? Confirm its status
HamiltonNew ZealandRecruiting
Pacific Clinical Research Network Auckland
Coordinator of this site? Confirm its status
TakapunaNew ZealandRecruiting
PCRN Wellington, Ebdentown
Coordinator of this site? Confirm its status
Upper HuttNew ZealandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.