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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
MT-201
DrugMT-201
Placebo
DrugPlacebo
Treatment groups
72 Participants
are divided into 4 treatment groupsGroup A: Single Ascending Dose of MT-201Experimental treatment 1 intervention
Group B: Multiple Ascending Dose of MT-201Experimental treatment 1 intervention
Group C: Single Ascending Dose Placebo ArmPlacebo comparator 1 intervention
Group D: Multiple Ascending Dose PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants 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 40 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov