A study to evaluate safety and PK of ENX-102 in healthy volunteers
Research type
Research Study
Full title
A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of ENX-102 in Healthy Volunteers
IRAS ID
293950
Contact name
Annelize Koch
Contact email
Sponsor organisation
Engrail Therapeutics, Inc.
Eudract number
2021-000406-24
Duration of Study in the UK
0 years, 4 months, 19 days
Research summary
Summary of Research\nThe purpose of this study is to investigate ENX-102. \n\nThe objectives of this study are:\n\n- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of ENX-102 when it is administered as a single dose at different dose strengths on one occasion.\n\n- To investigate the amount of ENX-102 in the blood after a single oral dose, how the amount of ENX-102 in the blood changes over time, and whether there are differences in the amount of ENX-102 in the blood when ENX-102 is given at different dose strengths. \n\nThis study will consist of 6 planned groups of 8 participants (males and females of childbearing and non-childbearing potential aged between 18 & 55): each group investigating a different dose strength of ENX-102 ranging from 0.5 mg to 10 mg.\n\nIn this study, participants will either be given ENX-102 or a placebo (which contains no active drug). Both ENX-102 and the placebo will be administered in the form of an oral capsule or multiple capsules (dependent on dose strength). 6 participants in each group will receive active ENX-102 and the remaining 2 participants will receive the placebo.\n\nBlood samples will be taken at set time points throughout the study in order to measure the amount of ENX-102 in the blood. \n\nWe will compare the results from each of the groups to determine if there are any significant differences in the safety of ENX-102, the amount of ENX-102 in the blood, how this changes over time and whether there are any differences between the different dose strengths.\n\nThe purpose of the data generated in this study is to provide further information and guidance to support the study sponsor in development of the study drug.\n\nSummary of Results\nThe purpose of the study was to investigate the study drug ENX-102.\n\nThe main objectives of the study were as follows:\n\n- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of ENX-102 when it was administered as a single dose at different dose strengths on one occasion.\n\n- To investigate the amount of ENX-102 in the blood after a single oral dose, how the amount of ENX-102 in the blood changed over time, and whether there were differences in the amount of ENX-102 in the blood when ENX-102 was given at different dose strengths. \n\nThe study consisted of 6 planned groups of 8 participants: with participants in each group receiving a different dose strength.\n\nIn this study, participants were given either ENX-102 or a placebo (which contains no active drug). Both ENX-102 and the placebo were administered in the form of an oral capsule or multiple capsules (dependent on dose strength). 6 participants in each group received active ENX-102 and the remaining 2 participants received the placebo. Blood samples were taken at set time points throughout the study in order to measure the amount of ENX-102 in the blood. \n\nThe results of each group were compared to determine if there were any significant differences in the safety of ENX-102, the amount of ENX-102 in the blood, how this changed over time and whether there were any differences between the different dose strengths.\n\nThe purpose of the data generated in this study was to provide important information so that the study sponsor can further develop the study drug.\n\nWith respect to the safety objectives of the study, it was determined that ENX-102 was considered to be safe and well tolerated after single doses at all dose strengths evaluated in the study (0.5 mg – 10 mg). There was an identified trend of higher incidences of reported adverse events (side effects) as the dose strength increased; however the reported effects were aligned with the types of effects reported for the study drug in previous clinical trials using an alternative form of ENX-102. All adverse events which were reported were considered to be mild to moderate in severity and resolved before the study completed.\n\nWith respect to the other objectives of the study, the following outcomes were reported:\n\n- ENX-102 is rapidly absorbed with levels of the study drug detectable in the blood within 15-30 minutes following dosing at all dose strengths evaluated.\n\n- The maximum levels in the blood were observed within 1-4 hours following administration and the maximum concentration in the blood increased with the dose strength administered.\n\n- The time taken for the levels of the drug in the blood to halve (known as the half-life) was long, with this time ranging from 41-72 hours across all dose strengths evaluated.\n\n- Assessments of how the drug is distributed in the body showed that the drug is widely distributed.\n\nIn summary, the data gathered during the study was considered sufficient to meet the objectives of the study and warrant further clinical trials and investigations of the study drug.\n
REC name
Wales REC 2
REC reference
21/WA/0065
Date of REC Opinion
12 Mar 2021
REC opinion
Favourable Opinion