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OpenTrials
Completed

NCT Number: NCT04449939

A Study of Subcutaneous KY1005 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.

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Key information

Conditions

Immune System Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KY1005

Drug

A human anti-OX40 ligand monoclonal antibody

Primary outcomes

  1. Maximum observed concentration (Cmax) after infusion

    Time frame: Baseline to day 92

  2. Time at which Cmax is observed after infusion (tmax)

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

  5. Systemic clearance after i.v. infusion (CL)

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

  10. Weight-normalised Vss and Vz

    Time frame: Baseline to day 92

  11. Half-life t½

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

Secondary outcomes

  1. Occurrence of TEAE

    Time frame: Baseline to day 92

  2. Occurrence of TESAE

    Time frame: Baseline to day 92

  3. Occurrence of local injection site reactions

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

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

    Time frame: Baseline to day 92

Other outcomes

  1. Serum anti-KY1005 antibody titres

    Time frame: Baseline to day 92

  2. Incidence of anti-KY1005 antibodies

    Time frame: Baseline to day 92

Sponsors and collaborators

Lead sponsor

Kymab Limited

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 29, 2020
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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