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Completed

NCT Number: NCT03464227

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

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.

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Key information

Conditions

Healthy Male Volunteers

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Up0047 001

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UCB0107

Drug
  • Pharmaceutical form: solution for infusion
  • Route of administration: intravenous use

Placebo

Other
  • Pharmaceutical form: intravenous infusion
  • Route of administration: intravenous use

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2018
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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