A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: LEO 138559; Drug: LEO 138559 Placebo

• Registration Number: NCT05099133
• Lead Sponsor: LEO Pharma

Brief Summary

This trial will investigate the pharmacokinetics, immunogenicity, safety, and tolerability of LEO 138559 in healthy Japanese subjects.

The trial consists of a screening period of up to 4 weeks, a single treatment with either LEO 138559 or placebo, and 8 follow-up visits to Day 85.

A total of 24 healthy subjects will be enrolled in 3 dose groups (n=8 per dose group) and randomized to either LEO 138559 or placebo in a ratio of 6:2.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-10-29
• Study Start: 2021-11-03
• Primary Completion: 2022-06-28
• Study Completion: 2022-06-28
• Status Verified: 2022-07
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEO 138559 Dose 1	LEO 138559	LEO 138559 will be administered subcutaneously up to 3 injections per dosing
LEO 138559 Dose 2	LEO 138559	LEO 138559 will be administered subcutaneously up to 3 injections per dosing
LEO 138559 Dose 3	LEO 138559	LEO 138559 will be administered subcutaneously up to 3 injections per dosing
Placebo	LEO 138559 Placebo	LEO 138559 placebo will be administered subcutaneously up to 3 injections per dosing

Primary Outcome Measures

Name	Time	Method
Vz/F: apparent volume of distribution	From Day 1 to Day 85	Pharmacokinetic endpoint to be determined from serum concentrations
AUC0-last: the area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration	From Day 1 to Day 85	Pharmacokinetic endpoint to be determined from serum concentrations
AUC0-inf: area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time	From Day 1 to Day 85	Pharmacokinetic endpoint to be determined from serum concentrations
Cmax: maximum serum LEO 138559 concentration	From Day 1 to Day 85	Pharmacokinetic endpoint to be determined from serum concentrations
tmax: time of maximum serum LEO 138559 concentration	From Day 1 to Day 85	Pharmacokinetic endpoint to be determined from serum concentrations
t½: terminal elimination half-life	From Day 1 to Day 85	Pharmacokinetic endpoint to be determined from serum concentrations
CL/F: apparent total body clearance	From Day 1 to Day 85	Pharmacokinetic endpoint to be determined from serum concentrations

Secondary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events	From Day 1 to Day 85
Presence of binding anti-drug antibodies	Day 1(pre-dose), Day 29, Day 57, and Day 85

Trial Locations

Locations (1)

LEO Investigational Site; 🇺🇸 Los Angeles, California, United States