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A Study to Test the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT03464227
Recruitment Status : Completed
First Posted : March 13, 2018
Last Update Posted : December 12, 2018
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 of single ascending doses of UCB0107 administered by intravenous (iv) infusion in healthy male subjects.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Subject-Blind, Investigator-Blind, Randomized, Placebo-Controlled, First-in-Human Study to Evaluate Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects
Actual Study Start Date : February 16, 2018
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Arm Intervention/treatment
Experimental: UCB0107
Subjects randomized to this arm will receive UCB0107. This arm will consist of a maximum of 7 cohorts. The dose for cohort 1 will be fixed, proposed doses for cohorts 2,3,4,5,6 and 7 may be adapted based upon recommendation by the Safety Review Group.
Drug: UCB0107
  • Pharmaceutical form: solution for infusion
  • Route of administration: intravenous use

Placebo Comparator: Placebo
Subjects randomized to this arm will receive matching Placebo to UCB0107. This arm will consist of a maximum of 7 cohorts.
Other: Placebo
  • Pharmaceutical form: intravenous infusion
  • Route of administration: intravenous use




Primary Outcome Measures :
  1. The incidence of Adverse Events (AEs) during the study [ Time Frame: During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20) ]
    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 (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.


Secondary Outcome Measures :
  1. The Maximum concentration (Cmax) for UCB0107 in serum and cerebrospinal fluid [ Time Frame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) ]
    Cmax: maximum observed serum concentration

  2. The area under the concentration-time curve from time 0 to infinity (AUC) in serum and cerebrospinal fluid [ Time Frame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) ]
    AUC: area under the concentration-time curve from time 0 to infinity

  3. The area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration (AUC(0-t)) in serum and cerebrospinal fluid [ Time Frame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) ]
    AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration

  4. The time to maximum concentration (tmax) for UCB0107 in serum and cerebrospinal fluid [ Time Frame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) ]
    tmax: time to maximum observed serum concentration

  5. The terminal half-life (t½) of UCB0107 in serum [ Time Frame: Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20) ]
    t1/2: terminal half-life

  6. The total Clearance (CL) for UCB0107 in serum [ Time Frame: Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20) ]
    CL: clearance

  7. The volume of distribution (Vz) for UCB0107 in serum [ Time Frame: Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20) ]
    Vz: volume of distribution.

  8. CSF/serum ratio of antibody concentrations [ Time Frame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) ]
    Ratio of the antibody concentrations in cerebrospinal fluid and serum



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is male, >= 18 and <= 75 years of age
  • Subject has a body mass index (BMI) >= 18.0 and < 30.0 kg/m^2, with a body weight of at least 50 kg and maximum 100 kg
  • Subject is in good physical and mental health
  • Subject has clinical laboratory test results within the reference ranges of the laboratory
  • Subject's electrocardiogram (ECG) is considered "normal," or "abnormal" but clinically non-significant (as interpreted by the investigator)
  • Male subject confirms that, during the study period and for a period of 6 months or 5 half-lives of the investigational medicinal product (IMP) (whichever is longer), when having sexual intercourse with a woman of childbearing potential, a method of efficient contraception will be used, including a barrier AND an additional highly effective contraceptive method by the female partner

Exclusion Criteria:

  • Subject is an employee or direct relative of an employee of the contract research organization (CRO) or UCB
  • Subject has previously been assigned to treatment in this study or in another study of the medication under investigation in this study
  • Subject is considered to be a vulnerable participant
  • Subject has had major surgery (including joint surgery) within 6 months prior to Screening, or has planned surgery within 6 months after study treatment
  • Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 4 weeks before the first dose of 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): NCT03464227


Locations
Germany
Up0047 001
Berlin, Germany
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares 001 844 599 2273 (UCB)

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03464227     History of Changes
Other Study ID Numbers: UP0047
2017-003315-19 ( EudraCT Number )
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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. ):
Phase 1
UCB0107