A First-in-Human Single and Multiple Ascending Dose Study of MT-251
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MT-251.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 19 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug MT-251
MT-251
Primary outcome measures
- Number of Subjects with non-SAEs and SAES [Time frame: Up to 14 days post dose.]
Eligibility criteria
Inclusion criteria
- 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.
- Good general health.
- Able to provide written informed consent and understand and comply with the requirements of the study.
Exclusion criteria
- 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.
- 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.
- Administration or use of any investigational drug or device within 30 days preceding the first does of study drug administration.
- Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mirador Clinical Department — San Diego
Identifiers
NCT: NCT07423299 · MT-251-101