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

NCT07245368 | Recruiting Phase 1 DMC

• 1 other identifier: PRA-216-101
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 7

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 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.

Conditions

Mild to Moderate Asthma

Keywords

healthy volunteers; pharmacodynamics; immunogenicity; asthma; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Phase 1: Immunogenicity of PRA-216: ADA in healthy volunteers

  Up to Study Day 169

• Phase 1: Pharmacokinetics of PRA-216: Tmax in healthy volunteers

  Up to Study Day 169

• Phase 1: Pharmacokinetics of PRA-216: AUC in healthy volunteers

  Up to Study Day 169

• Phase 1: Pharmacokinetics of PRA-216: Cmax in healthy volunteers

  Up to Study Day 169

• Phase 2a: Incidence, nature, and severity of serious adverse events (SAEs) of PRA-216 in patients with asthma

  Up to Study Day 197

Study Arms (6)

Phase 1, Part 1: SAD Cohorts: Active Drug

EXPERIMENTAL

Healthy volunteers will receive a single dose of PRA-216 in a dose escalation format.

Drug: PRA-216

Phase 1, Part 1: SAD Cohorts: Placebo

PLACEBO COMPARATOR

Healthy volunteers will receive a single dose of placebo

Drug: Placebo

Phase 1, Part 2: MAD Cohort: Active Drug

EXPERIMENTAL

Healthy volunteers will receive repeated doses of PRA-216 in a dose escalation format.

Drug: PRA-216

Phase 1, Part 2 MAD Cohort: Placebo Comparator

PLACEBO COMPARATOR

Healthy volunteers will receive repeated doses of placebo comparator.

Drug: Placebo

Phase 2a: Participants with mild to moderate asthma-active drug

EXPERIMENTAL

Participants with mild to moderate asthma will be randomized to receive repeat doses of PRA-216.

Drug: PRA-216

Phase 2a: Participants with mild to moderate asthma-placebo

PLACEBO COMPARATOR

Participants with mild to moderate asthma will be randomized to receive repeat doses of placebo.

Drug: Placebo

Interventions

Placebo DRUG

matching placebo for PRA-216

Phase 1, Part 1: SAD Cohorts: Placebo; Phase 1, Part 2 MAD Cohort: Placebo Comparator; Phase 2a: Participants with mild to moderate asthma-placebo

PRA-216 DRUG

biologic

Phase 1, Part 1: SAD Cohorts: Active Drug; Phase 1, Part 2: MAD Cohort: Active Drug; Phase 2a: Participants with mild to moderate asthma-active drug

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Prana Therapies Inc: lead

Study Sites (7)

Emertitus Research Sydney

Botany, New South Wales, 2019, Australia

NOT YET RECRUITING

Emeritus Research Camberwell

Camberwell, Victoria, 3124, Australia

NOT YET RECRUITING

Linear

Joondalup, Western Australia, 6027, Australia

NOT YET RECRUITING

Linear

Nedlands, Western Australia, 6009, Australia

RECRUITING

PCRN Waikato, Nawton

Hamilton, Auckland, 3200, New Zealand

NOT YET RECRUITING

Pacific Clinical Research Network-Auckland

Takapuna, Auckland, 0622, New Zealand

NOT YET RECRUITING

PCRN Wellington, Ebdentown

Upper Hutt, Auckland, 5018, New Zealand

NOT YET RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Linear site contact

CONTACT

+61 (0)8 6382 5110; enquiries@linear.org.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); NZ (3)