A First-in-Human Single and Multiple Ascending Dose Study of MT-251
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorMirador Therapeutics, Inc.
About this trial
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-251 in Healthy Participants
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female participants 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 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.
Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to the first dose of drug.
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
Parallel
Treatments tested in this trial
MT-251
DrugMT-251
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Part 1- Single Ascending DoseExperimental treatment 1 intervention
Group B: Part 2- Multiple Ascending DoseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov