Safety and PK of Multiple Doses of MT1988

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Placebo; Drug: MT1988

• Registration Number: NCT06728176
• Lead Sponsor: Monument Therapeutics Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-25
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-11
• Status Verified: 2025-04
• Primary Completion: 2025-04-08
• Study Completion: 2025-04-10
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (oral, twice daily)
MT1988 Dose 1	MT1988	MT1988 Dose Level 1 (oral, twice daily)
MT1988 Dose 2	MT1988	MT1988 Dose Level 2 (oral, twice daily)
MT1988 Dose 3	MT1988	MT1988 Dose Level 3 (oral, twice daily)
MT1988 Dose 4	MT1988	MT1988 Dose Level 4 (oral, twice daily)

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	From Day 1 to end of follow up (Day 21-28)	Data will be analysed using descriptive statistics across four dose levels and versus placebo.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

BDD Pharma Ltd; 🇬🇧 Glasgow, United Kingdom