Healthy Volunteer
Conditions
Keywords
Phase I
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.
Interventions
DRUGMT1988
Active Drug
DRUGPlacebo
Placebo comparator
Sponsors
Monument Therapeutics Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed