A Study of Subcutaneous KY1005 in Healthy Volunteers

• Status: Completed
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kymab Limited

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