A Phase 1 interventional study of UCB0107 and Placebo in Healthy Male Volunteers, sponsored by UCB Biopharma S.P.R.L.. Completed at 1 site in Germany. Open to male participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-12.
Sponsored by UCB Biopharma S.P.R.L. (part of UCB S.A.) · Phase 1, Interventional, and Basic science
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.
UCB Biopharma S.P.R.L. is the lead sponsor of 48 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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: solution for infusion * Route of administration: intravenous use
* Pharmaceutical form: intravenous infusion * Route of administration: intravenous use
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.
Time frame: During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20)
The Maximum concentration (Cmax) for UCB0107 in serum and cerebrospinal fluid
Cmax: maximum observed serum concentration
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
AUC: area under the concentration-time curve from time 0 to infinity
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
AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration
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
tmax: time to maximum observed serum concentration
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
t1/2: terminal half-life
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
CL: clearance
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
Vz: volume of distribution.
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
Ratio of the antibody concentrations in cerebrospinal fluid and serum
Time frame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
Ran from Feb 2018 to primary completion in Dec 2018, 9 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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