NCT05354349

Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023

A Phase 1, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PRA023 in Healthy Caucasian and Japanese Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, and pharmacokinetics of PRA023 in healthy Caucasian and Japanese adult volunteers

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PRA023 IV Low Dose	Drug
DRUG	PRA023 SC	Drug
DRUG	Placebo IV	Placebo
DRUG	Placebo SC	Placebo
DRUG	PRA023 IV High Dose	Drug

Timeline

• Start date: 2022-04-06
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2022-04-29
• Last updated: 2024-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study