Investigating the Safety of LEO 158968 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-07

Study Completion Date

2024-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LEO 158968 Single Ascending Dose (SAD) Cohorts

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.

Group Type EXPERIMENTAL

LEO 158968

Intervention Type DRUG

IV infusion or SC injection

Placebo

Intervention Type DRUG

IV infusion or SC injection

LEO 158968 Multiple Ascending Dose (MAD) Cohorts

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

Group Type EXPERIMENTAL

LEO 158968

Intervention Type DRUG

SC injection

Placebo

Intervention Type DRUG

SC injection

Interventions

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LEO 158968

IV infusion or SC injection

Intervention Type DRUG

Placebo

IV infusion or SC injection

Intervention Type DRUG

LEO 158968

SC injection

Intervention Type DRUG

Placebo

SC injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Female participants who are pregnant, lactating, or planning to become pregnant during the time of the trial.
3. Participants with any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of any drug.
4. 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.
5. 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.
6. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes