A First-in-Human Single and Multiple Ascending Dose Study of MT-201

Mirador Therapeutics, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: MT-201; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07219368

MT-201-101

Details and patient eligibility

About

First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in healthy participants.

Enrollment: 72 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male participant or female participant of nonchildbearing potential 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 participants with female partners of childbearing potential who are involved in heterosexual intercourse or activities that could lead to pregnancy must use barrier method of contraception (male condom) and refrain from sperm donation.
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 or use of any investigational drug or device within 30 days preceding the first dose of study drug administration.
6. Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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72 participants in 4 patient groups, including a placebo group

Single Ascending Dose of MT-201

Experimental group

Description:

To assess the safety and tolerability of single intravenous/subcutaneous doses of MT-201

Treatment:

Drug: MT-201

Multiple Ascending Dose of MT-201

Experimental group

Description:

To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-201

Treatment:

Drug: MT-201

Single Ascending Dose Placebo Arm

Placebo Comparator group

Description:

To assess the safety and tolerability of single intravenous/subcutaneous doses of placebo

Treatment:

Drug: Placebo

Multiple Ascending Dose Placebo

Placebo Comparator group

Description:

To assess the safety and tolerability of multiple intravenous/subcutaneous doses of placebo

Treatment:

Drug: Placebo