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The purpose of this study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Dose A IRL201104 or placebo | Experimental | IRL201104 IV once daily for 5 days OR Placebo IV once daily for 5 days |
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| Group 2: Dose B IRL201104 or placebo | Experimental | IRL201104 IV once daily for 7 days OR Placebo IV once daily for 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRL201104 | Drug | lyophilised powder for reconstitution for IV dosing |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with TEAEs and number of events will be summarised by treatment | Adverse Events after treatment administration will be collected at baseline and repeated until study completion | 33 (group 1) or 35 (group 2) days |
| Number of subjects with potentially clinically important (PCI) abnormal haematology variables will be summarised by treatment | Haemoglobin, haematocrit, MCV, MCH, MCHC, RBC, WBC and differentials will be collected at baseline and after dose administration and repeated until Day 19 or 21 | 19 (group 1) or 21 (group 2) days |
| Number of subjects with PCI abnormal clinical chemistry variables will be summarised by treatment | Creatinine, glucose, triglycerides, urea, uric acid, bilirubin, cholesterol, sodium, potassium, alkaline phosphatase, AST, ALT and GGT will be collected at baseline and after dose administration and repeated until Day 19 or 21 | 19 (group 1) or 21 (group 2) days |
| Number of subjects with PCI and/or abnormal electrocardiogram variables will be summarised by treatment | RR, PR, QRS, QT-interval, QTcF and heart rate will be collected at baseline and after dose administration and repeated until Day 19 or 21. | 19 (group 1) or 21 (group 2) days |
| Number of subjects with PCI abnormal vital sign variables will be summarised by treatment | Blood pressure, pulse rate, oral body temperature and respiration rate will be collected at baseline and after single and multiple dose administration and repeated until Day 19 or 21 | 19 (group 1) or 21 (group 2) days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of IRL201104: Trough blood concentration (Ctrough) | Ctrough will be measured after multiple dosing | 5 (group 1) or 7 (group 2) days |
| PK of IRL201104: Maximum (peak) blood concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | United Kingdom |
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| ID | Term |
|---|---|
| C000714087 | IRL201104 |
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| Placebo | Drug | Matching placebo for IRL201104 |
|
Cmax will be calculated after multiple dosing
| 5 (group 1) or 7 (group 2) days |
| PK of IRL201104: Terminal half life (t1/2) | t1/2 will be calculated after multiple dosing | 5 (group 1) or 7 (group 2) days |
| PK of IRL201104: Area under the curve from time zero to last quantifiable concentration of IRL201104 (AUCt) | AUCt will be calculated after multiple dosing | 5 (group 1) or 7 (group 2) days |
| PK of IRL201104: Apparent total body clearance from blood (CLss) | CLss will be calculated after multiple dosing | 5 (group 1) or 7 (group 2) days |
| PK of IRL201104: steady state volume of distribution (Vz) | Vz will be calculated after multiple dosing | 5 (group 1) or 7 (group 2) days |