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

Phase 2RecruitingNCT07245368

Prana Therapies Inc96 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (8)

Emertitus Research Sydney

Botany, New South Wales, Australia

RECRUITING

Emeritus Research Camberwell

Camberwell, Victoria, Australia

RECRUITING

Monash Health

Clayton, Victoria, Australia

NOT_YET_RECRUITING

Linear

Joondalup, Western Australia, Australia

RECRUITING

Linear

Nedlands, Western Australia, Australia

RECRUITING

PCRN Waikato, Nawton

Hamilton, Auckland, New Zealand

RECRUITING

Pacific Clinical Research Network-Auckland

Takapuna, Auckland, New Zealand

RECRUITING

PCRN Wellington, Ebdentown

Upper Hutt, Auckland, New Zealand

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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.

Time frame: Up to Study Day 57

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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)