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Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after subcutaneous (s.c.) and intravenous (i.v.) administration, with i.v. KY1005 as a reference treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Single dose of KY1005 by i.v. infusion |
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| Group 2 | Experimental | Single lower dose KY1005 by s.c. injection |
|
| Group 3 | Experimental | Single higher dose KY1005 by s.c. injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KY1005 | Drug | A human anti-OX40 ligand monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) after infusion | Baseline to day 92 | |
| Time at which Cmax is observed after infusion (tmax) | Baseline to day 92 | |
| Area under the concentration time curve from time 0 to last observation (AUC 0-t) | Baseline to day 92 | |
| Area under the concentration time curve from time 0 to infinity (AUC0-inf) | Baseline to day 92 | |
| Systemic clearance after i.v. infusion (CL) | Baseline to day 92 | |
| Apparent systemic clearance after s.c. injection (CL/F) | Baseline to day 92 | |
| Volume of distribution during the terminal phase after i.v. infusion (Vz) | Baseline to day 92 | |
| Apparent volume of distribution after s.c. injection (Vz/F) | Baseline to day 92 | |
| Steady-state volume of distribution after i.v. infusion (Vss) | Baseline to day 92 | |
| Weight-normalised Vss and Vz | Baseline to day 92 | |
| Half-life t½ |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of TEAE | Baseline to day 92 | |
| Occurrence of TESAE | Baseline to day 92 | |
| Occurrence of local injection site reactions |
| Measure | Description | Time Frame |
|---|---|---|
| Serum anti-KY1005 antibody titres | Baseline to day 92 | |
| Incidence of anti-KY1005 antibodies | Baseline to day 92 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adeep Puri, MBBS JCPTGP MPhil | Hammersmith Medicines Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | United Kingdom |
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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after s.c. and i.v. administration, with i.v. KY1005 as a reference treatment.
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| Baseline to day 92 |
| Dose-normalised Cmax (Cmax/D) following s.c. and i.v. administration | Baseline to day 92 |
| Absolute bioavailability (F) calculated as the ratio of AUC0-inf/D after i.v. and s.c. infusion | Baseline to day 92 |
| Dose-normalised AUC0-inf (AUC0-inf/D) following s.c. and i.v. administration | Baseline to day 92 |
| Baseline to day 92 |
| Changes in blood pressure mmHg (as a measure of safety and tolerability) | Baseline to day 92 |
| Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) | Baseline to day 92 |
| Changes in heart rate bpm (as a measure of safety and tolerability) | Baseline to day 92 |
| Changes in tympanic temperature °C (as a measure of safety and tolerability) | Baseline to day 92 |
| Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) | Baseline to day 92 |