Phase I First-In-Human Study of GUB014295 (QSC300771)
Research type
Research Study
Full title
A First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of GUB014295 in Lean to Overweight or Obese but Otherwise Healthy Men
IRAS ID
1008236
Contact name
Mads Axelsen
Contact email
Sponsor organisation
Gubra A/S
ISRCTN Number
ISRCTN85112396
Research summary
The Sponsor is developing the test medicine, GUB014295, as a potential treatment for obesity. Around 15% of the world’s population are obese. Obesity increases the risk of certain diseases and medical conditions, for example type 2 diabetes, heart disease and fatty liver disease which can decrease life expectancy and quality of life.
In this study, we’ll give healthy volunteers single doses of test medicine, to assess the safety and tolerability by reviewing side effects, and measuring what the body does to the test medicine.
The test medicine hasn’t been given to humans before. We’ll start with a low dose and test higher doses as the study progresses.
This study will take place at one site in Nottingham.
We plan to enrol up to 48 healthy men aged 18-55 years, split evenly across up to 6 cohorts.
Volunteers in each cohort will receive a single dose of test medicine or placebo (dummy medicine), at different dose levels, by injection under the skin. Volunteers will stay in the clinic for up to 5 nights, attend 6 return visits, and take up to 10 weeks to finish the study.
We’ll collect blood and urine samples to:
* complete safety tests.
* measure the amount of test medicine and its breakdown products.
* assess the effect of the test medicine on blood levels of substances linked to processing of sugar in the diet.
* assess the presence of anti-drug antibodies, which can indicate allergic reactions, following the study.REC name
HSC REC A
REC reference
23/NI/0109
Date of REC Opinion
10 Nov 2023
REC opinion
Further Information Favourable Opinion