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Clinical Trial NCT07245368 for Mild to Moderate Asthma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma Phase 1, Phase 2 96 Randomized Double-Blind Placebo-Controlled
Clinical Trial NCT07245368 is designed to study Treatment for Mild to Moderate Asthma. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 4 November 2025, with plans to enroll 96 participants. Led by Prana Therapies Inc, it is expected to complete by 31 January 2027. The latest data from ClinicalTrials.gov was last updated on 20 March 2026.
Brief Summary
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 ...
Detailed Description
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 b...
Show MoreOfficial Title
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
Conditions
Mild to Moderate AsthmaOther Study IDs
- PRA-216-101
NCT ID Number
Start Date (Actual)
2025-11-04
Last Update Posted
2026-03-20
Completion Date (Estimated)
2027-01-31
Enrollment (Estimated)
96
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Keywords
healthy volunteers
pharmacodynamics
immunogenicity
asthma
pharmacokinetics
pharmacodynamics
immunogenicity
asthma
pharmacokinetics
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPhase 1, Part 1: SAD Cohorts: Active Drug Healthy volunteers will receive a single dose of PRA-216 in a dose escalation format. | PRA-216 biologic |
Placebo ComparatorPhase 1, Part 1: SAD Cohorts: Placebo Healthy volunteers will receive a single dose of placebo | Placebo matching placebo for PRA-216 |
ExperimentalPhase 1, Part 2: MAD Cohort: Active Drug Healthy volunteers will receive repeated doses of PRA-216 in a dose escalation format. | PRA-216 biologic |
Placebo ComparatorPhase 1, Part 2 MAD Cohort: Placebo Comparator Healthy volunteers will receive repeated doses of placebo comparator. | Placebo matching placebo for PRA-216 |
ExperimentalPhase 2a: Participants with mild to moderate asthma-active drug Participants with mild to moderate asthma will be randomized to receive repeat doses of PRA-216. | PRA-216 biologic |
Placebo ComparatorPhase 2a: Participants with mild to moderate asthma-placebo Participants with mild to moderate asthma will be randomized to receive repeat doses of placebo. | Placebo matching placebo for PRA-216 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) | 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) | 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. | Up to Study Day 57 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | 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 | 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 | 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. | 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) | 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 | 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 | 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 | 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 | Up to Study Day 197 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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
- 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 ≥ 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 ≥ 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 ≥10 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
Prana Therapies IncStudy Central Contact
Contact: Linear site contact, +61 (0)8 6382 5110, [email protected]
7 Study Locations in 2 Countries
New South Wales
Emertitus Research Sydney, Botany, New South Wales, 2019, Australia
Ronald Mak, MD, Contact, 0289648186, [email protected]
Not yet recruiting
Victoria
Emeritus Research Camberwell, Camberwell, Victoria, 3124, Australia
Sam Francis, MD, Contact, 0395096166, [email protected]
Not yet recruiting
Western Australia
Linear, Joondalup, Western Australia, 6027, Australia
Contact, 011 61 88 6382 5110, [email protected]
Not yet recruiting
Linear, Nedlands, Western Australia, 6009, Australia
site contact, Contact, 08 6382 5110, [email protected]
Recruiting
Auckland
PCRN Waikato, Nawton, Hamilton, Auckland, 3200, New Zealand
Enrollment Coordinator, Contact, +64 07 960 2123, [email protected]
Not yet recruiting
Pacific Clinical Research Network-Auckland, Takapuna, Auckland, 0622, New Zealand
Enrollment Coordinator, Contact, +64 9 242 3321, [email protected]
Contact, [email protected]
Not yet recruiting
PCRN Wellington, Ebdentown, Upper Hutt, Auckland, 5018, New Zealand
Enrollment Coordinator, Contact, +64 4 9201800, [email protected]
Not yet recruiting