Status:
COMPLETED
A Study of Subcutaneous KY1005 in Healthy Volunteers
Lead Sponsor:
Kymab Limited
Conditions:
Immune System Diseases
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04449939
Start Date
July 7 2020
End Date
November 30 2020
Last Update
September 30 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hammersmith Medicines Research
London, United Kingdom