A Phase 1 interventional study of UCB7858 and Placebo in Healthy Volunteers, sponsored by UCB Biopharma S.P.R.L.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-21.
Sponsored by UCB Biopharma S.P.R.L. (part of UCB S.A.) · Phase 1, Interventional, and Basic science
This study is designed to evaluate the safety and tolerability of UCB7858 when given as single ascending doses administered by intravenous or subcutaneous infusion in healthy 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.
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Exclusion Criteria:
For subjects enrolled in the cohorts where the skin biopsies will be performed (Cohort 7 onward), the following exclusion criteria will also apply:
Various single doses, administered to various cohorts.
Drug: UCB7858
Single dose placebo comparator for each cohort of iv administration.
Drug: Placebo
Various single doses, administered to various cohorts.
Drug: UCB7858
Single dose placebo comparator for each cohort of sc administration.
Drug: Placebo
Incidence of adverse events following administration of UCB7858
Time frame: Cohort 1-10: Day 1 up to Day 72 Cohort 11: Day 1 up to Day 120
Maximum plasma concentration (Cmax)
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Time to reach Cmax (tmax)
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Area under the curve from time 0 to time t, the time of last quantifiable concentration [AUC(0-t)]
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Area under the curve from 0 to infinity (AUC)
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
The terminal plasma half-life (t1/2) following intravenous administration
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Plasma clearance (CL) of UCB7858 following intravenous administration
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Volume of distribution (Vss) for UCB7858 at steady state following intravenous administration
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Apparent volume of distribution (Vss/F) of UCB7858 following subcutaneous administration
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Apparent plasma clearance (CL/F) of UCB7858 following subcutaneous administration
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Mean absolute bioavailability (F) of UCB7858 given subcutaneously, using the ratio of geometric mean AUCs for subcutaneous (sc) administration and intravenous (iv) infusion (AUC_sc/AUC_iv)
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Concentration of UCB7858 at the end of infusion (Cinf)
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Time at the end of infusion of UCB7858 (tinf)
Time frame: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Plan to share: No — Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
No publications or documents are linked to this record.
Ran from Jul 2016 to primary completion in Jan 2018, 18 months.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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