A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Profile of MT101-5 in Healthy Volunteers
Status:
Completed
Trial end date:
2023-02-23
Target enrollment:
Participant gender:
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