Safety and PK of Multiple Doses of MT1988

NCT ID: NCT06728176

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-25
• Study Completion Date: 2025-04-10

Brief Summary

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MT1988 Dose 1

MT1988 Dose Level 1 (oral, twice daily)

Group Type: EXPERIMENTAL

MT1988

Intervention Type: DRUG

Active Drug

MT1988 Dose 2

MT1988 Dose Level 2 (oral, twice daily)

Group Type: EXPERIMENTAL

MT1988

Intervention Type: DRUG

Active Drug

MT1988 Dose 3

MT1988 Dose Level 3 (oral, twice daily)

Group Type: EXPERIMENTAL

MT1988

Intervention Type: DRUG

Active Drug

MT1988 Dose 4

MT1988 Dose Level 4 (oral, twice daily)

Group Type: EXPERIMENTAL

MT1988

Intervention Type: DRUG

Active Drug

Placebo

Placebo (oral, twice daily)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo comparator

Interventions

MT1988

Active Drug

Intervention Type: DRUG

Placebo

Placebo comparator

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Monument Therapeutics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: PRINCIPAL_INVESTIGATOR

BDD Pharma

Locations

BDD Pharma Ltd

Glasgow, , United Kingdom

Countries

United Kingdom

Other Identifiers

SCZ103

Identifier Type: -

Identifier Source: org_study_id