A Study of Subcutaneous KY1005 in Healthy Volunteers

Immune System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449939
• Other study ID #: KY1005-CT04
• Status: Completed
• Phase: Phase 1
• Start date: July 7, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2021
• Source: Kymab Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune System Diseases

Intervention

Drug:
• KY1005
A human anti-OX40 ligand monoclonal antibody

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Kymab Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum anti-KY1005 antibody titres		Baseline to day 92
Other	Incidence of anti-KY1005 antibodies		Baseline to day 92
Primary	Maximum observed concentration (Cmax) after infusion		Baseline to day 92
Primary	Time at which Cmax is observed after infusion (tmax)		Baseline to day 92
Primary	Area under the concentration time curve from time 0 to last observation (AUC 0-t)		Baseline to day 92
Primary	Area under the concentration time curve from time 0 to infinity (AUC0-inf)		Baseline to day 92
Primary	Systemic clearance after i.v. infusion (CL)		Baseline to day 92
Primary	Apparent systemic clearance after s.c. injection (CL/F)		Baseline to day 92
Primary	Volume of distribution during the terminal phase after i.v. infusion (Vz)		Baseline to day 92
Primary	Apparent volume of distribution after s.c. injection (Vz/F)		Baseline to day 92
Primary	Steady-state volume of distribution after i.v. infusion (Vss)		Baseline to day 92
Primary	Weight-normalised Vss and Vz		Baseline to day 92
Primary	Half-life t½		Baseline to day 92
Primary	Dose-normalised Cmax (Cmax/D) following s.c. and i.v. administration		Baseline to day 92
Primary	Absolute bioavailability (F) calculated as the ratio of AUC0-inf/D after i.v. and s.c. infusion		Baseline to day 92
Primary	Dose-normalised AUC0-inf (AUC0-inf/D) following s.c. and i.v. administration		Baseline to day 92
Secondary	Occurrence of TEAE		Baseline to day 92
Secondary	Occurrence of TESAE		Baseline to day 92
Secondary	Occurrence of local injection site reactions		Baseline to day 92
Secondary	Changes in blood pressure mmHg (as a measure of safety and tolerability)		Baseline to day 92
Secondary	Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability)		Baseline to day 92
Secondary	Changes in heart rate bpm (as a measure of safety and tolerability)		Baseline to day 92
Secondary	Changes in tympanic temperature °C (as a measure of safety and tolerability)		Baseline to day 92
Secondary	Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability)		Baseline to day 92