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Safety, Tolerability and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Healthy Asian and Caucasian Male Volunteers

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ClinicalTrials.gov Identifier: NCT02596217
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie

Brief Summary:
Safety, tolerability and pharmacokinetics of single dose of BI 655066/ABBV-066 (risankizumab) in healthy Chinese, Japanese and Caucasian male volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: ABBV-066 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : August 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: Stage 1 (low dose SC)
Low dose administered by subcutaneous (SC) injection
Drug: ABBV-066
SC injection
Other Names:
  • BI 655066
  • risankizumab

Experimental: Stage 1 (medium dose SC)
Medium dose administered by subcutaneous (SC) injection
Drug: ABBV-066
SC injection
Other Names:
  • BI 655066
  • risankizumab

Experimental: Stage 1 (high dose SC)
High dose administered by subcutaneous (SC) injection
Drug: ABBV-066
SC injection
Other Names:
  • BI 655066
  • risankizumab

Experimental: Stage 2 (low dose IV)
Low dose administered by intraveneous (IV) infusion
Drug: ABBV-066
IV infusion
Other Names:
  • BI 655066
  • risankizumab

Experimental: Stage 2 (medium dose IV)
Medium dose administered by intraveneous (IV) infusion
Drug: ABBV-066
IV infusion
Other Names:
  • BI 655066
  • risankizumab

Experimental: Stage 2 (high dose IV)
High dose administered by intraveneous (IV) infusion
Drug: ABBV-066
IV infusion
Other Names:
  • BI 655066
  • risankizumab

Placebo Comparator: Placebo SC (Stage1)
Placebo administered by subcutaneous (SC) injection
Drug: Placebo
SC injection (stage 1)

Placebo Comparator: Placebo IV (Stage2)
Placebo administered by intraveneous (IV) infusion
Drug: Placebo
IV infusion (stage 2)




Primary Outcome Measures :
  1. Percentage of subjects with drug-related adverse events [ Time Frame: Up to 144 days after screening ]

Secondary Outcome Measures :
  1. Time from dosing to the maximum plasma concentration of the analyte in plasma (tmax) [ Time Frame: Up to 144 days after randomization ]
  2. 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 ]
  3. Maximum measured plasma concentration of the analyte in plasma (Cmax) [ Time Frame: Up to 144 days after randomization ]
  4. Terminal half-life of the analyte in plasma (t1/2) [ Time Frame: Up to 144 days after randomization ]
  5. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. 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
  2. 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
  3. Age of 20 to 45 years (incl.)
  4. 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.
  5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
  6. 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:

  1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
  2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  3. Any evidence of a concomitant disease judged as clinically relevant by the investigator
  4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  5. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
  6. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  7. History of relevant orthostatic hypotension, fainting spells, or blackouts
  8. 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.
  9. History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
  10. Intake of biologic agents other than current study medication or drugs considered likely to interfere with the safe conduct of the study
  11. 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
  12. 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
  13. 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
  14. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
  15. Inability to refrain from smoking on specified trial days
  16. Alcohol abuse (consumption of more than 30 g per day)
  17. Drug abuse or positive drug screening
  18. Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
  19. Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
  20. Inability to comply with dietary regimen of trial site
  21. 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
  22. A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
  23. 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
  24. 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
  25. 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

Information from the National Library of Medicine

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): NCT02596217


Locations
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Japan
Boehringer Ingelheim Investigational Site
Tokyo, Sumida-ku, Japan
Korea, Republic of
Boehringer Ingelheim Investigational Site
Busan, Korea, Republic of
Sponsors and Collaborators
AbbVie
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02596217    
Other Study ID Numbers: M16-513
1311.16 ( Other Identifier: Boehringer Ingelheim )
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Keywords provided by AbbVie:
ABBV-066
BI 655066
risankizumab
Additional relevant MeSH terms:
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Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs