Immune System Diseases
Conditions
Brief summary
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.
Interventions
DRUGKY1005
A human anti-OX40 ligand monoclonal antibody
Sponsors
Kymab Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male, aged 18-45 years at screening * Body weight 60-120 kg * Body mass index (BMI) in the range 18.0-30.0 kg/m\^2 (inclusive) * Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs and laboratory tests of blood and urine
Exclusion criteria
* Clinically relevant abnormal findings at the screening assessment; acute or chronic illness; clinically relevant abnormal medical history or concurrent medical condition; positive tests for hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV) * Drug or alcohol abuse * Use of over-the-counter medication (with the exception of paracetamol \[acetaminophen\]) during the 7 days before the first dose of trial medication, or prescribed medication during the 28 days before first dose of trial medication * Participation in other clinical trials of unlicensed medicines within the 3 months or 5 half-lives, whichever is longer, before admission to this study * Loss of more than 400 mL blood, within the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-normalised AUC0-inf (AUC0-inf/D) following s.c. and i.v. administration | 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 | 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) | Baseline to day 92 |
| Occurrence of TEAE | Baseline to day 92 |
| Occurrence of TESAE | Baseline to day 92 |
| Occurrence of local injection site reactions | 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 |
Other
| Measure | Time frame |
|---|---|
| Serum anti-KY1005 antibody titres | Baseline to day 92 |
| Incidence of anti-KY1005 antibodies | Baseline to day 92 |
Countries
United Kingdom
Outcome results
None listed