Study to Evaluate Safety, Tolerability and PK of SP-8356 (QSC203324)
Research type
Research Study
Full title
A Phase I Single-Centre, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8356
IRAS ID
280168
Contact name
Dr Chung Ju
Contact email
Sponsor organisation
Shin Poong Pharm. Co., Ltd
Eudract number
2020-001216-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 2 days
Research summary
Summary of Research
The Sponsor, Shin Poong, is developing a new test medicine, SP-8356, for the potential treatment of cardio-cerebrovascular diseases (diseases of the blood vessels in the heart and the brain), such as atherosclerosis. These diseases occur when fatty substances clog the blood vessels supplying blood to the body. The vessels begin to harden and narrow, restricting blood and increasing the risk of blood clots.
This is a two part, single-centre, randomised study that will try to investigate the safety and tolerability of the test medicine, and what the test medicine does to the body (pharmacokinetics) of single and multiple ascending oral doses of SP-8356, with and without food, in healthy male volunteers.
In Part 1 approximately 40 healthy male volunteers will receive single escalating doses of the test medicine or placebo, fasted, with 8 volunteers per group. For each dosing occasion, each group will be split into two sub-groups, with initial sentinel dosing of two volunteers (one receiving the test medicine and the other receiving a dummy medicine (placebo)). At least 24 hours after the sentinel dosing, the remaining 6 volunteers will receive the test medicine or placebo. One group will return to receive another dose of the test medicine or placebo with food.
Part 2 will enroll approximately 27 volunteers in up to 3 separate groups. Volunteers will receive either multiple ascending doses of the test medicine or placebo, either once or twice daily, for 7 consecutive days in the fed or fasted state.
For both parts, there will be a minimum of 14 days between dosing of each group. Volunteers will remain in the clinical unit until 48 hours after their final dose. Volunteers will return for a follow up visit 5 to 7 days post dose(s) for safety assessments.
Summary of Results
Given that this is a Phase 1 trial, no lay summary has been provided for reasons of commercial sensitivity.
REC name
Wales REC 2
REC reference
20/WA/0336
Date of REC Opinion
10 Dec 2020
REC opinion
Favourable Opinion