HealthyPhase 1NCT02596217
Safety, Tolerability and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Healthy Asian and Caucasian Male Volunteers
A Phase 1 study testing ABBV-066 in people with Healthy, run by AbbVie at 2 sites in 2 countries.
Trial summary
Safety, tolerability and pharmacokinetics of single dose of BI 655066/ABBV-066 (risankizumab) in healthy Chinese, Japanese and Caucasian male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ABBV-066
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2015to Jun 2017
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.)
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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)
Safety, tolerability and pharmacokinetics of single dose of BI 655066/ABBV-066 (risankizumab) in healthy Chinese, Japanese and Caucasian male volunteers.
- Conditions
- Healthy
- Being tested
- ABBV-066, Placebo
- Keywords
- ABBV-066, BI 655066, risankizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-066Drug
Also called BI 655066, risankizumab
SC injection
ABBV-066Drug
Also called BI 655066, risankizumab
IV infusion
PlaceboDrug
SC injection (stage 1)
PlaceboDrug
IV infusion (stage 2)
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 (low dose SC) | Experimental | Low dose administered by subcutaneous (SC) injection Receives: Drug: ABBV-066 |
| Stage 1 (medium dose SC) | Experimental | Medium dose administered by subcutaneous (SC) injection Receives: Drug: ABBV-066 |
| Stage 1 (high dose SC) | Experimental | High dose administered by subcutaneous (SC) injection Receives: Drug: ABBV-066 |
| Stage 2 (low dose IV) | Experimental | Low dose administered by intraveneous (IV) infusion Receives: Drug: ABBV-066 |
| Stage 2 (medium dose IV) | Experimental | Medium dose administered by intraveneous (IV) infusion Receives: Drug: ABBV-066 |
| Stage 2 (high dose IV) | Experimental | High dose administered by intraveneous (IV) infusion Receives: Drug: ABBV-066 |
| Placebo SC (Stage1) | Placebo comparator | Placebo administered by subcutaneous (SC) injection Receives: Drug: Placebo |
| Placebo IV (Stage2) | Placebo comparator | Placebo administered by intraveneous (IV) infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with drug-related adverse events
Measured: Up to 144 days after screening
Secondary outcomes (5)
Time from dosing to the maximum plasma concentration of the analyte in plasma (tmax)
Measured: 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)
Measured: Up to 144 days after randomization
Maximum measured plasma concentration of the analyte in plasma (Cmax)
Measured: Up to 144 days after randomization
Terminal half-life of the analyte in plasma (t1/2)
Measured: 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)
Measured: Up to 144 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596217
- Sponsor's protocol ID
- M16-513
- Other IDs
- 1311.16
- Status last verified
- Jul 2017
- First submitted
- 12 Aug 2015
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Thakre N, Goebel A, Winzenborg I, Suleiman AA, D'Cunha R, Mensing S, Liu W, Pang Y. Population Pharmacokinetic and Exposure-Response Modeling to Inform Risankizumab Dose Selection in Patients With Ulcerative Colitis. Clin Pharmacol Ther. 2024 Sep;116(3):847-857. doi: 10.1002/cpt.3330. Epub 2024 Jun 11.
PubMed 38863178Thakre 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.
PubMed 36178584Suleiman 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.
PubMed 31054118