A Study of Subcutaneous KY1005 in Healthy Volunteers

NCT04449939 | Completed Phase 1 DMC

• 1 other identifier: KY1005-CT04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune System Diseases

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (8)

• 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

Other Outcomes (2)

• Serum anti-KY1005 antibody titres

  Baseline to day 92

• Incidence of anti-KY1005 antibodies

  Baseline to day 92

Study Arms (3)

Group 1

EXPERIMENTAL

Single dose of KY1005 by i.v. infusion

Drug: KY1005

Group 2

EXPERIMENTAL

Single lower dose KY1005 by s.c. injection

Drug: KY1005

Group 3

EXPERIMENTAL

Single higher dose KY1005 by s.c. injections

Drug: KY1005

Interventions

KY1005 DRUG

A human anti-OX40 ligand monoclonal antibody

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kymab Limited: lead

Study Sites (1)

Hammersmith Medicines Research

London, United Kingdom

Location

MeSH Terms

Conditions

Immune System Diseases

Study Officials

• Adeep Puri, MBBS JCPTGP MPhil

  Hammersmith Medicines Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 29, 2020
• Study Start: July 7, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

GB (1)