Safety and PK of Multiple Doses of MT1988

A Single Centre, Double Blinded, Randomised, Parallel Arm, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of MT1988 in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Placebo; Drug: MT1988

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G4 0SF
    • BDD Pharma Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT1988 Dose 1; MT1988 Dose Level 1 (oral, twice daily)	Drug: MT1988; Active Drug
Experimental: MT1988 Dose 2; MT1988 Dose Level 2 (oral, twice daily)	Drug: MT1988; Active Drug
Experimental: MT1988 Dose 3; MT1988 Dose Level 3 (oral, twice daily)	Drug: MT1988; Active Drug
Experimental: MT1988 Dose 4; MT1988 Dose Level 4 (oral, twice daily)	Drug: MT1988; Active Drug
Placebo Comparator: Placebo; Placebo (oral, twice daily)	Drug: Placebo; Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of single dose of MT1988 across four dose levels - Cmax	Maximum plasma concentration (Cmax). Between-group comparisons will be made using descriptive statistics	Days 1-2
Pharmacokinetics of multiple doses of MT1988 across four dose levels - Cmax	Maximum plasma concentration (Cmax). Between-group comparisons will be made using descriptive statistics	Days 14 to 17
Pharmacokinetics of single doses of MT1988 across four dose levels - Tmax	Time to maximum plasma concentration (Tmax). Between-group comparisons will be made using descriptive statistics	Days 1-2
Pharmacokinetics of multiple doses of MT1988 across four dose levels - Tmax	Time to maximum plasma concentration (Tmax). Between-group comparisons will be made using descriptive statistics	Days 14 to 17
Pharmacokinetics of single doses of MT1988 across four dose levels - AUC	Total drug exposure (area under the curve (AUC))). Between-group comparisons will be made using descriptive statistics	Days 1-2
Pharmacokinetics of multiple doses of MT1988 across four dose levels - AUC	Total drug exposure (area under the curve (AUC))). Between-group comparisons will be made using descriptive statistics	Days 14 to 17

Collaborators and Investigators

• Sponsor: Monument Therapeutics Limited
• Investigators: Principal Investigator: Medical Director, BDD Pharma

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Actual): April 8, 2025
• Study Completion (Actual): April 10, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Phase I
• Other Study ID Numbers: SCZ103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing of IPD is not appropriate for this Phase I commercial study in healthy volunteers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No