Mild to Moderate Asthma
Conditions
Keywords
healthy volunteers, pharmacodynamics, immunogenicity, asthma, pharmacokinetics
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.
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
DRUGPRA-216
biologic
DRUGPlacebo
matching placebo for PRA-216
Sponsors
Prana Therapies Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) with a single dose of PRA-216 in healthy volunteers (SAD arm) | Up to Study Day 169 | Incidence, nature, and severity of serious adverse events (SAEs) |
| Phase 1: Incidence, nature, and severity of serious adverse events (SAEs) of multiple doses of PRA-216 in healthy volunteers (MAD arm) | up to Study Day 169 | Incidence, nature, and severity of and serious adverse events (SAEs) |
| Phase 2a: To evaluate the effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in asthma participants | Up to Study Day 57 | Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker of airway inflammation in asthma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Immunogenicity of PRA-216: ADA in healthy volunteers | Up to Study Day 169 | Incidence and magnitude of anti-drug antibody following single or multiple doses of PRA-216 |
| Phase 1: Pharmacokinetics of PRA-216: Tmax in healthy volunteers | Up to Study Day 169 | Time to maximum concentration of drug in plasma following single or multiple doses of PRA-216 |
| Phase 1: Pharmacokinetics of PRA-216: AUC in healthy volunteers | Up to Study Day 169 | Area under the curve following single or multiple doses of PRA-216 |
| Phase 1: Pharmacokinetics of PRA-216: Cmax in healthy volunteers | Up to Study Day 169 | Maximum concentration of PRA-216 in plasma following single or multiple doses of PRA-216. |
| Phase 2a: Incidence, nature, and severity of serious adverse events (SAEs) of PRA-216 in patients with asthma | Up to Study Day 197 | Incidence, nature, and severity of serious adverse events (SAEs) |
| Phase 2a: Immunogenicity of PRA-216: ADA in patients with asthma | Up to Study Day 197 | Incidence and magnitude of anti-drug antibody following drug administration |
| Phase 2a: Pharmacokinetics of PRA-216: Tmax in patients with asthma | Up to Study Day 197 | Time to maximum concentration of drug in plasma following multiple doses of PRA-216 |
| Phase 2a: Pharmacokinetics of PRA-216: AUC in patients with asthma | Up to Study Day 197 | Area under the curve of PRA-216 following multiple doses of PRA-216 |
| Phase 2a: Pharmacokinetics of PRA-216: Cmax in patients with asthma | Up to Study Day 197 | Maximum concentration in plasma of PRA-216 following multiple doses |
Countries
Australia, New Zealand
Contacts
CONTACTLinear site contact
Outcome results
None listed