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
- Conditions
- inflammatory diseases10003816
- Registration Number
- NL-OMON53439
- Lead Sponsor
- eo Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of single and multiple ascending<br /><br>intravenous (iv) and subcutaneous (sc) doses of LEO 158968 administrated to<br /><br>healthy subjects</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the pharmacokinetics (PK) of LEO 158968, administered to healthy<br /><br>subjects<br /><br>To monitor potential development of antidrug antibodies (ADA) after LEO 158968<br /><br>dosing in healthy subjects</p><br>