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A Study to Evaluate Safety and Tolerability of Single Ascending Doses of Rozanolixizumab Administered by Subcutaneous Infusion in Healthy Japanese and Healthy Caucasian Study Participants

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ClinicalTrials.gov Identifier: NCT03859219
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief Summary:
The purpose of the study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of rozanolixizumab in japanese and caucasian healthy-volunteer study participants.

Condition or disease Intervention/treatment Phase
Healthy-volunteers Drug: Rozanolixizumab Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study Comparing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of Rozanolixizumab in Japanese and Caucasian Healthy-Volunteer Study Participants
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: Dose 1 of rozanolixizumab in Japanese subjects
Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
Drug: Rozanolixizumab
  • Pharmaceutical form: solution for injection
  • Route of administration: subcutaneous infusion

Experimental: Dose 2 of rozanolixizumab in Japanese subjects
Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
Drug: Rozanolixizumab
  • Pharmaceutical form: solution for injection
  • Route of administration: subcutaneous infusion

Experimental: Dose 3 of rozanolixizumab in Japanese subjects
Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
Drug: Rozanolixizumab
  • Pharmaceutical form: solution for injection
  • Route of administration: subcutaneous infusion

Experimental: Dose 1 of rozanolixizumab in Caucasian subjects
Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
Drug: Rozanolixizumab
  • Pharmaceutical form: solution for injection
  • Route of administration: subcutaneous infusion

Experimental: Dose 2 of rozanolixizumab in Caucasian subjects
Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
Drug: Rozanolixizumab
  • Pharmaceutical form: solution for injection
  • Route of administration: subcutaneous infusion

Experimental: Dose 3 of rozanolixizumab in Caucasian subjects
Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
Drug: Rozanolixizumab
  • Pharmaceutical form: solution for injection
  • Route of administration: subcutaneous infusion

Placebo Comparator: Placebo in Japanese subjects
Japanese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding.
Drug: Placebo
  • Pharmaceutical form: solution for injection
  • Route of administration: subcutaneous infusion

Placebo Comparator: Placebo in Caucasian subjects
Caucasian subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding.
Drug: Placebo
  • Pharmaceutical form: solution for injection
  • Route of administration: subcutaneous infusion




Primary Outcome Measures :
  1. Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Japanese [ Time Frame: From Baseline until Safety Follow-up (up to Week 8) ]
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  2. Plasma concentration of rozanolixizumab in healthy Japanese [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    Blood samples will be taken to assess the plasma concentration of rozanolixizumab.

  3. Maximum observed plasma concentration (Cmax) of rozanolixizumab in healthy Japanese [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    Maximum observed plasma concentration (Cmax)

  4. Time to maximum observed plasma concentration (tmax) of rozanolixizumab in healthy Japanese [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    Time of observed Cmax (tmax)

  5. Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of rozanolixizumab in healthy Japanese [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    AUC(0-t): Area under the curve from time 0 to time t, the time of last quantifiable concentration


Secondary Outcome Measures :
  1. Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Caucasian [ Time Frame: From Baseline until Safety Follow-up (up to Week 8) ]
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  2. Plasma concentration of rozanolixizumab in healthy Caucasian [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    Blood samples will be taken to assess the plasma concentration of rozanolixizumab.

  3. Maximum observed plasma concentration (Cmax) of rozanolixizumab in healthy Caucasian [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    Maximum observed plasma concentration (Cmax)

  4. Time to maximum observed plasma concentration (tmax) of rozanolixizumab in healthy Caucasian [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    Time of observed Cmax (tmax)

  5. Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of rozanolixizumab in healthy Caucasian [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    AUC(0-t): Area under the curve from time 0 to time t, the time of last quantifiable concentration

  6. AUC(0-t)/BW: Body weight normalized AUC(0-t) of rozanolixizumab [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    AUC(0-t)/BW: Body weight normalized AUC(0-t) of rozanolixizumab in Japanese and Caucasian healthy study participants

  7. AUC(0-t)/D: Dose normalized AUC(0-t) [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    AUC(0-t)/D: Dose normalized AUC(0-t) of rozanolixizumab in Japanese and Caucasian healthy study participants

  8. AUC(0-t)/D/BW: Dose and body weight normalized AUC(0-t) [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    AUC(0-t)/D/BW: Dose and body weight normalized AUC(0-t) of rozanolixizumab in Japanese and Caucasian healthy study participants

  9. Cmax/BW: Body weight normalized Cmax of rozanolixizumab [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    Cmax/BW: Body weight normalized Cmax of rozanolixizumab in Japanese and Caucasian healthy study participants

  10. Cmax/D: Dose normalized Cmax [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    Cmax/D: Dose normalized Cmax of rozanolixizumab in Japanese and Caucasian healthy study participants

  11. Cmax/D/BW: Dose and body weight normalized Cmax in Japanese and Caucasian study participants [ Time Frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours ]
    Cmax/D/BW: Dose and body weight normalized Cmax of rozanolixizumab in Japanese and Caucasian healthy study participants



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Study participant must be 18 to 65 years of age, inclusive, at the time of signing the Informed Consent form (ICF)
  • Study participants who are overtly healthy in the opinion of the investigator as determined by medical history and a general clinical examination, including physical examination, laboratory tests, and cardiac monitoring
  • Study participant must be considered reliable and capable of adhering to the protocol, according to the judgment of the investigator, and is able to communicate satisfactorily with the investigator and comply with all clinical study requirements
  • Japanese study participant is of Japanese descent, determined by verbal confirmation of familial heritage with all 4 grandparents of Japanese descent
  • Caucasian study participant is of Caucasian descent as evidenced in appearance and verbal confirmation of familial heritage with all 4 grandparents of Caucasian descent
  • Study participant is of normal weight as determined by a body mass index (BMI) between 18 and 32 kg/m2, inclusive, with a body weight of at least 50 kg (male) or 45 kg (female) and no greater than 100 kg

Exclusion Criteria:

  • Any medical (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could harm the study participant or would compromise the study participant's ability to participate in this study.
  • History of known inflammatory bowel disease, active diverticular disease, or a history of confirmed duodenal, gastric, or esophageal ulceration in the previous 6 months
  • Significant allergies to humanized monoclonal antibodies
  • Known hypersensitivity to any components of the investigational medicinal product (IMP)
  • Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities
  • Study participant is splenectomized, or has a clinically relevant active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to study treatment
  • Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
  • Received a vaccination within 8 weeks prior to Day -1; or intends to have a vaccination during the course of the study. Prior/Concurrent clinical study experience
  • Exposure to more than 3 new chemical entities within 12 months prior to dosing
  • Previously participated in this clinical study or has previously been assigned to treatment in a clinical study of IMP under investigation in this clinical study
  • Participated in another study of an IMP (or a medical device) within the previous 90 days or 5 half-lives prior to Day -1 (whichever is longer) or is currently participating in another study of an IMP (or a medical device)

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): NCT03859219


Contacts
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Contact: UCB Cares +1844599 ext 2273 UCBCares@ucb.com

Locations
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United Kingdom
UP0060 1 Recruiting
London, United Kingdom
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)

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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03859219     History of Changes
Other Study ID Numbers: UP0060
2018-004485-34 ( EudraCT Number )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Rozanolixizumab
Caucasian healthy-volunteers
Japanese healthy-volunteers
Phase 1
UCB7665