Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PRA-216, Placebo.
- Who it may be relevant to
- Registry conditions: Mild to Moderate Asthma. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
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.
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.
Interventions
- Drug PRA-216
biologic - Drug Placebo
matching placebo for PRA-216
Primary outcome measures
- Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) with a single dose of PRA-216 in healthy volunteers (SAD arm) [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) [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 [Time frame: Up to Study Day 57]
Secondary outcome measures (9)
- Phase 1: Immunogenicity of PRA-216: ADA in healthy volunteers [Time frame: Up to Study Day 169]
- Phase 1: Pharmacokinetics of PRA-216: Tmax in healthy volunteers [Time frame: Up to Study Day 169]
- Phase 1: Pharmacokinetics of PRA-216: AUC in healthy volunteers [Time frame: Up to Study Day 169]
- Phase 1: Pharmacokinetics of PRA-216: Cmax in healthy volunteers [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 [Time frame: Up to Study Day 197]
- Phase 2a: Immunogenicity of PRA-216: ADA in patients with asthma [Time frame: Up to Study Day 197]
- Phase 2a: Pharmacokinetics of PRA-216: Tmax in patients with asthma [Time frame: Up to Study Day 197]
- Phase 2a: Pharmacokinetics of PRA-216: AUC in patients with asthma [Time frame: Up to Study Day 197]
- Phase 2a: Pharmacokinetics of PRA-216: Cmax in patients with asthma [Time frame: Up to Study Day 197]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Australia · 5 centers
- Emertitus Research Sydney — Botany
- Emeritus Research Camberwell — Camberwell
- Monash Health — Clayton
- Linear — Joondalup
- Linear — Nedlands
New Zealand · 3 centers
- PCRN Waikato, Nawton — Hamilton
- Pacific Clinical Research Network-Auckland — Takapuna
- PCRN Wellington, Ebdentown — Upper Hutt
Identifiers
NCT: NCT07245368 · PRA-216-101