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

NCT05844787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-05-06

No results posted yet for this study

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

Conditions

Interventions

DRUG

MT101-5

Tablet

Sponsors & Collaborators

  • Amarex Clinical Research

    collaborator OTHER

  • Mthera Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2023-02-23
Completion
2023-02-23
FDA Drug
Yes

Countries

  • United States

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 NCT05844787 on ClinicalTrials.gov