SJX-653 – first doses in men; ver 1
Research type
Research Study
Full title
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of SJX-653 in Healthy Adult Male Subjects (18-003).
IRAS ID
246088
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
Sojournix, Inc.
Eudract number
2018-000376-16
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine is an experimental new medicine for treating some of the symptoms of menopause, including hot flushes and night sweats. Most women will experience menopausal symptoms. These can be severe enough to interfere with day-to-day life. We hope that the study medicine will work by correcting the imbalance that causes hot flushes and night sweats. We’re doing this study in healthy men to answer these questions:\n*Do single doses of the study medicine have any important side effects when taken by mouth?\n*How much of the study medicine gets into the bloodstream, and how long does the body take to get rid of it?\n*What are the effects of the study medicine on the body? In particular, how does the study medicine affect the levels of certain hormones related to hot flushes?\n\nWe’ll give up to 36 healthy men, aged 18–45 years, a single dose. It’s never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. We aim to find out its side effects and blood levels. We’ll also test whether the study medicine affects the signals that control hormones levels; we’re doing this study in men because detecting small changes in hormone levels is easier in men than in women.\n\nParticipants will take up to 6 weeks to finish the study. They’ll make up to 2 outpatient visits, and stay on the ward for 3 nights.\n\nA pharmaceutical company (Sojournix, Inc) is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
18/NI/0075
Date of REC Opinion
16 May 2018
REC opinion
Favourable Opinion