Overview
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
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