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Investigating the Safety of LEO 158968 in Healthy Volunteers

LEO Pharma logo

LEO Pharma

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: LEO 158968
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05682352
LP0189-2242
U1111-1285-9850 (Other Identifier)
2022-002768-65 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

A participant who meets any of the following exclusion criteria will not be eligible for inclusion in the study:

  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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

120 participants in 2 patient groups

LEO 158968 Single Ascending Dose (SAD) Cohorts
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Drug: Placebo
Drug: LEO 158968
Drug: LEO 158968
LEO 158968 Multiple Ascending Dose (MAD) Cohorts
Experimental group
Description:
Participants will receive 5 once weekly (QW) doses of LEO 158968 or matching placebo via a SC injection.
Treatment:
Drug: Placebo
Drug: Placebo
Drug: LEO 158968
Drug: LEO 158968

Trial contacts and locations

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Central trial contact

Clinical Disclosure

Data sourced from clinicaltrials.gov

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