Safety and PK of Multiple Doses of MT1988

Monument Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: MT1988

Study type: Interventional

Funder types: Industry

Identifiers

NCT06728176

SCZ103

Details and patient eligibility

About

The goal of this clinical trial is to assess the tolerability and amount of drug in the blood when four dose levels of MT1988 are administered for 14 days to healthy volunteers. The main question it aims to answer is:

• what side effects are seen while administering MT1988 for 14 days?
• how much of MT1988 can be measured in the blood at the beginning and end of administering MT1988 for 14 days?

Researchers will include a placebo arm (dummy drug) to compare the side effects.

Participants will:

• take MT1988 every day for 14 days
• visit the clinic once per week for assessments
• keep a diary to record information between clinic appointments.

Enrollment: 42 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers
• providing informed consent
• for females of child-bearing potential with fertile male partner - willing to comply with contraception requirements

Exclusion criteria

• no current or past condition which may compromise the study objectives or participant safety
• no clinically significant finding at screening, including physical examination, blood tests, medical history, concomitant medication
• history of drug abuse or dependence within the previous 2 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 5 patient groups, including a placebo group

MT1988 Dose 1

Experimental group

Description:

MT1988 Dose Level 1 (oral, twice daily)

Treatment:

Drug: MT1988

MT1988 Dose 2

Experimental group

Description:

MT1988 Dose Level 2 (oral, twice daily)

Treatment:

Drug: MT1988

MT1988 Dose 3

Experimental group

Description:

MT1988 Dose Level 3 (oral, twice daily)

Treatment:

Drug: MT1988

MT1988 Dose 4

Experimental group

Description:

MT1988 Dose Level 4 (oral, twice daily)

Treatment:

Drug: MT1988

Placebo

Placebo Comparator group

Description:

Placebo (oral, twice daily)

Treatment:

Drug: Placebo