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

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.

Study Overview

• Status: Recruiting
• Conditions: Mild to Moderate Asthma
• Intervention / Treatment: Drug: PRA-216; Drug: Placebo

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Linear site contact; Phone Number: +61 (0)8 6382 5110; Email: enquiries@linear.org.au

Study Locations

• Australia
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • Not yet recruiting
      • Emertitus Research Sydney
      • Contact: Ronald Mak, MD; Phone Number: 0289648186; Email: ronaldmak@emeritusresearch.com
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Not yet recruiting
      • Emeritus Research Camberwell
      • Contact: Sam Francis, MD; Phone Number: 0395096166; Email: samfrancis@emeritusresearch.com
  • Western Australia
    • Joondalup, Western Australia, Australia, 6027
      • Not yet recruiting
      • Linear
      • Contact: Phone Number: 011 61 88 6382 5110; Email: enquiries@linear.org.au
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Linear
      • Contact: site contact; Phone Number: 08 6382 5110; Email: enquiries@linear.org.au
• New Zealand
  • Auckland
    • Hamilton, Auckland, New Zealand, 3200
      • Not yet recruiting
      • PCRN Waikato, Nawton
      • Contact: Enrollment Coordinator; Phone Number: +64 07 960 2123; Email: enquiries@clinicaltrialswaikato.co.nz
    • Takapuna, Auckland, New Zealand, 0622
      • Not yet recruiting
      • Pacific Clinical Research Network-Auckland
      • Contact: Enrollment Coordinator; Phone Number: +64 9 242 3321; Email: Adminauckland@pcrn.co.nz
      • Contact: Email: Auckland@pcrn.co.nz
    • Upper Hutt, Auckland, New Zealand, 5018
      • Not yet recruiting
      • PCRN Wellington, Ebdentown
      • Contact: Enrollment Coordinator; Phone Number: +64 4 9201800; Email: clinicaltrials@uhhc.co.nz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Phase 1

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1, Part 1: SAD Cohorts: Active Drug; Healthy volunteers will receive a single dose of PRA-216 in a dose escalation format.	Drug: PRA-216; biologic
Placebo Comparator: Phase 1, Part 1: SAD Cohorts: Placebo; Healthy volunteers will receive a single dose of placebo	Drug: Placebo; matching placebo for PRA-216
Experimental: Phase 1, Part 2: MAD Cohort: Active Drug; Healthy volunteers will receive repeated doses of PRA-216 in a dose escalation format.	Drug: PRA-216; biologic
Placebo Comparator: Phase 1, Part 2 MAD Cohort: Placebo Comparator; Healthy volunteers will receive repeated doses of placebo comparator.	Drug: Placebo; matching placebo for PRA-216
Experimental: Phase 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.	Drug: PRA-216; biologic
Placebo Comparator: Phase 2a: Participants with mild to moderate asthma-placebo; Participants with mild to moderate asthma will be randomized to receive repeat doses of placebo.	Drug: Placebo; matching placebo for PRA-216

What is the study measuring?

Primary 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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prana Therapies Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: asthma; pharmacokinetics; immunogenicity; healthy volunteers; pharmacodynamics
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: PRA-216-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No