Healthy Male VolunteersPhase 1NCT03464227
A Study to Test the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects
A Phase 1 study testing UCB0107 in people with Healthy Male Volunteers, run by UCB Biopharma S.P.R.L. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- UCB0107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- 16 Feb 2018to 1 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Male Volunteers
- Being tested
- UCB0107, Placebo
- Keywords
- Phase 1, UCB0107
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB0107Drug
- Pharmaceutical form: solution for infusion
- Route of administration: intravenous use
PlaceboOther
- Pharmaceutical form: intravenous infusion
- Route of administration: intravenous use
| Study group | Role | What they receive |
|---|---|---|
| UCB0107 | Experimental | 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. Receives: Drug: UCB0107 |
| Placebo | Placebo comparator | Subjects randomized to this arm will receive matching Placebo to UCB0107. This arm will consist of a maximum of 7 cohorts. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Adverse Events (AEs) during the study
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.
Measured: During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20)
Secondary outcomes (8)
The Maximum concentration (Cmax) for UCB0107 in serum and cerebrospinal fluid
Cmax: maximum observed serum concentration
Measured: 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
AUC: area under the concentration-time curve from time 0 to infinity
Measured: 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
AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration
Measured: 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
tmax: time to maximum observed serum concentration
Measured: 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
t1/2: terminal half-life
Measured: 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
CL: clearance
Measured: 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
Vz: volume of distribution.
Measured: Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
CSF/serum ratio of antibody concentrations
Ratio of the antibody concentrations in cerebrospinal fluid and serum
Measured: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start16 Feb 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464227
- Sponsor's protocol ID
- UP0047
- Other IDs
- 2017-003315-19, 2017
- Status last verified
- Dec 2018
- First submitted
- 22 Feb 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03464227
- Acronym / sponsor ID
- UP0047
- Conditions
- Healthy Male Volunteers
- Keywords
- Phase 1, UCB0107
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCB0107 | Experimental | Drug: UCB0107Subjects 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. |
| Placebo | Placebo comparator | Other: PlaceboSubjects randomized to this arm will receive matching Placebo to UCB0107. This arm will consist of a maximum of 7 cohorts. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCB0107* Pharmaceutical form: solution for infusion * Route of administration: intravenous use | Drug | UCB0107 |
| Placebo* Pharmaceutical form: intravenous infusion * Route of administration: intravenous use | Other | Placebo |
Primary outcome
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.
8 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UCB0107 in people with Healthy Male Volunteers, run by UCB Biopharma S.P.R.L. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.