Safety, Tolerability and PK of UNI-494 in Healthy Volunteers (QSC207400)
Research type
Research Study
Full title
A Two-Part Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of UNI-494 with an Optional Third-Part to Assess the Relative Bioavailability Compared to Nicorandil in Healthy Male and Female Subjects
IRAS ID
1006558
Contact name
Sanjay Mourya
Contact email
Sponsor organisation
Unicycive Therapeutics Inc.
Eudract number
2022-003223-17
ISRCTN Number
ISRCTN16476560
Research summary
The Sponsor is developing a new test medicine, UNI-494, for the potential treatment of acute kidney injury (AKI). AKI is a sudden loss of kidney function over hours or days, where the kidneys stop working properly, causing loss of kidney function, from relatively minor to complete kidney failure.
This up to three-part, First-in-Human healthy volunteer study will try to identify the safety and tolerability of single and multiple doses of the test medicine. It may also compare the test medicine to the licenced product, nicorandil, which is available for doctors to prescribe (optional).
This study will take place at one non-NHS site, enrolling up to 64 male and female (not of childbearing potential) volunteers aged between 18 and 55 years of age.
In Part 1, 32 volunteers will be split into 4 groups and will receive a single dose of the test medicine or placebo, at different dose levels. One group may be required to return for an additional study visit to receive a single dose of the test medicine in the fed state, or at a higher dose level.
In Part 2, 20 volunteers will be split into 2 groups and will receive a single oral dose of the test medicine or placebo once or twice a day for 5 days in either the fed or fasted state.
Part 3 is optional, and if utilised, 12 volunteers in a single group will receive a single oral dose of the test medicine and a single oral dose of the reference product (nicorandil), one at each study visit.
In Part 1 and Part 3, volunteers will be discharged on Day 3 of each study and in Part 2, volunteers will be discharged on Day 8.
In all parts, volunteers will return to the clinic for a follow-up visit 7 to 10 days after final dose.
Volunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety.
Volunteers are expected to be involved in this study for 7 (Part 1 or 2) or 6 (Part 3) weeks from screening to the follow up visit.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0189
Date of REC Opinion
16 Dec 2022
REC opinion
Further Information Favourable Opinion