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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04449939
Other study ID # KY1005-CT04
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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