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A SAD/MAD Study to Evaluate the Safety, Tolerability, PK and PD of MT2004

NCT04277910 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2022-04-05

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of MT2004 following oral single and multiple ascending dose administration.

Conditions

  • Healthy

Interventions

DRUG

MT2004

MT2004 oral capsules

DRUG

Placebo

Placebo oral capsules

Sponsors & Collaborators

  • Xi'an Biocare Pharma Ltd.

    lead OTHER

Principal Investigators

  • Mohamed Al-Ibrahim, MD · Pharmaron CPC, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2021-04-30
Completion
2021-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04277910 on ClinicalTrials.gov