Phase 1 Study of PRX019 in Healthy Adult Volunteers

A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo Controlled, First In Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending and Multiple Doses of PRX019 in Healthy Adults

The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.

Inclusion Criteria:

• Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period
• Participant is willing and able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted
• Participant was exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration, or within 7 times the elimination half-life, if known (whichever is longer)

NOTE: Other protocol-defined inclusion/exclusion criteria apply