Healthy Volunteer
Conditions
Keywords
Phase 1, MT-201
Brief summary
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MT-201 Administered with Concomitant Infliximab in Healthy Participants
Interventions
DRUGMT-201
MT-201 and Infliximab
Sponsors
Mirador Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female (of non-childbearing potential only) between 19 and 55 years of age inclusive, at the time of signing informed consent. 2. Females must be of non-childbearing potential and must have undergone sterilization procedures, 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. 4. Good general health. 5. 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 Participants with non-SAEs and SAES | Up to 8 weeks 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