NCT05107492

Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY FOLLOWING SINGLE SUBCUTANEOUS DOSE OF PF-06480605 IN CHINESE HEALTHY PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, single-center, randomized, double-blind, third-party open (ie, participant blind, investigator blind and sponsor open), placebo controlled study to investigate PK, safety, tolerability, immunogenicity, and PD of PF 06480605 following a single subcutaneous dose of PF-06480605 450 mg and 150 mg (if needed) in Chinese healthy adult participants.

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	450mg	following a single subcutaneous dose of PF-06480605 450 mg
DRUG	150mg	following a single subcutaneous dose of PF-06480605 150 mg
DRUG	Placebo	following a single subcutaneous dose of placebo

Timeline

• Start date: 2021-11-19
• Primary completion: 2022-04-09
• Completion: 2022-04-09
• First posted: 2021-11-04
• Last updated: 2024-03-21
• Results posted: 2024-03-21

Locations

1 site across 1 country: China