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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
MT-501 Tablets
Mirador Clinical Department
San Diego, California, United States
Primary Outcome Measure: Number of Subjects with non-SAEs and SAES
Incidence of adverse events, clinically significant laboratory abnormalities, clinically significant electrocardiogram, vital signs, and physical examination abnormalities.
Time frame: Up to 14 days post dose
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