NCT05682352

Investigating the Safety of LEO 158968 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Single- And Multiple Ascending Dose Trial To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Leo 158968 In Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate what side effects the new compound LEO 158968 might cause and how well it is tolerated when it is used by healthy participants. It will also investigate how quickly and to what extent LEO 158968 is distributed and eliminated from the body and if LEO 158968 causes the body to make antibodies. In the single ascending dose (SAD) cohorts, participants will receive escalating doses of LEO 158968 if the safety and tolerability results of the initial participants up to 48 hours (or 4 days for SC dosing) following dosing are acceptable to the Investigator. In the multiple ascending dose (MAD) cohorts, the dose of LEO 158968 will be determined based on results derived from the earlier SAD cohorts and additional preclinical data from a 5-week good laboratory practice (GLP) cynomolgus monkey toxicology study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	LEO 158968	IV infusion or SC injection
DRUG	Placebo	IV infusion or SC injection
DRUG	LEO 158968	SC injection
DRUG	Placebo	SC injection

Timeline

• Start date: 2023-02-07
• Primary completion: 2024-05-07
• Completion: 2024-08-01
• First posted: 2023-01-12
• Last updated: 2025-06-18

Locations

1 site across 1 country: Netherlands