A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects (PREVAIL1)

Provention Bio

Status and phase: Completed; Phase 1

Conditions: Safety

Treatments: Biological: PRV-3279 or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03955666

PRV-3279-1b

Details and patient eligibility

About

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

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
2. Body mass index (BMI) 18 to 32 kg/m2, inclusive.
3. Male or female 18 to 50 years of age, inclusive.
4. 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

1. Women who are pregnant or breastfeeding.
2. Evidence of active or chronic infections.
3. Previous exposure to PRV-3279.
4. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

Cohort A (PRV-3279 or placebo)

Experimental group

Description:

Sterile solution for intravenous administration, 3 doses, every 2 weeks

Treatment:

Biological: PRV-3279 or placebo

Cohort B (PRV-3279 or placebo)

Experimental group

Description:

Sterile solution for intravenous administration, 3 doses, every 2 weeks

Treatment:

Biological: PRV-3279 or placebo