NCT05257798

A Study to Learn About The Study Medicine (Called PF-06823859) in Healthy Chinese Participants

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO CONTROLLED, STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY FOLLOWING A SINGLE DOSE OF PF-06823859 IN HEALTHY CHINESE PARTICIPANTS

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

Summary

The purpose of this clinical trial is to learn if the study medicine (called PF-06823859) is safe and how it is processed in healthy Chinese participants. This study is seeking participants who: * Are between 18 to 45 years of age, inclusive, at the time of signing the Informed Consent Document (ICD). * Are Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12 lead ECG (electrocardiogram). * Have a BMI (body mass index) of 19 to 27 kg/m2 (inclusive); and a total body weight \>50 kg (110 lb). All participants in this study will receive PF-06823859 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-06823859 will be given as an infusion directly into a vein. We will compare the experiences of people receiving PF-06823859 to those of people who do not. This will help us determine if PF-06823859 is safe and how it behaves inside the human body. Participants will take part in this study for up to 157 days. During this time, they will receive PF-06823859 or placebo and be observed for any effects.

Detailed description

This is a Phase 1, randomized, double blind, sponsor open, placebo controlled study to evaluate the PK, safety, and tolerability following a single dose of PF 06823859 (900 mg) in healthy Chinese participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	IFN-β inhibitor treatment	PF-06823859 (IFN-β inhibitor) 100 mg/mL solution for injection
OTHER	Placebo	Placebo for PF-06823859, 0 mg/mL solution for injection

Timeline

• Start date: 2022-02-28
• Primary completion: 2023-03-21
• Completion: 2023-03-21
• First posted: 2022-02-25
• Last updated: 2024-08-14
• Results posted: 2024-08-14

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study