A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects

Study Overview
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Brief Summary
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This Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects

Detailed Description
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PRV-3279-1b is a Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects. Eligible subjects include healthy male or female adults, 18 to 50 years of age. Each subject will receive the assigned treatment over 29 days followed by a 56-day follow-up period.

Official Title
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PREVAIL 1: A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects

Conditions
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Safety

Intervention / Treatment
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* Biological: PRV-3279 or placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations. Body mass index (BMI) 18 to 32 kg/m2, inclusive. Male or female 18 to 50 years of age, inclusive. Nonpregnant women of childbearing potential (WOCBP) and sexually active men must agree to use effective birth control with male contraception during study participation through at least 3 months after the final dose. Women of non-childbearing potential may participate. Exclusion Criteria: Women who are pregnant or breastfeeding. Evidence of active or chronic infections. Previous exposure to PRV-3279. Any reason that, in the opinion of the Investigator, would contraindicate the subject's participation in the study or confound the results of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Double-blind, placebo-controlled, multiple ascending dose study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A (PRV-3279 or placebo)<br>Sterile solution for intravenous administration, 3 doses, every 2 weeks | Biological: PRV-3279 or placebo<br>* bi-specific antibody-based molecule<br>|
| Experimental: Cohort B (PRV-3279 or placebo)<br>Sterile solution for intravenous administration, 3 doses, every 2 weeks | Biological: PRV-3279 or placebo<br>* bi-specific antibody-based molecule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Assessment of safety and tolerability | 85 days |