drugset / Trial / NCT05844787

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Profile of MT101-5 in Healthy Volunteers

NCT05844787 ↗

RandomizedSequentialDouble-blindTreatment

Summary

The primary study objective is to establish the safety and tolerability of MT101-5 after a single and multiple dose administrations in healthy volunteers. The safety and overall tolerability of MT101-5 will be evaluated based on: * Incidence of Dose Limiting Toxicities (DLTs) * Incidence of Treatment-Emergent Adverse Events (TEAEs). * Incidence of withdrawals due to Adverse Events (AEs). * Change/shifts in laboratory values. Change in vital signs. * Change in Electrocardiogram (ECG) parameters. * Changes in physical examination findings

Timeline

Start
2022-07-11
Primary completion
2023-02-23
Completion
2023-02-23

Drugs

EvaluationDrugModalityDoseRoute
Subject MT101-5 Unknown 100 mg Oral
Subject MT101-5 Unknown 150 mg Oral
Subject MT101-5 Unknown 300 mg Oral
Subject MT101-5 Unknown 450 mg Oral
Subject MT101-5 Unknown 600 mg Oral

Indications