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
Mirador Therapeutics, Inc.
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
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.
Eligibility
- Age range
- 19–55 years
- Sex
- All
- 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 toba…
Interventions
- DrugMT-251
MT-251
Location
- Mirador Clinical DepartmentSan Diego, California