A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT02039063|
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: E6011 2 mg/kg Drug: E6011 5 mg/kg Drug: E6011 10 mg/kg Drug: E6011 15 mg/kg||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease|
|Actual Study Start Date :||March 14, 2014|
|Actual Primary Completion Date :||January 6, 2017|
|Actual Study Completion Date :||November 27, 2017|
E6011 2 mg/kg
Drug: E6011 2 mg/kg
E6011 5 mg/kg
Drug: E6011 5 mg/kg
E6011 10 mg/kg
Drug: E6011 10 mg/kg
E6011 15 mg/kg
Drug: E6011 15 mg/kg
- Adverse events (AEs) as a measure of safety and tolerability [ Time Frame: Baseline and Week 12 ]Safety assessments include the following: AEs, laboratory test values (vasculitis marker), vital signs, body weight, physical examination, neurological examination, ECG, and chest x-ray.
- Laboratory assessments as a measure of safety and tolerability [ Time Frame: Baseline and Week 12 ]Clinical laboratory assessments will include hematology, clinical chemistry, urinalysis and other screening tests.
- Vital signs as a measure of safety and tolerability [ Time Frame: Baseline and Week 12 ]Vital sign measurements will include systolic and diastolic blood pressure (BP) and pulse rate.
- Electrocardiogram (ECG) as a measure of safety and tolerability [ Time Frame: Baseline and Week 12 ]Twelve-lead ECGs will be obtained as a measure of safety and tolerability.
- Pharmacokinetics (PK) profiles of repeated intravenous administration of E6011 [ Time Frame: Baseline and Week 12 ]PK parameters including area under the concentration-time curve (AUC) and maximum blood concentrations (Cmax), half life (T1/2), time to Cmax (Tmax) following repeated intravenous administration of E6011.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039063
|Nagoya, Aichi, Japan|
|Chikushino, Fukuoka, Japan|
|Kurume, Fukuoka, Japan|
|Asahikawa, Hokkaido, Japan|
|Nishinomiya, Hyogo, Japan|
|Kanazawa, Ishikawa, Japan|
|Morioka, Iwate, Japan|
|Sagamihara, Kanagawa, Japan|
|Tsu, Mie, Japan|
|Urazoe, Okinawa, Japan|
|Takatsuki, Osaka, Japan|
|Minato-ku, Tokyo, Japan|
|Shinjuku-ku, Tokyo, Japan|