* Safety, tolerability, PK and PD of MHS552 in adults with T1DM
Research type
Research Study
Full title
A randomized, investigator and participant blinded, placebo controlled, multiple ascending dose, two part design study to assess the safety, tolerability, pharmacokinetic and pharmacodynamic effects of MHS552 in adults with type 1 diabetes mellitus (T1DM)
IRAS ID
306409
Contact name
Colin Dayan
Contact email
Sponsor organisation
Novartis
Eudract number
2021-003519-24
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
The purpose of this study is to see if the study medication MHS552 is tolerable in comparison to placebo in patients with Type 1 diabetes mellitus (T1DM), as well as if there are any side effects of MHS552, how serious they might be, and how many times they happen compared with placebo. It will also assess how patients' bodies respond to MHS552 by assessing how the body absorbs, distributes, and gets rid of MHS552 (this is called pharmacokinetics).
MHS552 has already been examined in one clinical study in healthy volunteers. The safety and effectiveness of MHS552 has not been established in people with T1DM.
This study will be conducted in two parts, Part A and Part B. Part A will look at the effects of increasing doses of MHS552 or placebo in small group of patients with T1D for 4 weeks treatment. Part B will assess the safety and tolerability of one dose level of MHS552 for a longer treatment period (12 weeks).
In this study, patients will be randomly assigned to receive MHS552 or placebo. There are multiple doses of MHS552 being tested, and patients will have a 3/4 chance of receiving MHS552 in Part A and and 1/4 chance of receiving placebo. In Part B this will be 2/3 and 1/3 respectively. The study treatment will be administered by injection under the skin.
In addition to MHS552 or placebo, patients will continue to receive their normal insulin treatment for the management of their diabetes.
Approximately 28 people with Type 1 diabetes mellitus aged 18 to 45 years inclusive are being invited to join this study in the United Kingdom. The pharmaceutical company named Novartis sponsors this study.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
22/WM/0187
Date of REC Opinion
17 Dec 2021
REC opinion
Further Information Favourable Opinion