CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
IFN-β inhibitor treatment +1 moredrug
Likely dose
IFN-β inhibitor treatment 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05257798
NCT05257798Phase 1Completed

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

Pfizer·interventional·Posted Feb 25, 2022·Updated Aug 14, 2024

In Brief

A Phase 1 clinical trial evaluating IFN-β inhibitor treatment and Placebo for Healthy. Completed, enrolled 18 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedFeb 25, 2022
Enrollment StartFeb 28, 2022
Primary CompletionMar 21, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.4 years ago

Interventions

IFN-β inhibitor treatmentdrug

PF-06823859 (IFN-β inhibitor) 100 mg/mL solution for injection

Placeboother

Placebo for PF-06823859, 0 mg/mL solution for injection