Safety, Tolerability and PK of SBT-272 in Healthy Subjects (QSC202648)
Research type
Research Study
Full title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SBT-272 in Healthy Subjects
IRAS ID
272036
Contact name
Sharan Sidhu
Contact email
Sponsor organisation
Stealth Biotherapeutics
Eudract number
2019-003895-37
Duration of Study in the UK
0 years, 4 months, 15 days
Research summary
The Sponsor, Stealth Biotherapeutics Inc. is developing the test medicine, SBT-272, for the potential treatment of neurodegenerative diseases such as Amyotrophic lateral sclerosis (ALS), also known as motor neurone disease (MND). Mitochondrial dysfunction can often be a causal factor of these diseases. This is where the mitochondria aren’t working correctly. Mitochondria are tiny organelles that are present in every cell in our bodies which generate about 90% of the energy we need to live. When the mitochondria are faulty this leads to less energy production and cell death, causing a range of problems. The test medicine aims to increase the amount of energy produced by the dysfunctional mitochondria to help prevent these problems. \n\nThe study will try to identify the safety and tolerability of multiple dose levels of the test medicine. It will also assess how the test medicine is taken up by the body (the pharmacokinetics). \n\nThis study is a dose-escalation study, consisting of 7 cohorts involving up to 56 healthy male and female volunteers. Each volunteers will receive a single dose of test medicine or placebo. This will be administered following an overnight fast of 8-hours.\n\nVolunteers will remain in the clinic until the 48-hour post-dose assessments are complete. Volunteers will return to the clinic for follow-up assessment approximately 2 days after discharge.\n
REC name
HSC REC A
REC reference
19/NI/0199
Date of REC Opinion
20 Dec 2019
REC opinion
Further Information Favourable Opinion