HealthyPhase 1NCT04277910
A SAD/MAD Study to Evaluate the Safety, Tolerability, PK and PD of MT2004
A Phase 1 study testing MT2004 in people with Healthy, run by Xi'an Biocare Pharma Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MT2004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 30 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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;
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and body weight not less than 50 kg;
- Willing and able to adhere to study restrictions and to be confined at the clinical research center.
- Male subjects with female partners of child bearing potential must agree to use condoms for the duration of the study and until 12 weeks after dosing with the study drug and must refrain from donating sperm for this same period.
Who cannot join
- 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;
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- 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;
- A positive screen for alcohol and/or drugs of abuse at screening or Day
- -1;
- An unwillingness or inability to comply with food and beverage restrictions during study participation;
- Use of over-the-counter (OTC) medication within 7 days, and herbal (including St John's Wort, herbal teas, garlic extracts) within 7 days prior to dosing (Note: Use of acetaminophen at < 2 g/day is permitted until 24 hours prior to dosing);
- Pregnant or breast feeding at screening or planning to become pregnant during the study;
- Inability to swallow multiple capsules simultaneously
- Any condition or finding that in the Investigators opinion would put the subject or study conduct at risk if the subject were to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, SAD/MAD Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MT2004
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.
Read the detailed description
A total of 48 subjects will be evaluated with 36 subjects randomized to receive active drug and 12 subjects randomized to receive placebo in a double-blind fashion (eight subjects per each dose cohort, six subjects randomized to active drug and two subjects randomized to placebo). A separate open panel of 8 subjects will receive a single dose of MT2004 under fed conditions following the last of the SAD dose escalation cohorts. The dose level will be selected by the sponsor based upon the safety and PK data generated in each dose escalation cohort of the SAD part of the trial. A total of 24 subjects will receive MT2004 (8 subjects in each dose cohort for a total of 3 cohorts, 6 subjects randomized to active drug and 2 subjects randomized to placebo per cohort). MT2004 dosing regimens (dose levels and duration of administration) will be determined based on the collective SAD PK and safety data from Part 1 and nonclinical data of MT2004 (pharmacology and toxicology). Tentative dosing regimen is once daily for a consecutive 14 days.
- Conditions
- Healthy
- Being tested
- MT2004, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT2004Drug
MT2004 oral capsules
PlaceboDrug
Placebo oral capsules
| Study group | Role | What they receive |
|---|---|---|
| MT2004 | Active comparator | MT2004 oral capsules treated group Receives: Drug: MT2004 |
| Placebo | Placebo comparator | Placebo oral capsules treated group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of MT2004
Maximum observed concentration (Cmax) of MT2004
Measured: 48 hours
AUClast of MT2004
Area under the concentration-time curve (AUC) from Hour 0 to the last measurable concentration (AUC0-last) of MT2004
Measured: 48 hours
Tmax of MT2004
Time to maximum concentration (Tmax)
Measured: 48 hours
T half of MT2004
T half of MT2004
Measured: 48 hours
Plasma FGF19 Level
Plasma FGF19 Level
Measured: 24 hours
Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Level
Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Level
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start9 Jan 2020
- Primary completion30 Apr 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, double-blind, placebo-controlled, sequential parallel group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xi'an Biocare Pharma Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Al-Ibrahim, MD, Principal investigator, Pharmaron CPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277910
- Sponsor's protocol ID
- MT2004-I-A01
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, SAD/MAD Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MT2004
- ClinicalTrials.gov ID
- NCT04277910
- Acronym / sponsor ID
- MT2004-I-A01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Xi'an Biocare Pharma Ltd.University, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 48 subjects will be evaluated with 36 subjects randomized to receive active drug and 12 subjects randomized to receive placebo in a double-blind fashion (eight subjects per each dose cohort, six subjects randomized to active drug and two subjects randomized to placebo). A separate open panel of 8 subjects will receive a single dose of MT2004 under fed conditions following the last of the SAD dose escalation cohorts. The dose level will be selected by the sponsor based upon the safety and PK data generated in each dose escalation cohort of the SAD part of the trial. A total of 24 subjects will receive MT2004 (8 subjects in each dose cohort for a total of 3 cohorts, 6 subjects randomized to active drug and 2 subjects randomized to placebo per cohort). MT2004 dosing regimens (dose levels and duration of administration) will be determined based on the collective SAD PK and safety data from Part 1 and nonclinical data of MT2004 (pharmacology and toxicology). Tentative dosing regimen is once daily for a consecutive 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, sequential parallel group
| Arm | Type | Receives |
|---|---|---|
| MT2004 | Active comparator | Drug: MT2004MT2004 oral capsules treated group |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral capsules treated group |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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:
- 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;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT2004MT2004 oral capsules | Drug | MT2004 |
| PlaceboPlacebo oral capsules | Drug | Placebo |
Primary outcome
Cmax of MT2004
Time frame: 48 hours
Maximum observed concentration (Cmax) of MT2004
AUClast of MT2004
Time frame: 48 hours
Area under the concentration-time curve (AUC) from Hour 0 to the last measurable concentration (AUC0-last) of MT2004
Tmax of MT2004
Time frame: 48 hours
Time to maximum concentration (Tmax)
T half of MT2004
Time frame: 48 hours
T half of MT2004
Plasma FGF19 Level
Time frame: 24 hours
Plasma FGF19 Level
Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Level
Time frame: 24 hours
Serum 7-alpha-hydroxy-4-cholesten-3-one (C4) Level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Al-Ibrahim, MD principal investigator
Pharmaron CPC, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT2004 in people with Healthy, run by Xi'an Biocare Pharma Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of MT2004 (time frame: 48 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.