NCT04269538

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Telavant, Inc. · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, double-blind, third-party open (ie, participant-blind, investigator-blind and sponsor-open), placebo-controlled, dose escalating clinical study to evaluate the safety, tolerability, immunogenicity, PK and PD of PF-06480605 in Japanese healthy adult participants.

Detailed description

Approximately 16 participants are planned to be enrolled into the study. The study consists of 2 cohorts, and approximately 6 participants will be randomized to PF-06480605 and approximately 2 participants will be randomized to placebo in each cohort. Each participant will receive PF-06480605 or placebo subcutaneously.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PF-06480605	PF-06480605 150 mg and 450 mg SC dosing
DRUG	Placebo	Placebo SC dosing

Timeline

• Start date: 2020-02-19
• Primary completion: 2020-11-11
• Completion: 2020-11-11
• First posted: 2020-02-17
• Last updated: 2023-10-19

Locations

1 site across 1 country: Japan