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COMPLETED
NCT05682352
PHASE1

Investigating the Safety of LEO 158968 in Healthy Volunteers

Sponsor: LEO Pharma

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-02-07

Completion Date

2024-08-01

Last Updated

2026-04-28

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

LEO 158968

IV infusion or SC injection

DRUG

Placebo

IV infusion or SC injection

DRUG

LEO 158968

SC injection

DRUG

Placebo

SC injection

Locations (1)

LEO Pharma Investigational Site

Groningen, Netherlands