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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:
Researchers will include a placebo arm (dummy drug) to compare the side effects.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT1988 Dose 1 | Experimental | MT1988 Dose Level 1 (oral, twice daily) |
|
| MT1988 Dose 2 | Experimental | MT1988 Dose Level 2 (oral, twice daily) |
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| MT1988 Dose 3 | Experimental | MT1988 Dose Level 3 (oral, twice daily) |
|
| MT1988 Dose 4 | Experimental | MT1988 Dose Level 4 (oral, twice daily) |
|
| Placebo | Placebo Comparator | Placebo (oral, twice daily) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT1988 | Drug | Active Drug |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | BDD Pharma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BDD Pharma Ltd | Glasgow | G4 0SF | United Kingdom |
Sharing of IPD is not appropriate for this Phase I commercial study in healthy volunteers
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| Placebo | Drug | Placebo comparator |
|
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 |