Healthy Volunteers
Conditions
Keywords
MT-251, Phase 1
Brief summary
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
Detailed description
This is a first-in-human study of MT-251, a biologic therapeutic. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-251 in healthy participants. The data obtained from this study will inform further development of MT-251.
Interventions
DRUGMT-251
MT-251
Sponsors
Mirador Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 participants between 19 and 55 years of age (inclusive) at the time of signing informed consent. 2. 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. 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 of any prescription drug within 21 days or 5 half-lives (whichever is longer) of study drug administration; or over-the-counter drug within 7 days or 5 half-lives (whichever is longer) of study drug administration. 6. Administration or use of any investigational drug or device within 30 days preceding the first does of study drug administration. 7. Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing. 8. Sensitivity to any of the study drugs, or components thereof, or drug or other allergy that in the opinion of the Investigator or Sponsor Medical Monitor, contraindicates participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
Contacts
CONTACTToll-Free Number
Outcome results
None listed