Healthy Volunteers
Conditions
Keywords
MT-501, Phase 1
Brief summary
First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) with Single and Multiple Ascending Oral Doses of MT-501 in Healthy Adults.
Detailed description
This study is the first administration of MT-501 in healthy volunteers (HV). The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat oral doses of up to 8 days of MT-501 in HV. The safety, tolerability, PK, and PD data obtained from this study will inform further development of MT-501.
Interventions
DRUGMT-501
MT-501 Tablets
Sponsors
Mirador Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-Blind
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female (of non-childbearing potential only) between 19 and 55 years of age inclusive, at the time of signing informed consent. 2. Females must be of non-childbearing potential and must have undergone sterilization procedures, and have official documentation, at least 6 months prior to the first dose. 3. Male subjects must use highly effective forms of contraception during sexual intercourse with female partners of childbearing potential. A non-vasectomized, male subject must agree to use a condom with a chemical barrier method. 4. Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to the first dose of drug. 5. Good general health. 6. Able to provide written informed consent and understand and comply with the requirements of the study.
Exclusion criteria
1. History or presence of any clinically significant organ system disease. 2. Abnormal laboratory assessments, physical exam of ECG outside the normal range that is judged by the Investigator to be clinically significant. 3. History of alcohol or drug abuse within the past 24 months. 4. Current use or history of regular tobacco, or nicotine-containing products within 3 months prior to screening. 5. Administration or use of any investigational drug or device within 30 days preceding the first does of study drug administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure: Number of Subjects with non-SAEs and SAES | Up to 14 days post dose | Incidence of adverse events, clinically significant laboratory abnormalities, clinically significant electrocardiogram, vital signs, and physical examination abnormalities. |
Countries
United States
Outcome results
None listed