Healthy
Conditions
Keywords
Healthy Volunteers, LEO 158968
Brief summary
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.
Interventions
DRUGLEO 158968
IV infusion or SC injection
DRUGPlacebo
IV infusion or SC injection
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) Reported for Each Participant | Day 1 to Day 113 | Any clinically significant changes from baseline in clinical laboratory parameters, vital signs including systolic and diastolic blood pressure, and abnormal clinically significant findings from physical examinations following first dose will be recorded as TEAEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Serum Concentration-time Curve from Time 0 to Infinity (AUC0-∞) of LEO 158968 | Day 1 to Day 85 | — |
| Area Under the Serum Concentration-time Curve from 0 Hours to 168 Hours (AUC0-168h) of LEO 158968 | Day 1 to Day 85 | — |
| Area Under the Serum Concentration-time Curve from t=0 to t (AUC0-t) of LEO 158968 | Day 1 to Day 85 | Where t corresponds to the last observed quantifiable concentration calculated by the linear up - logarithmic down trapezoidal rule. |
| Serum Concentration Observed at 168 Hours Post-dose (C168h) of LEO 158968 | Day 1 to Day 85 | — |
| Maximum Observed Serum Concentration (Cmax) of LEO 158968 | Day 1 to Day 85 | — |
| Apparent Terminal Half-life (t1/2) of LEO 158968 | Day 1 to Day 85 | — |
| Time of Last Quantifiable Concentration (tlast) of LEO 158968 | Day 1 to Day 85 | — |
| Time of Cmax (tmax) of LEO 158968 | Day 1 to Day 85 | — |
| Area Under the Serum Concentration-time Curve Over the Dosing Interval τ (ie, 168 hours) (AUCτ) of LEO 158968 | Day 1 to Day 113 | — |
| AUC0-t of LEO 158968 | Day 1 to Day 113 | — |
| Trough Serum Concentration Observed at the End of a Dosing Interval (168 hours post-dose) (Cτ) of LEO 158968 | Day 1 to Day 113 | — |
| Cmax of LEO 158968 | Day 1 to Day 113 | — |
| t1/2 of LEO 158968 | Day 1 to Day 113 | — |
| tlast of LEO 158968 | Day 1 to Day 113 | — |
| tmax of LEO 158968 | Day 1 to Day 113 | — |
| Number of Participants with Antidrug Antibodies (ADA) | Day 1 to Day 113 | — |
Countries
Netherlands
Contacts
STUDY_DIRECTORMedical Expert
LEO Pharma
Outcome results
None listed