Safety and PK of Multiple Doses of MT1988

Monument Therapeutics Limited42 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteer

Interventions

MT1988DRUG

Active Drug

PlaceboDRUG

Placebo comparator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

BDD Pharma Ltd

Glasgow, United Kingdom

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events

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

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

Secondary Outcomes

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

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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