A Study of Subcutaneous KY1005 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Open-label Study to Assess the Pharmacokinetics of KY1005 After Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Volunteers

Conditions
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Immune System Diseases

Intervention / Treatment
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* Drug: KY1005


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Single dose of KY1005 by i.v. infusion | Drug: KY1005<br>* A human anti-OX40 ligand monoclonal antibody<br>|
| Experimental: Group 2<br>Single lower dose KY1005 by s.c. injection | Drug: KY1005<br>* A human anti-OX40 ligand monoclonal antibody<br>|
| Experimental: Group 3<br>Single higher dose KY1005 by s.c. injections | Drug: KY1005<br>* A human anti-OX40 ligand monoclonal antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |