CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
UPB-101drug
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/NCT05653479
NCT05653479Phase 1Completed
CompareCT.gov

A Randomized, Open-label, Parallel-group, Ethno-bridging Study Comparing the Pharmacokinetics and Safety of a Single Dose of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults

Upstream Bio Inc.·interventional·Posted Dec 16, 2022·Updated Sep 3, 2024

In Brief

A Phase 1 clinical trial evaluating UPB-101 for Healthy. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The goals of this clinical study are to characterize and compare the safety, tolerability, blood levels of UPB-101 when given to healthy Japanese and non-Japanese non-East Asian (NJNEA) adults. Eligible participants will be assigned to one of the 4 planned dosing treatment groups. Treatment groups 1, 2 and 3 will consist of Japanese adults who will be administered a single subcutaneous (SC) dose of UPB-101 (at 3 different strengths). Treatment group 4 will consist of NJNEA participants who will receive a single SC dose of UPB-101. All treatment groups will enroll and run in parallel.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedDec 16, 2022
Enrollment StartDec 5, 2022
Primary CompletionApr 7, 2023
Study CompletionMay 13, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.5 years ago

Interventions

UPB-101drug

UPB-101 Subcutaneous injection