Status:
COMPLETED
MT1013 Clinical TRIAL In Healthy Subject
Lead Sponsor:
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Collaborating Sponsors:
WCCT Global
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled, single ascending dose administration phase one clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodyn...
Detailed Description
This will be a single center, Phase 1, randomized, double-blind single-dose, sequential SAD study. This SAD study will consist of up to 5 cohorts (1 cohort per dose level). Each cohort will include 8...
Eligibility Criteria
Inclusion
- Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age, with BMI \>18.0 and \<30.0 kg/m2 and body weight ≥45.0 kg for males and females.
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
- the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, GI, renal, hepatic, and metabolic disease.
- Females of childbearing potential who are sexually active with a non-sterile male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
- Capable of consent.
Exclusion
- Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, hepatitis C, or Treponema pallidum antibody found during medical screening.
- Positive urine drug screen or urine cotinine test or alcohol breath test at screening.
- Positive fecal occult blood test at screening.
- History of clinically significant drug allergies.
- Positive pregnancy test at screening.
- Clinically significant ECG abnormalities (QTcF ≥450 ms) or a family history of long QT syndrome.
- Clinically significant vital sign abnormalities at screening.
- History of significant alcohol abuse within 1 year prior to screening.
- History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days or 5 half-lives (whichever is longer) prior to the first dosing.
- Use of prohibited medications for the timeframes specified.
- Donation of plasma within 7 days prior to dosing.
- Breast-feeding subject.
- The combination of diseases that may affect the assessment of drug absorption, distribution, metabolism, excretion and safety data, or that can reduce compliance.
- Subjects with previous clinically significant history of epileptic seizures.
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04783090
Start Date
June 28 2021
End Date
March 17 2022
Last Update
July 29 2022
Active Locations (1)
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1
WCCT Global, Inc.
Cypress, California, United States, 90630