A study to evaluate safety, PK and PD of ACT-01 in healthy subjects
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, follow-on single and multiple ascending dose extension study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory biomarkers of ACT-01 in healthy subjects
IRAS ID
290373
Contact name
Annelize Koch
Contact email
Sponsor organisation
Accure Therapeutics
Eudract number
2020-005093-96
Duration of Study in the UK
0 years, 4 months, 18 days
Research summary
The purpose of this study is to investigate ACT-01. The objectives of this study are:
- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of ACT-01 when it is administered as single and multiple doses at different dose strengths over a period of up to 5 days.
- To investigate the concentration of ACT-01 in the blood, how this changes over a period of time whether there are differences in the concentration profile between different dose strengths & between single or multiple doses.
This study will be split into 2 parts: Part A & Part B.
The purpose of Part A is to investigate ACT-01 when given as a single dose on one occasion at different dose strengths. Part A will consist of up to 3 groups of 8 participants; each group investigating a different dose strength.
The purpose of Part B is to investigate ACT-01 when given once a day for 5 days at the same dose strengths as investigated in Part A i.e. Group 1 in Part B investigates the same dose as Group 1 in Part A and so on. Part B will consist of 3 groups of 8 participants.
Participants in both parts will either be given ACT-01 or a placebo (which contains no active drug). Both ACT-01 and the placebo will be administered in the form of an intravenous infusion (a needle in the arm attached to an infusion bag which administers the drug slowly into the body over a 2-hour period). Dose strengths for both parts will be 4 mg/kg, 5 mg/kg & 6 mg/kg.
Blood samples will be taken at set time points to measure the concentration profile of ACT-01 in the blood, how this changes over time and how this compares between each study group.
REC name
Wales REC 2
REC reference
20/WA/0287
Date of REC Opinion
10 Dec 2020
REC opinion
Further Information Favourable Opinion