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

NCT05257798 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-08-14

Study results available
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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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2023-03-21
Completion
2023-03-21
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257798 on ClinicalTrials.gov