inflammatory diseases
Conditions
Interventions
SAD part:
Group A1, Day 1, LEO 158968 5 mg or placebo, once, Intravenous infusion
Group A2, Day 1, LEO 158968 10 mg or less, or placebo, once, Intravenous
infusion
Group A3, Day 1, LEO 158968 15 mg o
Sponsors
Leo Pharma
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Age: 18 to 60 years, inclusive, at screening Sex: Male or female Body mass index: 18.0 kg/m2 to 32.0 kg/m2, 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.
Exclusion criteria
Exclusion criteria: 1. Male subjects 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 subjects who are pregnant, lactating, or planning to become pregnant during the time of the trial. 3. Subjects with any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug. 4. Positive polymerase chain reaction (PCR) test for COVID-19 at 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of single and multiple ascending intravenous (iv) and subcutaneous (sc) doses of LEO 158968 administrated to healthy subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics (PK) of LEO 158968, administered to healthy subjects To monitor potential development of antidrug antibodies (ADA) after LEO 158968 dosing in healthy subjects | — |
Countries
Netherlands
Outcome results
None listed