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A Study of the Safety, Tolerability, Pharmacokinetics and Food Effect After Single and Multiple Ascending Oral Doses

NCT05218434 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-08-23

Study results available
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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.

Conditions

Interventions

DRUG

AX-158

Oral administrations of AX-158

Sponsors & Collaborators

  • Simbec-Orion Group

    collaborator INDUSTRY

  • Artax Biopharma Inc

    lead INDUSTRY

Principal Investigators

  • Dr Annelize Koch · Simbec-Orion Merthyr Tydfil CF48 4DR, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2022-11-16
Completion
2022-12-03

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05218434 on ClinicalTrials.gov