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 9, 2013

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2013

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:
•Part 1 (healthy volunteers)
•Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health
•Part 2 (patients with atopic dermatitis):
•Male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
•Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months (must have) Plus three or more of the following:
•a. History of involvement of the skin creases
•b. Personal history of asthma or hay fever
•c. History of generally dry skin in the past year
•d. Onset before age of 2 years

•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:
•Part 1 (healthy volunteers):
•History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
•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.
•Part 2 (patients with atopic dermatitis):
•History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
•History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
•Pregnant or nursing (lactating) women.
•Women of child\-bearing potential must use highly effective contraception (as further defined in study protocol)
•Use of topical prescription treatment for eczema within 1 week prior to initial dosing of topical corticosteroids (TCS).