NL-OMON51621
Withdrawn
Not Applicable
A Phase 1, first-in-human, three-part, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SAR443726 in healthy adult participants and in adult participants with moderate-to-severe atopic dermatitis. - Safety, tolerability, PK and PD of SAR443726
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- Sanofi-aventis
- Enrollment
- 15
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Confirmed diagnosis of moderate\-to\-severe AD for at least 1 year prior to
- •first administration of IMP on Day 1
- •\- Quantiferon® \- tuberculosis (TB) Gold test must be negative with no prior
- •history of documented tuberculosis irrespective of treatment.
- •\- Eczema Area and Severity Index (EASI) score \* 12 at screening and \* 16 at
- •\- Validated IGA score of at least 3 or 4 at Baseline
- •\- Atopic dermatitis involvement of \*10% of BSA at Baseline
- •\- Normal or clinically acceptable vital signs, standard 12\-lead ECG parameters,
- •laboratory parameters within the normal range
- •\- Body weight between 50\.0 and 105\.0 kg, inclusive, if male, and between 45\.0
Exclusion Criteria
- •\- Presence of dermatologic diseases other than AD that are susceptible to
- •interfere with clinical assessment of AD.
- •\- Co\-morbid clinically significant disease that might interfere with the
- •evaluation of IMP (eg. but not limited to: uncontrolled diabetes, severe
- •hypertension, severe ischemic heart disease, unstable angina in the last 6
- •months, unstable cardiac arrhythmias, and Class IV heart failure, renal,
- •hepatic or pulmonary disease, neurological condition, cancer any type).
- •Controlled hypertension under stable (unchanged in the last 6 months) treatment
- •with 1 antihypertensive is allowed.
- •\- Evidence of acute or chronic infection requiring treatment with
Outcomes
Primary Outcomes
Not specified
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