Safety, tolerability, PK and PD of subcutaneous HTL0030310 (QSC200729)
Research type
Research Study
Full title
A Three-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of HTL0030310 in Healthy Subjects
IRAS ID
252146
Contact name
Flavia Pizzagalli
Contact email
Sponsor organisation
Heptares Therapeutics
Eudract number
2018-003169-33
Duration of Study in the UK
0 years, 8 months, 8 days
Research summary
Heptares Therapeutics (the sponsor) is developing a new test medicine (HTL0030310) that mimics some of the actions in the body of a naturally occurring hormone called somatostatin. The test medicine is being developed to treat serious diseases caused by tumours developing from endocrine cells. The normal function of endocrine cells is to produce hormones however; sometimes something happens to these cells that causes them to start to grow and function abnormally and they start to develop into tumours, producing too much hormone. The test medicine is designed to stop certain endocrine tumour cells from overproducing hormones.
This study will look at the safety and tolerability of the test medicine and will also look at how well the new test medicine stops the release of hormones from the cells producing them.
The study will consist of 3 parts. In Part 1, single doses of the test medicine, HTL0030310, will be given in 64 healthy male and female volunteers. Once dosed, volunteers will remain on site for 2 days for blood samples to be taken and safety assessments performed. Part 2 of the study is a positive control. The effect on certain hormone levels will be assessed when a marketed medicine, Signifor® (for Cushing's disease), is given in up to 16 healthy male and female volunteers. The hormone response of the body to 3 different challenge agents will be assessed over 4 periods. Each period, volunteers will remain on site for 3 days. In Part 3, the effect on the same hormones will be assessed when single doses of the test medicine are given (with the same challenge agents) in up to 80 healthy male and female volunteers over 3 periods. Each period, volunteers will remain on site for 3 days.
REC name
Wales REC 2
REC reference
18/WA/0394
Date of REC Opinion
5 Dec 2018
REC opinion
Further Information Favourable Opinion