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

December 11, 2018 updated by: UCB Biopharma S.P.R.L.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Up0047 001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
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
Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
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
Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
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
Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
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
Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
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
Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
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.
Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
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
Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Biopharma S.P.R.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UP0047
  • 2017-003315-19 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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