drugset / Trial / NCT05844787
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Profile of MT101-5 in Healthy Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |