A Study of Subcutaneous KY1005 in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Immune System Diseases
• Intervention / Treatment: Drug: KY1005

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Hammersmith Medicines Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Serum anti-KY1005 antibody titres	Baseline to day 92
Incidence of anti-KY1005 antibodies	Baseline to day 92

Collaborators and Investigators

• Sponsor: Kymab Limited
• Investigators: Principal Investigator: Adeep Puri, MBBS JCPTGP MPhil, Hammersmith Medicines Research

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases
• Other Study ID Numbers: KY1005-CT04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No