*Phase I trial (QSC206116)
Research type
Research Study
Full title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SBT-272 Administered via Subcutaneous Injection in Healthy Subjects
IRAS ID
1004226
Contact name
Anthony Abbruscato
Contact email
Sponsor organisation
Stealth BioTherapeutics Inc
Eudract number
2021-004584-27
ISRCTN Number
ISRCTN12414966
Research summary
The Sponsor, Stealth Biotherapeutics Inc. is developing the test medicine, SBT-272, for the potential treatment of neurodegenerative diseases. Neurodegenerative diseases currently have no cure and can seriously affect a person’s mental functioning and movement. The test medicine aims to increase the amount of energy produced by the dysfunctional mitochondria to help prevent these problems. \nThis two-part healthy volunteer study will try to identify the safety and tolerability of single and multiple ascending doses (SAD/MAD) of the test medicine, as well as the amount of test medicine in the blood and urine over time (pharmacokinetics). \n\nThis study will take place at one non-NHS site in the UK, enrolling up to 64 healthy male and female volunteers aged between 18–55.\n\nIn Part 1 (SAD), up to 40 volunteers will be split into 5 cohorts to receive a single subcutaneous injection dose of SBT-272 or placebo. Volunteers will be discharged 48 hours post final dose on Day 3 and will return for a follow up visit on Day 5.\nIn Part 2 (MAD), up to 24 volunteers will be split into 3 cohorts to receive daily doses of SBT-272 or placebo via subcutaneous injection. Volunteers will be discharged 48 hours post final dose on Day 9 and will return for a follow up visit on Day 11.\nVolunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety. \n \nVolunteers are expected to be involved in this study for approximately 5 weeks from screening to the follow up visit.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/FT/0019
Date of REC Opinion
25 Feb 2022
REC opinion
Further Information Favourable Opinion