Clinical trial NCT04449939: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune System Diseases
Lead sponsor: Kymab Limited
Sponsor class: INDUSTRY
First posted: 2020-06-29
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum observed concentration (Cmax) after infusion
timeFrame: Baseline to day 92
measure: Time at which Cmax is observed after infusion (tmax)
timeFrame: Baseline to day 92
measure: Area under the concentration time curve from time 0 to last observation (AUC 0-t)
timeFrame: Baseline to day 92
measure: Area under the concentration time curve from time 0 to infinity (AUC0-inf)
timeFrame: Baseline to day 92
measure: Systemic clearance after i.v. infusion (CL)
timeFrame: Baseline to day 92
measure: Apparent systemic clearance after s.c. injection (CL/F)
timeFrame: Baseline to day 92
measure: Volume of distribution during the terminal phase after i.v. infusion (Vz)
timeFrame: Baseline to day 92
measure: Apparent volume of distribution after s.c. injection (Vz/F)
timeFrame: Baseline to day 92
measure: Steady-state volume of distribution after i.v. infusion (Vss)
timeFrame: Baseline to day 92
measure: Weight-normalised Vss and Vz
timeFrame: Baseline to day 92
measure: Half-life t½
timeFrame: Baseline to day 92
measure: Dose-normalised Cmax (Cmax/D) following s.c. and i.v. administration
timeFrame: Baseline to day 92
measure: Absolute bioavailability (F) calculated as the ratio of AUC0-inf/D after i.v. and s.c. infusion
timeFrame: Baseline to day 92
measure: Dose-normalised AUC0-inf (AUC0-inf/D) following s.c. and i.v. administration
timeFrame: Baseline to day 92
Secondary outcomes:
measure: Occurrence of TEAE
timeFrame: Baseline to day 92
measure: Occurrence of TESAE
timeFrame: Baseline to day 92
measure: Occurrence of local injection site reactions
timeFrame: Baseline to day 92
measure: Changes in blood pressure mmHg (as a measure of safety and tolerability)
timeFrame: Baseline to day 92
measure: Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability)
timeFrame: Baseline to day 92
measure: Changes in heart rate bpm (as a measure of safety and tolerability)
timeFrame: Baseline to day 92
measure: Changes in tympanic temperature °C (as a measure of safety and tolerability)
timeFrame: Baseline to day 92
measure: Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability)
timeFrame: Baseline to day 92
Other outcomes:
measure: Serum anti-KY1005 antibody titres
timeFrame: Baseline to day 92
measure: Incidence of anti-KY1005 antibodies
timeFrame: Baseline to day 92
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
Study officials:
affiliation: Hammersmith Medicines Research
name: Adeep Puri, MBBS JCPTGP MPhil
role: PRINCIPAL_INVESTIGATOR
References: