CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
450mg +2 moredrug
Likely dose
450mgfrom 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/NCT05107492
NCT05107492Phase 1Completed

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

Pfizer·interventional·Posted Nov 4, 2021·Updated Mar 21, 2024

In Brief

A Phase 1 clinical trial evaluating 450mg, 150mg, and 1 other intervention for Inflammatory Bowel Disease. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedNov 4, 2021
Enrollment StartNov 19, 2021
Primary CompletionApr 9, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.7 years ago

Interventions

450mgdrug

following a single subcutaneous dose of PF-06480605 450 mg

150mgdrug

following a single subcutaneous dose of PF-06480605 150 mg

Placebodrug

following a single subcutaneous dose of placebo