At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 64 enrolled
Drug / intervention
AX-158drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Pharmacokinetics of AX-158 Following Administration of Single and, Multiple Ascending Oral Doses and Food Effect Sub-study in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating AX-158 for Autoimmune Diseases. Completed, enrolled 64 participants across 1 site.
Detailed Summary
This is a Phase I Healthy volunteer study with the primary objective to evaluate the safety and pharmacokinetics profile of AX-158. The first part will evaluate single ascending dose administrations. A substudy will be performed as well to evaluate possible impact of food on drug exposure if administered under fasted or fed state. The second part will evaluate multiple ascending dose over 10 days of dosing in fed or fast state depending on the results of the substudy food effect on AX-158.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutoimmune Diseases
CountriesUnited Kingdom
CollaboratorsSimbec-Orion Group
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartNov 2021
First PostedFeb 2022
Primary CompletionNov 2022
Study CompletionDec 2022
TodayJul 2026
First PostedFeb 1, 2022
Enrollment StartNov 17, 2021
Primary CompletionNov 16, 2022
Study CompletionDec 3, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 4.4 years ago
Interventions
AX-158drug
Oral administrations of AX-158