*Safety and PK of a single dose of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults
Research type
Research Study
Full title
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
IRAS ID
1006619
Contact name
Chaim Brickman
Contact email
Sponsor organisation
Upstream Bio, Inc.
Eudract number
2022-002698-26
Clinicaltrials.gov Identifier
Research summary
UPB-101 is a medication under development for the treatment of asthma, a potentially life-threatening condition estimated to affect over 300 million people worldwide. Despite the availability of several treatments, satisfactory asthma control remains an unmet need worldwide.
The immune system produces many proteins that lead to inflammation, which normally serves to protect us by helping to fight infection and promote healing. One of these proteins (Thymic stromal lymphopoietin or TSLP), is thought to play a key role in causing inflammation of the airways in asthma. UPB-101 blocks this protein from working and therefore prevents the inflammation it would usually cause.
This study is an ethno-bridging study that aims to characterise and compare the pharmacokinetics (PK, how the body absorbs, processes and excretes the drug) and safety of a single dose of UPB-101 injection under the skin in healthy Japanese and Non-Japanese Non-East Asian (NJNEA) adults. This study aims to complement the on-going multiple dosing study of UPB-101 in asthmatic patients, in order to further increase understanding of its clinical profile. The rationale for investigating a possible difference in the PK of UPB-101 attributable to the Japanese ethnicity is to determine the optimal dose and dosing frequency of UPB-101 in this specific population, which due to genetic differences may be different to that of other ethnicities.
This study will be conducted in one site in the UK. There will be a total of 32 participants (4 treatment groups each consisting of 8 participants). Treatment groups 1-3 will be made up of Japanese volunteers who will receive a single dose of 100, 200 or 300mg respectively. Treatment group 4 will contain 8 NJNEA adults who will receive a single dose of 300mg. There will be no placebo. This trial lasts approximately 15 weeks, including screening (3 weeks), dosing and in house period (15 days), and follow up visits (last visit Day 85).REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0668
Date of REC Opinion
24 Nov 2022
REC opinion
Further Information Favourable Opinion