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A Study to Test the Safety and Tolerability and Pharmacokinetics of Single Doses of UCB0107 in Healthy Japanese Subjects

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ClinicalTrials.gov Identifier: NCT03605082
Recruitment Status : Completed
First Posted : July 30, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief Summary:
The purpose of the study is to evaluate the safety and tolerability and serum Pharmacokinetics (PK) of single doses of UCB0107 administered in healthy Japanese subjects.

Condition or disease Intervention/treatment Phase
Healthy Japanese Volunteers Drug: UCB0107 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-center, Investigator-blind, Subject Blind, Randomized, Placebo-controlled Study to Evaluate Safety and Tolerability and Pharmacokinetics of Single Doses of UCB0107 in Healthy Japanese Subjects
Actual Study Start Date : July 25, 2018
Actual Primary Completion Date : March 11, 2019
Actual Study Completion Date : March 11, 2019

Arm Intervention/treatment
Experimental: UCB0107
Subjects will be randomized to receive a predefined dosage of UCB0107 in order to maintain the blinding.
Drug: UCB0107
  • Pharmaceutical form: solution for infusion
  • Route of administration: intravenous use

Placebo Comparator: Placebo
Subjects will be randomized and receive a placebo in order to maintain the blinding.
Other: Placebo
  • Pharmaceutical form: solution for infusion
  • Route of administration: intravenous use




Primary Outcome Measures :
  1. The incidence of treatment-emergent adverse events during the study from first dose of UCB0107 to safety follow-up/withdraw [ Time Frame: From first dose of UCB0107 to safety follow-up/withdraw on day 140 +/-4 days ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

  2. Maximum observed serum concentration of UCB0107 during the study [ Time Frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140 ]

    Pharmacokinetic variable:

    Cmax: maximum observed serum concentration


  3. Area under the concentration-time curve from time 0 to infinity of UCB0107 during the study [ Time Frame: The blood samples for serum Pharmacokinetics will be taken from predose to Day 140 ]

    Pharmacokinetic variable:

    AUC: area under the concentration-time curve from time 0 to infinity


  4. Area under the concentration-time curve from time 0 to time t of UCB0107 during the study [ Time Frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140 ]

    Pharmacokinetic variable:

    AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration


  5. Terminal half-life of UCB0107 during the study [ Time Frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140 ]

    Pharmacokinetic variable:

    t1/2: terminal half-life


  6. Volume of distribution of UCB0107 during the study [ Time Frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140 ]

    Pharmacokinetic variable:

    Vz: volume of distribution


  7. The clearance of UCB0107 during the study [ Time Frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140 ]

    Pharmacokinetic variable:

    CL: clearance


  8. The time to maximum observed serum concentration of UCB0107 during the study [ Time Frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140 ]

    Pharmacokinetic variable:

    tmax: time to maximum observed serum concentration




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is male or female, >=20 and <=75 years of age
  • Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan)
  • Subject has a body mass index (BMI) >=18.0 and <=30.0 kg/m^2, with a body weight of at least 50 kilogram (kg) for males and 45 kg for females, and maximum 100 kg
  • Subject is in good physical and mental health, in particular is not affected by any neurological disorder, in the opinion of the Investigator, as determined on the basis of medical history and a general clinical examination at Screening
  • Subject has clinical laboratory test results within the reference ranges of the laboratory
  • Subject has Blood pressure and pulse rate within normal range in supine position after 5 minutes rest
  • Subject's electrocardiogram (ECG) is considered "normal," or "abnormal" but clinically nonsignificant (as interpreted by the Investigator)

Exclusion Criteria:

  • Subject has any clinically relevant abnormal findings in physical examination, laboratory tests, vital signs, or electrocardiogram, which, in the opinion of the Investigator, may place the subject at risk because of participation in the study
  • Subject has a history of recurrent headaches, including migraine
  • Subject has a history of alcohol and/or drug abuse up to 6 months before Screening
  • Subject smokes on average >5 cigarettes/day (or equivalent) during the last 3 months and is not able to stop smoking during the In-Clinic Period
  • Subject has any clinically relevant brain magnetic resonance imaging (MRI) abnormality at Screening
  • Subject has >upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%)
  • Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 2 years
  • Subject has a positive serology test for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at Screening
  • Subject has a known hypersensitivity to any components of the investigational medicinal product (IMP), comparative drugs, any biologic or small molecule, or concomitant medication as stated in this protocol
  • Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 6 months following the final dose of the IMP

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): NCT03605082


Locations
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United Kingdom
Up0065 001
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: NCT03605082     History of Changes
Other Study ID Numbers: UP0065
2018-000475-32 ( EudraCT Number )
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
UCB0107
Phase 1