NL-OMON51974
Completed
Not Applicable
A clinical trial to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of LEO 153339 in healthy subjects - A single and multiple ascending dose trial of LEO 153339 in healthy adults
eo Pharma A/S0 sites134 target enrollmentTBD
ConditionsPsoriasis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psoriasis
- Sponsor
- eo Pharma A/S
- Enrollment
- 134
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adult males and females.
- •Age between 18 and 65 years (both inclusive) at screening.
- •A body mass index (BMI) between 18\.0 and 32\.0 kg/m2 (both inclusive).
- •In good health at screening and/or check\-in (Day \-2 and Day \-1\) as judged by
- •the investigator based on medical history, physical examination, vital signs,
- •12 lead ECG, and clinical laboratory evaluations.
Exclusion Criteria
- •Male subjects sexually active with a woman of childbearing potential who are
- •not willing to use a barrier method of contraception (e.g. condom) from the
- •time of first dose of IMP until 3 months after the last dose, in conjunction
- •with this female partner using a highly effective form of contraception. For
- •vasectomised male subjects, male subjects with a female partner with bilateral
- •tubal occlusion or ligation, and heterosexually abstinent male subjects (when
- •this is in line with the
- •preferred and usual life style of the subject and not just being without a
- •current partner), no additional contraception is required.
- •Female subjects who are pregnant, lactating, or of childbearing potential
Outcomes
Primary Outcomes
Not specified
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