A First-in-Human Single and Multiple Ascending Dose Study of MT-201
ConditionHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorMirador Therapeutics, Inc.
About this trial
First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in healthy participants.
Eligibility criteria
Qualifiers
Male participant or female participant of nonchildbearing potential between 19 and 55 years of age (inclusive) at the time of signing informed consent.
Female participants must be of nonchildbearing potential, defined as postmenopausal or surgically sterile, and have official documentation, at least 6 months prior to the first dose.
Male participants with female partners of childbearing potential who are involved in heterosexual intercourse or activities that could lead to pregnancy must use barrier method of contraception (male condom) and refrain from sperm donation.
Good general health.
Disqualifiers
History or presence of any clinically significant organ system disease.
Abnormal laboratory assessments, physical exam of ECG outside the normal range that is judged by the Investigator to be clinically significant.
History of alcohol or drug abuse within the past 24 months.
Current use or history of regular tobacco, or nicotine-containing products within 3 months prior to screening.
Trial design
Treatments tested in this trial
- MT-201
- Placebo
Treatment groups
72 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov