Phase 1 SAD/MAD study of SBT-020 in Healthy Subjects (QCL117533)
Research type
Research Study
Full title
A Two-Part, Phase I Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending (Part 1) and Multiple Ascending Doses (Part 2) of SBT-020 Administered Subcutaneously using a Randomized, Double Blind, Placebo-Controlled, Parallel Group Design (SBT20-101)
IRAS ID
188106
Contact name
Gregory Gordon
Contact email
Sponsor organisation
Stealth Biotherapeutics
Eudract number
2015-003319-39
Duration of Study in the UK
0 years, 4 months, 14 days
Research summary
The Sponsor is developing the study drug, SBT-020, for the potential treatment of diseases that are thought to result from oxidative stress (a reaction that can cause damage to the cells in the body), including heart and kidney diseases, age related degenerative diseases of the eye, diabetes, neurodegenerative diseases, and genetic mitochondrial diseases. \n\nThe study will investigate how the study drug SBT-020 is taken up by the body in comparison with a placebo (dummy drug), following single and multiple doses of the study drug. The safety and tolerability of the study drug will also be assessed. \n\nThe study will consist of 2 parts involving up to 80 healthy male and female subjects in total. In Part 1, up to 32 subjects in 4 separate cohorts will receive a single dose of up to 40 mg/mL study drug or placebo given subcutaneously (as an injection just under the skin). In Part 2, up to 48 subjects in 4 separate cohorts will receive a dose of up to 40 mg/mL study drug or placebo, given subcutaneously once daily for 7 days.
REC name
Wales REC 2
REC reference
15/WA/0297
Date of REC Opinion
7 Oct 2015
REC opinion
Further Information Favourable Opinion