A Study of Subcutaneous KY1005 in Healthy Volunteers
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group 1 Single dose of KY1005 by i.v. infusion |
Drug: KY1005
A human anti-OX40 ligand monoclonal antibody
|
Experimental: Group 2 Single lower dose KY1005 by s.c. injection |
Drug: KY1005
A human anti-OX40 ligand monoclonal antibody
|
Experimental: Group 3 Single higher dose KY1005 by s.c. injections |
Drug: KY1005
A human anti-OX40 ligand monoclonal antibody
|
Outcome Measures
Primary Outcome Measures
- 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 [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]
Secondary Outcome Measures
- 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]
- Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability) [Baseline to day 92]
Other Outcome Measures
- Serum anti-KY1005 antibody titres [Baseline to day 92]
- Incidence of anti-KY1005 antibodies [Baseline to day 92]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hammersmith Medicines Research | London | United Kingdom |
Sponsors and Collaborators
- Kymab Limited
Investigators
- Principal Investigator: Adeep Puri, MBBS JCPTGP MPhil, Hammersmith Medicines Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY1005-CT04