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

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.

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.