Actively Recruiting
Study of PRA-216 in Healthy Volunteers and Participants With Mild to Moderate Asthma A Phase 1 and Phase 2a Randomized, Double-Blind, Placebo-Controlled Study Evaluating Single and Multiple Doses of PRA-216
Led by Prana Therapies Inc · Updated on 2026-03-20
96
Participants Needed
7
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates PRA-216, a biologic drug, in both healthy volunteers and participants with mild to moderate asthma. It is a Phase 1/2a randomized, double-blind, placebo-controlled study designed to assess safety, tolerability, pharmacokinetics, immunogenicity, and efficacy. The study includes single and multiple ascending dose parts in healthy individuals and a Phase 2a portion to evaluate PRA-216 in asthma patients based on Phase 1 findings. Phase 1 consists of two parts: Part 1 (single ascending dose) administers one dose of PRA-216 or placebo intravenously or subcutaneously to healthy volunteers, while Part 2 (multiple ascending dose) gives repeat subcutaneous doses to healthy volunteers. Phase 2a enrolls participants with mild to moderate asthma who receive PRA-216 or placebo to assess the drug's effect on asthma symptoms and exhaled nitric oxide levels. Dosages and schedules in Phase 2a are informed by Phase 1 safety and pharmacokinetic data. Participants attend multiple visits for dosing and data collection throughout the study periods, including up to Study Day 169 for Phase 1 and Day 57 for Phase 2a. Researchers monitor serious adverse events, pharmacokinetics, immunogenicity, and asthma-related outcomes such as exhaled nitric oxide. Safety, tolerability, and effectiveness are evaluated, with participants providing informed consent and complying with study requirements across the study timeline.
CONDITIONS
Official Title
Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65
- Must be in good health with no significant medical history
- Willing and able to attend all study visits and comply with study requirements
- Able and willing to provide written informed consent
- For Phase 2a: Documented asthma diagnosis for at least 12 months prior to screening
- For Phase 2a: Symptomatic asthma
- For Phase 2a: Currently receiving maintenance asthma medications
You will not qualify if you...
- 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, alcoholism, or smoking/nicotine use within 3 months prior to first dose
- History of severe allergic reactions or hypersensitivity
- Donation or loss of 63 1 unit of whole blood or plasma within 2 months prior to dosing
- For Phase 2a: Current or former smoker with a smoking history of 65 10 pack-years
- For Phase 2a: Receipt of immunosuppressant therapies or biologic therapy for asthma within 6 months of screening
- For Phase 2a: Use of other investigational agents within 30 days of dosing
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Emertitus Research Sydney
Botany, New South Wales, Australia, 2019
Not Yet Recruiting
2
Emeritus Research Camberwell
Camberwell, Victoria, Australia, 3124
Not Yet Recruiting
3
Linear
Joondalup, Western Australia, Australia, 6027
Not Yet Recruiting
4
Linear
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
5
PCRN Waikato, Nawton
Hamilton, Auckland, New Zealand, 3200
Not Yet Recruiting
6
Pacific Clinical Research Network-Auckland
Takapuna, Auckland, New Zealand, 0622
Not Yet Recruiting
7
PCRN Wellington, Ebdentown
Upper Hutt, Auckland, New Zealand, 5018
Not Yet Recruiting
Research Team
L
Linear site contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Frequently Asked Questions
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