Investigating the Safety of LEO 158968 in Healthy Volunteers
- Conditions
- Healthy Volunteers
- Registration Number
- NCT05682352
- Lead Sponsor
- LEO Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria:<br><br> 1. Age: 18 to 60 years, inclusive, at screening<br><br> 2. Sex: Male or female<br><br> 3. Body mass index: 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, at screening<br><br> 4. Health status: In good health as judged by the Investigator based on medical<br> history, physical examination, electrocardiogram (ECG), hematology, biochemistry,<br> and urinalysis.<br><br>Exclusion Criteria:<br><br>A participant who meets any of the following exclusion criteria will not be eligible for<br>inclusion in the study:<br><br> 1. Male participants sexually active with a woman of childbearing potential who are not<br> willing to use a barrier method of contraception (eg, condom) from the time of first<br> dose of investigational medicinal product (IMP) until 16 weeks after the last dose,<br> in conjunction with this female partner using a highly effective form of<br> contraception.<br><br> 2. Female participants who are pregnant, lactating, or planning to become pregnant<br> during the time of the trial.<br><br> 3. Participants with any surgical or medical condition which might significantly alter<br> the distribution, metabolism, or excretion of any drug.<br><br> 4. Positive polymerase chain reaction (PCR) test for coronavirus disease-19 (COVID-19)<br> on Day -1, or contact with COVID-19 positive (or suspected) persons within 14 days<br> prior to first dose.<br><br> 5. ECG with QT-interval corrected for heart rate (QTc) using Fridericia's formula<br> (QTcF) >450 msec for men, >460 msec for women, confirmed by repeat measurement at<br> screening.<br><br> 6. Treatment with any prescribed or nonprescribed systemic or topical medication within<br> 7 days prior to the first dose of IMP (excluding paracetamol; including herbal<br> remedies), unless, in the opinion of the Investigator and the Sponsor, the<br> medication will not interfere with the trial procedures or compromise safety.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Treatment-emergent Adverse Events (TEAEs) Reported for Each Participant
- Secondary Outcome Measures
Name Time Method Area Under the Serum Concentration-time Curve from Time 0 to Infinity (AUC0-8) of LEO 158968;Area Under the Serum Concentration-time Curve from 0 Hours to 168 Hours (AUC0-168h) of LEO 158968;Area Under the Serum Concentration-time Curve from t=0 to t (AUC0-t) of LEO 158968;Serum Concentration Observed at 168 Hours Post-dose (C168h) of LEO 158968;Maximum Observed Serum Concentration (Cmax) of LEO 158968;Apparent Terminal Half-life (t1/2) of LEO 158968;Time of Last Quantifiable Concentration (tlast) of LEO 158968;Time of Cmax (tmax) of LEO 158968;Area Under the Serum Concentration-time Curve Over the Dosing Interval t (ie, 168 hours) (AUCt) of LEO 158968;AUC0-t of LEO 158968;Trough Serum Concentration Observed at the End of a Dosing Interval (168 hours post-dose) (Ct) of LEO 158968;Cmax of LEO 158968;t1/2 of LEO 158968;tlast of LEO 158968;tmax of LEO 158968;Number of Participants with Antidrug Antibodies (ADA)