A Study of Subcutaneous KY1005 in Healthy Volunteers

Kymab

Status and phase: Completed; Phase 1

Conditions: Immune System Diseases

Treatments: Drug: KY1005

Study type: Interventional

Funder types: Industry

Identifiers

NCT04449939

KY1005-CT04

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Group 1

Experimental group

Description:

Single dose of KY1005 by i.v. infusion

Treatment:

Drug: KY1005

Group 2

Experimental group

Description:

Single lower dose KY1005 by s.c. injection

Treatment:

Drug: KY1005

Group 3

Experimental group

Description:

Single higher dose KY1005 by s.c. injections

Treatment:

Drug: KY1005