Clinical Trial of AMG 592 Administered Subcutaneously
Research type
Research Study
Full title
A Phase 1, Open-label, Sequential-group, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 592 Administered Subcutaneously in Healthy Chinese, Japanese, and Caucasian Subjects
IRAS ID
297029
Contact name
Samuel Israel
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2021-001558-75
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
REC Reference Number, 21/NE/0060; IND Number, 131270
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
AMG 592 is a treatment for multiple inflammatory diseases including systemic lupus erythematosus (SLE), steroid-refractory chronic graft versus host disease (GvHD), and ulcerative colitis.
AMG 592 is a modified protein of interleukin 2 (IL-2) a protein which is responsible for helping the immune system by enhancing a type of cell called a T cell, helping the immune system take part in several roles when fighting infection.
AMG 592 helps increase the number of an immune cells which helps regulate the immune system (Treg) and therefore helping reduce the effects of some diseases where the bodies own cells attack themselves.AMG 592 exhibits greater selectivity for inducing Treg (T cells which regulate or suppress cells in the immune system). This greater selectivity of AMG592 has promise for greater efficacy and a larger margin between the drug being therapeutic and toxic in inflammatory diseases relative to low-dose recombinant IL 2-based treatments. It takes longer to be removed by the body and dosed less to be therapeutic in comparison to other treatments.
This study will evaluate whether pharmacokinetic (what the body does to the drug) and safety data in Chinese and Japanese participants are similar to the global population.
This will be an open-label, partially randomised, single-dose, parallel-arm study in 2 groups of healthy Chinese participants and 1 group of Japanese participants. In addition, a group of Caucasian participants will be evaluated at the high dose for comparison.
Thirty-two participants will be dosed in 4 groups consisting of 8 participants per group. Each group will receive a single SC (subcontaneous) dose as shown below. Groups 1 and 2 will be the Chinese cohort, group 3 will be the Japanese cohort and Group 4 will be the Caucasian cohort.
Group 1 = 1100 µg
Group 2 = 1800 µg
Group 3 = 1800 µg
Group 4 = 1800 µgREC name
North East - York Research Ethics Committee
REC reference
21/NE/0060
Date of REC Opinion
3 Jun 2021
REC opinion
Further Information Favourable Opinion