Investigating the Safety of LEO 158968 in Healthy Volunteers

NCT05682352 | Completed Phase 1

• 3 other identifiers: LP0189-22422022-002768-65U1111-1285-9850
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Healthy Volunteers; LEO 158968

Outcome Measures

Primary Outcomes (1)

• Number of Treatment-emergent Adverse Events (TEAEs) Reported for Each Participant

  Any clinically significant changes from baseline in clinical laboratory parameters, vital signs including systolic and diastolic blood pressure, and abnormal clinically significant findings from physical examinations following first dose will be recorded as TEAEs.

  Day 1 to Day 113

Secondary Outcomes (16)

• Area Under the Serum Concentration-time Curve from Time 0 to Infinity (AUC0-∞) of LEO 158968

  Day 1 to Day 85

• Area Under the Serum Concentration-time Curve from 0 Hours to 168 Hours (AUC0-168h) of LEO 158968

  Day 1 to Day 85

• Area Under the Serum Concentration-time Curve from t=0 to t (AUC0-t) of LEO 158968

  Day 1 to Day 85

• Serum Concentration Observed at 168 Hours Post-dose (C168h) of LEO 158968

  Day 1 to Day 85

• Maximum Observed Serum Concentration (Cmax) of LEO 158968

  Day 1 to Day 85

Study Arms (2)

LEO 158968 Single Ascending Dose (SAD) Cohorts

EXPERIMENTAL

Participants will receive a single dose of LEO 158968 or matching placebo via an intravenous (IV) infusion or subcutaneous (SC) injection. The dose of LEO 158968 will be increased per cohort.

Drug: LEO 158968; Drug: Placebo

LEO 158968 Multiple Ascending Dose (MAD) Cohorts

EXPERIMENTAL

Participants will receive 5 once weekly (QW) doses of LEO 158968 or matching placebo via a SC injection.

Drug: LEO 158968; Drug: Placebo

Interventions

LEO 158968 DRUG

IV infusion or SC injection

LEO 158968 Single Ascending Dose (SAD) Cohorts

Placebo DRUG

IV infusion or SC injection

LEO 158968 Single Ascending Dose (SAD) Cohorts

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 60 years, inclusive, at screening
• Sex: Male or female
• Body mass index: 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, at screening
• Health status: In good health as judged by the Investigator based on medical history, physical examination, electrocardiogram (ECG), hematology, biochemistry, and urinalysis.

You may not qualify if:

• Male participants sexually active with a woman of childbearing potential who are not willing to use a barrier method of contraception (eg, condom) from the time of first dose of investigational medicinal product (IMP) until 16 weeks after the last dose, in conjunction with this female partner using a highly effective form of contraception.
• Female participants who are pregnant, lactating, or planning to become pregnant during the time of the trial.
• Participants with any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of any drug.
• Positive polymerase chain reaction (PCR) test for coronavirus disease-19 (COVID-19) on Day -1, or contact with COVID-19 positive (or suspected) persons within 14 days prior to first dose.
• ECG with QT-interval corrected for heart rate (QTc) using Fridericia's formula (QTcF) \>450 msec for men, \>460 msec for women, confirmed by repeat measurement at screening.
• Treatment with any prescribed or nonprescribed systemic or topical medication within 7 days prior to the first dose of IMP (excluding paracetamol; including herbal remedies), unless, in the opinion of the Investigator and the Sponsor, the medication will not interfere with the trial procedures or compromise safety.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

LEO Pharma Investigational Site

Groningen, 9728, Netherlands

Location

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 12, 2023
• Study Start: February 7, 2023
• Primary Completion: May 7, 2024
• Study Completion: August 1, 2024
• Last Updated: April 28, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)