- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02596217
Safety, Tolerability and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Healthy Asian and Caucasian Male Volunteers
July 5, 2017 updated by: AbbVie
Safety, Tolerability, and Pharmacokinetics of Single Rising s.c. (Stage 1) and i.v. (Stage 2) Doses of BI 655066/ABBV-066 (Risankizumab) in Healthy Asian and Caucasian Male Volunteers (Double-blind, Randomized, Placebo-controlled Within Dose Groups)
Safety, tolerability and pharmacokinetics of single dose of BI 655066/ABBV-066 (risankizumab) in healthy Chinese, Japanese and Caucasian male volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokyo, Sumida-ku, Japan
- Boehringer Ingelheim Investigational Site
-
-
-
-
-
Busan, Korea, Republic of
- Boehringer Ingelheim Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion criteria:
- Healthy male subjects according to the investigator¿s assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Chinese ethnicity, Japanese ethnicity, or Caucasian according to the following criteria:
- Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in china
- Japanese; born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan
- Caucasian
- Age of 20 to 45 years (incl.)
- BMI of 18.5 to 25 kg/m2 (incl.) for Chinese and Japanese subjects, BMI of 18.5 to 29.9 kg/m2 (incl.) for Caucasian subjects.
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
Male subjects who agree to minimize the risk of female partners becoming pregnant by fulfilling any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:
- Use of adequate contraception, e.g. any of the following methods plus condom: implants, combined oral or vaginal contraceptives, intrauterine device
- Sexually abstinent
- Vasectomised (vasectomy at least 1 year prior to enrolment)
- Surgically sterilised (including hysterectomy)
Exclusion criteria:
- Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections including HIV, viral hepatitis and (or) tuberculosis or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold (or T-SPOT) test. Subjects with a positive QuantiFERON TB-Gold (or T-SPOT) test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines.
- History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
- Intake of biologic agents other than current study medication or drugs considered likely to interfere with the safe conduct of the study
- Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
- Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
- Participation in another trial with an investigational drug within 90 days or 5 half-lives (whichever is greater) prior to planned administration of trial medication
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking on specified trial days
- Alcohol abuse (consumption of more than 30 g per day)
- Drug abuse or positive drug screening
- Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
- Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening
- A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
- Have received any live bacterial or live viral vaccination in the 12 weeks prior to the date of screening. Subjects must agree not to receive a live bacterial or live viral vaccination during the study and up to 12 months after the last administration of study drug
- Have received Bacille Calmette-Guerin (BCG) vaccination in the 12 months prior to the date of screening. Subjects must agree not to receive BCG vaccination during the study and up to 12 months after the last administration of study drug
- Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stage 1 (low dose SC)
Low dose administered by subcutaneous (SC) injection
|
SC injection
Other Names:
IV infusion
Other Names:
|
Experimental: Stage 1 (medium dose SC)
Medium dose administered by subcutaneous (SC) injection
|
SC injection
Other Names:
IV infusion
Other Names:
|
Experimental: Stage 1 (high dose SC)
High dose administered by subcutaneous (SC) injection
|
SC injection
Other Names:
IV infusion
Other Names:
|
Experimental: Stage 2 (low dose IV)
Low dose administered by intraveneous (IV) infusion
|
SC injection
Other Names:
IV infusion
Other Names:
|
Experimental: Stage 2 (medium dose IV)
Medium dose administered by intraveneous (IV) infusion
|
SC injection
Other Names:
IV infusion
Other Names:
|
Experimental: Stage 2 (high dose IV)
High dose administered by intraveneous (IV) infusion
|
SC injection
Other Names:
IV infusion
Other Names:
|
Placebo Comparator: Placebo SC (Stage1)
Placebo administered by subcutaneous (SC) injection
|
SC injection (stage 1)
IV infusion (stage 2)
|
Placebo Comparator: Placebo IV (Stage2)
Placebo administered by intraveneous (IV) infusion
|
SC injection (stage 1)
IV infusion (stage 2)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of subjects with drug-related adverse events
Time Frame: Up to 144 days after screening
|
Up to 144 days after screening
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time from dosing to the maximum plasma concentration of the analyte in plasma (tmax)
Time Frame: Up to 144 days after randomization
|
Up to 144 days after randomization
|
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of the last quantifiable plasma concentration (AUC0-tz)
Time Frame: Up to 144 days after randomization
|
Up to 144 days after randomization
|
Maximum measured plasma concentration of the analyte in plasma (Cmax)
Time Frame: Up to 144 days after randomization
|
Up to 144 days after randomization
|
Terminal half-life of the analyte in plasma (t1/2)
Time Frame: Up to 144 days after randomization
|
Up to 144 days after randomization
|
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)
Time Frame: Up to 144 days after randomization
|
Up to 144 days after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Thakre N, D'Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Rheumatol Ther. 2022 Dec;9(6):1587-1603. doi: 10.1007/s40744-022-00495-0. Epub 2022 Sep 30.
- Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2015
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
August 12, 2015
First Submitted That Met QC Criteria
November 3, 2015
First Posted (Estimate)
November 4, 2015
Study Record Updates
Last Update Posted (Actual)
July 6, 2017
Last Update Submitted That Met QC Criteria
July 5, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M16-513
- 1311.16 (Other Identifier: Boehringer Ingelheim)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on ABBV-066
-
AbbVieNo longer availableCrohn's Disease | Ulcerative Colitis (UC)
-
AbbVieCompletedPsoriasisUnited States, Australia, Austria, Belgium, Canada, Czechia, Finland, France, Germany, Japan, Korea, Republic of, Mexico, Poland, Portugal, Spain, Sweden, Taiwan
-
AbbVieCompletedA Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic DermatitisDermatitisUnited States, Australia, Canada, Japan, Puerto Rico
-
AbbVieCompleted
-
AbbVieCompleted
-
AbbVieCompletedHealthy VolunteersUnited States
-
AbbVieBoehringer IngelheimCompleted
-
AbbVieBoehringer IngelheimCompleted
-
AbbVieActive, not recruitingPsoriatic Arthritis (PsA)United States, Argentina, Australia, Belgium, Brazil, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Sweden, United...