A Study of Subcutaneous KY1005 in Healthy Volunteers
- Registration Number
- NCT04449939
- Lead Sponsor
- Kymab Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3 KY1005 Single higher dose KY1005 by s.c. injections Group 1 KY1005 Single dose of KY1005 by i.v. infusion Group 2 KY1005 Single lower dose KY1005 by s.c. injection
- Primary Outcome Measures
Name Time Method 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 Half-life t½ 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 Dose-normalised Cmax (Cmax/D) following s.c. and i.v. administration Baseline to day 92 Dose-normalised AUC0-inf (AUC0-inf/D) following s.c. and i.v. administration Baseline to day 92 Apparent systemic clearance after s.c. injection (CL/F) 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 Weight-normalised Vss and Vz 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 Systemic clearance after i.v. infusion (CL) Baseline to day 92
- Secondary Outcome Measures
Name Time Method 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 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 Occurrence of TESAE Baseline to day 92 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 Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability) Baseline to day 92
Trial Locations
- Locations (1)
Hammersmith Medicines Research
🇬🇧London, United Kingdom