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A Study of Subcutaneous KY1005 in Healthy Volunteers

Primary Purpose

Immune System Diseases

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

KY1005

About this trial

This is an interventional treatment trial for Immune System Diseases

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Hammersmith Medicines Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Single dose of KY1005 by i.v. infusion

Single lower dose KY1005 by s.c. injection

Single higher dose KY1005 by s.c. injections

Outcomes

Primary Outcome Measures

Maximum observed concentration (Cmax) after infusion

Time at which Cmax is observed after infusion (tmax)

Area under the concentration time curve from time 0 to last observation (AUC 0-t)

Area under the concentration time curve from time 0 to infinity (AUC0-inf)

Systemic clearance after i.v. infusion (CL)

Apparent systemic clearance after s.c. injection (CL/F)

Volume of distribution during the terminal phase after i.v. infusion (Vz)

Apparent volume of distribution after s.c. injection (Vz/F)

Steady-state volume of distribution after i.v. infusion (Vss)

Weight-normalised Vss and Vz

Half-life t½

Dose-normalised Cmax (Cmax/D) following s.c. and i.v. administration

Absolute bioavailability (F) calculated as the ratio of AUC0-inf/D after i.v. and s.c. infusion

Dose-normalised AUC0-inf (AUC0-inf/D) following s.c. and i.v. administration

Secondary Outcome Measures

Occurrence of TEAE

Occurrence of TESAE

Occurrence of local injection site reactions

Changes in blood pressure mmHg (as a measure of safety and tolerability)

Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability)

Changes in heart rate bpm (as a measure of safety and tolerability)

Changes in tympanic temperature °C (as a measure of safety and tolerability)

Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability)

Full Information

NCT ID

NCT04449939

First Posted

June 15, 2020

Last Updated

September 29, 2021

Sponsor

Kymab Limited

1. Study Identification

Unique Protocol Identification Number

NCT04449939

Brief Title

A Study of Subcutaneous KY1005 in Healthy Volunteers

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

July 7, 2020 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kymab Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune System Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Single dose of KY1005 by i.v. infusion

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Single lower dose KY1005 by s.c. injection

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Single higher dose KY1005 by s.c. injections

Intervention Type

Drug

Intervention Name(s)

KY1005

Intervention Description

A human anti-OX40 ligand monoclonal antibody

Primary Outcome Measure Information:

Title

Maximum observed concentration (Cmax) after infusion

Time Frame

Baseline to day 92

Title

Time at which Cmax is observed after infusion (tmax)

Time Frame

Baseline to day 92

Title

Area under the concentration time curve from time 0 to last observation (AUC 0-t)

Time Frame

Baseline to day 92

Title

Area under the concentration time curve from time 0 to infinity (AUC0-inf)

Time Frame

Baseline to day 92

Title

Systemic clearance after i.v. infusion (CL)

Time Frame

Baseline to day 92

Title

Apparent systemic clearance after s.c. injection (CL/F)

Time Frame

Baseline to day 92

Title

Volume of distribution during the terminal phase after i.v. infusion (Vz)

Time Frame

Baseline to day 92

Title

Apparent volume of distribution after s.c. injection (Vz/F)

Time Frame

Baseline to day 92

Title

Steady-state volume of distribution after i.v. infusion (Vss)

Time Frame

Baseline to day 92

Title

Weight-normalised Vss and Vz

Time Frame

Baseline to day 92

Title

Half-life t½

Time Frame

Baseline to day 92

Title

Dose-normalised Cmax (Cmax/D) following s.c. and i.v. administration

Time Frame

Baseline to day 92

Title

Absolute bioavailability (F) calculated as the ratio of AUC0-inf/D after i.v. and s.c. infusion

Time Frame

Baseline to day 92

Title

Dose-normalised AUC0-inf (AUC0-inf/D) following s.c. and i.v. administration

Time Frame

Baseline to day 92

Secondary Outcome Measure Information:

Title

Occurrence of TEAE

Time Frame

Baseline to day 92

Title

Occurrence of TESAE

Time Frame

Baseline to day 92

Title

Occurrence of local injection site reactions

Time Frame

Baseline to day 92

Title

Changes in blood pressure mmHg (as a measure of safety and tolerability)

Time Frame

Baseline to day 92

Title

Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability)

Time Frame

Baseline to day 92

Title

Changes in heart rate bpm (as a measure of safety and tolerability)

Time Frame

Baseline to day 92

Title

Changes in tympanic temperature °C (as a measure of safety and tolerability)

Time Frame

Baseline to day 92

Title

Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability)

Time Frame

Baseline to day 92

Other Pre-specified Outcome Measures:

Title

Serum anti-KY1005 antibody titres

Time Frame

Baseline to day 92

Title

Incidence of anti-KY1005 antibodies

Time Frame

Baseline to day 92

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adeep Puri, MBBS JCPTGP MPhil

Organizational Affiliation

Hammersmith Medicines Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hammersmith Medicines Research

City

London

Country

United Kingdom

12. IPD Sharing Statement

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A Study of Subcutaneous KY1005 in Healthy Volunteers

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