A Phase I study of Y14 in adult subjects
Research type
Research Study
Full title
A randomised, placebo controlled first in human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Y14 in adult subjects
IRAS ID
222848
Contact name
Jim Bush
Contact email
Sponsor organisation
Imperial College London| Imperial College Healthcare NHS Trust
Eudract number
2017-000380-33
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
REC, 17/NW/0084
Duration of Study in the UK
1 years, 0 months, 3 days
Research summary
Y14 is a new molecule, being developed as a treatment for obesity. Y14 binds to the Y2 receptor causing increased satiety (feelings of fullness after eating) and reduced body weight. There are licenced drugs with similar mechanisms of action, it is hoped that Y14 will have a greater duration of action and a better side-effect profile.
The main purpose of this first in man study is to assess safety and tolerability when Y14 is given as a SC (Subcutaneous, under the skin) injection. Other objectives include an assessment of the pharmacokinetics of the drug (how quickly the drug gets into the blood stream and how quickly it is removed from the body). An assessment of effects on food consumption, body weight hormone levels and glucose levels.
This study will be conducted in two parts. Part A will be a single dose study, in 5 cohorts of overweight but otherwise healthy subjects. Cohort 1 will consist of 4 subjects (3 active drug, 1 placebo (dummy drug). Each subject in cohort 1 will receive 3 single doses of drug at different dose levels. Cohort 2 onwards will consist of 6 subjects (5 active, 1 placebo) and each subject will be dosed once only. The first two subjects in cohort 1 will be dosed 1 week before the rest of the cohort on the first dosing occasion. For the second and third doses all subjects will be dosed on the same day. Part B will be a multiple dose study in patients with diabetes or pre-diabetes. Three dose levels will be tested in 3 cohorts, each of 8 subjects (6 active, 2 placebo Subjects will receive 5 doses of Y14 or placebo each separated by 7 days. Additional cohorts may be enrolled; up to 8 in Part A and 3 in Part B.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
17/NW/0084
Date of REC Opinion
22 Mar 2017
REC opinion
Favourable Opinion