Safety and PK of Multiple Doses of MT1988

NCT06728176 | Completed Phase 1

• 1 other identifier: SCZ103
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Phase I

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events

  Data will be analysed using descriptive statistics across four dose levels and versus placebo.

  From Day 1 to end of follow up (Day 21-28)

Secondary Outcomes (6)

• Pharmacokinetics of single dose of MT1988 across four dose levels - Cmax

  Days 1-2

• Pharmacokinetics of multiple doses of MT1988 across four dose levels - Cmax

  Days 14 to 17

• Pharmacokinetics of single doses of MT1988 across four dose levels - Tmax

  Days 1-2

• Pharmacokinetics of multiple doses of MT1988 across four dose levels - Tmax

  Days 14 to 17

• Pharmacokinetics of single doses of MT1988 across four dose levels - AUC

  Days 1-2

Study Arms (5)

MT1988 Dose 1

EXPERIMENTAL

MT1988 Dose Level 1 (oral, twice daily)

Drug: MT1988

MT1988 Dose 2

EXPERIMENTAL

MT1988 Dose Level 2 (oral, twice daily)

Drug: MT1988

MT1988 Dose 3

EXPERIMENTAL

MT1988 Dose Level 3 (oral, twice daily)

Drug: MT1988

MT1988 Dose 4

EXPERIMENTAL

MT1988 Dose Level 4 (oral, twice daily)

Drug: MT1988

Placebo

PLACEBO COMPARATOR

Placebo (oral, twice daily)

Drug: Placebo

Interventions

MT1988 DRUG

Active Drug

MT1988 Dose 1; MT1988 Dose 2; MT1988 Dose 3; MT1988 Dose 4

Placebo DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monument Therapeutics Limited: lead

Study Sites (1)

BDD Pharma Ltd

Glasgow, G4 0SF, United Kingdom

Location

Study Officials

• Medical Director

  BDD Pharma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 11, 2024
• Study Start: November 25, 2024
• Primary Completion: April 8, 2025
• Study Completion: April 10, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)