A first–in-human study to evaluate safety and tolerability of repeated topical administrations of BPR277 ointment in healthy volunteers, and safety, tolerability, and preliminary efficacy of multiple topical administrations of BPR277 in patients with atopic dermatitis and Netherton syndrome

ovartis Pharma Services AG0 sites85 target enrollmentJuly 18, 2011

Overview

No summary available.

Registry

who.int

Start Date

July 18, 2011

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects eligible for inclusion in this study have to fulfill all of the following criteria. Other protocol\-defined inclusion criteria apply in addition to those listed hereafter:
•1\.Written informed consent must be obtained before any assessment is performed.
•2\.Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health
•3\.Subjects must weigh at least 50kg to participate in the study, and must have a body mass index (BMI) within the range of 18\-35kg/m2\.
•4\.Study subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study.
•1\.Written informed consent must be obtained before any assessment is performed.
•2\.Male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
•3\.Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months (must have)
•Plus three or more of the following:
•History of involvement of the skin creases

•Subjects fulfilling any of the following criteria are not eligible for inclusion in this study. Other protocol\-defined exclusion criteria apply in addition to those listed hereafter:
•1\.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half\-lives of enrollment, whichever is longer.
•2\.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
•3\.A history of clinically significant ECG abnormalities, or ECG abnormalities at Screening or Baseline.
•4\.History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
•5\.Use of any prescription drugs, herbal supplements, within four (4\) weeks prior to initial dosing, and/or over\-the\-counter (OTC) medication, dietary supplements (vitamins included) within two (2\) weeks prior to initial dosing.
•6\.Total WBC count which falls outside the range of 4500–11,000/µl, or platelets \<100,000/µl, or hemoglobin levels below 12\.0 g/dl at screening.
•7\.Donation or loss of 400 ml or more of blood within eight (8\) weeks prior to initial dosing, or longer if required by local regulation.
•8\.Recent and/or recurrent history of autonomic dysfunction
•9\.Liver disease or liver injury as indicated by abnormal liver function tests