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

NCT04277910 | Completed Phase 1 FDA Drug

• 1 other identifier: MT2004-I-A01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Cmax of MT2004

  Maximum observed concentration (Cmax) of MT2004

  48 hours

• AUClast of MT2004

  Area under the concentration-time curve (AUC) from Hour 0 to the last measurable concentration (AUC0-last) of MT2004

  48 hours

• Tmax of MT2004

  Time to maximum concentration (Tmax)

  48 hours

• T half of MT2004

  T half of MT2004

  48 hours

• Plasma FGF19 Level

  Plasma FGF19 Level

  24 hours

• Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Level

  Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Level

  24 hours

Study Arms (2)

MT2004

ACTIVE COMPARATOR

MT2004 oral capsules treated group

Drug: MT2004

Placebo

PLACEBO COMPARATOR

Placebo oral capsules treated group

Drug: Placebo

Interventions

MT2004 DRUG

MT2004 oral capsules

MT2004

Placebo DRUG

Placebo oral capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are capable of giving informed consent and complying with study procedures;
• Are between the ages of 18 and 55 years, inclusive;
• Female subjects have a negative urine pregnancy test result at screening and Day -1, and meet one of the following criteria:
• Using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) \[e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)\]
• Surgically sterile for at least 3 months prior to screening by one of the following means:
• Bilateral tubal ligation
• Bilateral salpingectomy (with or without oophorectomy)
• Surgical hysterectomy
• Bilateral oophorectomy (with or without hysterectomy)
• Postmenopausal, defined as the following:
• Last menstrual period greater than 12 months prior to screening
• Postmenopausal status confirmed by serum follicle stimulating hormone (FSH) and estradiol levels at screening;
• Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12- lead ECG, and vital signs;
• Normal renal function as determined by Investigator following review of clinical laboratory test results;
• Non-smoker and no more than 2 tobacco-containing products including nicotine replacement products in last 6 months;

You may not qualify if:

• Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
• Known or suspected malignancy;
• History of pancreatitis or gall stones;
• History of unexplained syncope, symptomatic hypotension or hypoglycemia;
• Family history of long QTc syndrome;
• History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
• History of organ transplantation with the exception of cornea transplantation;
• Poor venous access;
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
• Donated or lost \>500ml of blood in the previous 3 months;
• Taken an investigational drug or participated in a clinical trial within 3 months (or 5 half- lives), whichever is longer;
• Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug;
• Hospital admission or major surgery within 6 months prior to screening;
• A history of prescription drug abuse, or illicit drug use within 9 months prior to screening;
• A history of alcohol abuse according to medical history within 9 months prior to screening;

Sponsors & Collaborators

• Xi'an Biocare Pharma Ltd.: lead

Study Sites (1)

Pharmaron CPC, Inc.

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Mohamed Al-Ibrahim, MD

  Pharmaron CPC, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, sequential parallel group

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: January 9, 2020
• Primary Completion: April 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)