Skip to main content
OpenTrials
Completed

NCT Number: NCT06728176

Safety and PK of Multiple Doses of MT1988

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteer

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

BDD Pharma Ltd

Glasgow, G4 0SF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT1988

Drug

Active Drug

Placebo

Drug

Placebo comparator

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: 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 outcomes

  1. Pharmacokinetics of single dose of MT1988 across four dose levels - Cmax

    Time frame: Days 1-2

    Maximum plasma concentration (Cmax). Between-group comparisons will be made using descriptive statistics

  2. Pharmacokinetics of multiple doses of MT1988 across four dose levels - Cmax

    Time frame: Days 14 to 17

    Maximum plasma concentration (Cmax). Between-group comparisons will be made using descriptive statistics

  3. Pharmacokinetics of single doses of MT1988 across four dose levels - Tmax

    Time frame: Days 1-2

    Time to maximum plasma concentration (Tmax). Between-group comparisons will be made using descriptive statistics

  4. Pharmacokinetics of multiple doses of MT1988 across four dose levels - Tmax

    Time frame: Days 14 to 17

    Time to maximum plasma concentration (Tmax). Between-group comparisons will be made using descriptive statistics

  5. Pharmacokinetics of single doses of MT1988 across four dose levels - AUC

    Time frame: Days 1-2

    Total drug exposure (area under the curve (AUC))). Between-group comparisons will be made using descriptive statistics

  6. Pharmacokinetics of multiple doses of MT1988 across four dose levels - AUC

    Time frame: Days 14 to 17

    Total drug exposure (area under the curve (AUC))). Between-group comparisons will be made using descriptive statistics

Sponsors and collaborators

Lead sponsor

Monument Therapeutics Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.