CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Ponsegromab +1 moredrug
Likely dose
Not stated in 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/NCT05685264
NCT05685264Phase 1Completed

A PHASE 1, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY, AND TOLERABILITY OF PONSEGROMAB ADMINISTERED SUBCUTANEOUSLY IN HEALTHY ADULT CHINESE PARTICIPANTS

Pfizer·interventional·Posted Jan 17, 2023·Updated Oct 1, 2024

In Brief

A Phase 1 clinical trial evaluating Ponsegromab for Healthy. Completed, enrolled 18 participants across 2 sites.

Detailed Summary

The purpose of this clinical trial is to learn about the safety of the study medicine (ponsegromab) and how it undergoes change and elimination in healthy Chinese adults. This study is seeking male and female Chinese participants who are very healthy as confirmed after some medical tests. All participants in this study will receive Ponsegromab only once: * for half of the participants, ponsegromab will be given as a shot in the front of the thigh, abdomen, or outer area of the upper arm at the study clinic. * for another half of the participants, ponsegromab will be given as four shots in the front of the thigh, abdomen, or outer area of the upper arm at the study clinic. We will measure the amount of the study medicine in the blood of the participants after giving the shots. Later we will examine experiences of people receiving the study medicine. This will help us understand how the medicine is changed and eliminated from your body and to decide if the study medicine is safe. Participants will take part in this study for 22 weeks. During this time, they will stay at the study clinic for the first 8 days and will visit the study clinic about 8 times.

Study Details

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

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJan 17, 2023
Enrollment StartJan 18, 2023
Primary CompletionJul 7, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.5 years ago

Interventions

Ponsegromabdrug

Participants will receive one subcutaneous injection

Ponsegromabdrug

Participants will receive four subcutaneous injections