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

Parkinson's Disease Clinical Trial

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study Including a Food Interaction Study, Followed by a Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics Profile of MT101-5 in Healthy Volunteers

Status Completed

Clinical Trial 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

Clinical Trial Description

SAD Phase including Food Interaction:

Subjects will be assigned to one of up to five MT101-5 treatment cohorts and will be randomly assigned 6:2 within their cohort to receive MT101-5 or placebo. On Day 1, following an overnight fast of at least 10 hours, the randomly assigned dose of MT101-5 or placebo will be administered as oral tablet in a fasting state with 240 mL (i.e., 8 fluid ounces) of water. Additional water is permitted ad lib except for the period 1 hour before to 1 hour after administration of the drug product. No food is allowed for at least 4 hours after the dose. Subjects should receive standardized meals scheduled at the same time throughout the study.

For the Food Interaction phase, on Day 1 following an overnight fast of at least 10 hours, the study subjects should start their standardized high-fat breakfast meal 30 minutes before administration of the drug product. Trial subjects should eat this meal in 30 minutes or less. Subjects will be administered MT101-5 or placebo as an oral tablet 30 minutes after start of intake of a standardized high-fat breakfast with 240 mL (8 fluid ounces) of water. Additional water is allowed ad lib except for 1 hour before and 1 hour after drug administration. No food is allowed for at least 4 hours after the dose.

MAD Phase:

Subjects will be randomly assigned 6:2 to receive MT101-5 or placebo once daily for 7 days. On Day 1, following an overnight fast of at least 10 hours, the randomly assigned dose of MT101-5 or placebo will be administered as oral tablet in a fasting state with 240 mL (i.e., 8 fluid ounces) of water. Additional water is permitted ad lib except for the period 1 hour before to 1 hour after administration of the drug product. No food is allowed for at least 4 hours after the dose. Subjects should receive standardized meals scheduled at the same time throughout the study. The same will be followed for days 2-7. ;

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

• NCT number: NCT05844787
• Study type: Interventional
• Source: Mthera Pharma Co., Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: July 11, 2022
• Completion date: February 23, 2023