This is an open-label, randomized, parallel design study to evaluate the PK comparability,
safety, tolerability and immunogenicity of a single SC dose of 360 mg CC 93538 using two
different drug concentrations, 180 mg/mL and 150 mg/mL, in healthy adult subjects.
A total of approximately 52 subjects will be enrolled and randomized 1:1 to receive a single
360 mg SC dose of CC-93538 using either 180 mg/mL (1 injection of 2 mL) or 150 mg/mL (2
injections of 1.2 mL each) drug concentrations.
Anaheim Clinical Trials, Anaheim, California, United States
This is an open-label, randomized, parallel design study to evaluate the PK, safety,
tolerability and immunogenicity of single SC doses of CC-93538 in healthy Japanese and
Caucasian adult subjects.
A total of approximately 48 subjects, 24 Japanese and 24 Caucasians, will be enrolled.
Japanese subjects will be enrolled first and randomized 1:1 to receive a single SC dose of
either 180 mg or 360 mg CC-93538. Caucasian subjects will then be enrolled and matched to
Japanese subjects (1:1) by weight (± 20%) and receive the same single SC dose of either 180
mg or 360 mg CC-93538.
Mayo Clinic - Arizona, Scottsdale, Arizona, United States
The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment
of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of
double-blind treatment and 52 weeks of open-label extension.