ClinicalTrials.gg
CompletedNCT02879877Updated Aug 21, 2019

A First-In-Human Study With a Single Ascending Dose of UCB7858 in Healthy Volunteers

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

Phase
Phase 1
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • First in human
  • subjects
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Healthy male and female volunteers who gave their written consent by signing the Informed Consent Form
  • Subjects in the age between 18 and 55 years old with normal weight as determined by a body mass index (BMI) between 18 and 30 kg/m\^2, with a body weight of at least 50 kg for male subjects or 45 kg for female subjects
  • Subject has clinical laboratory test results within the reference ranges of the testing laboratory or outside the reference range of the laboratory but considered as not clinically significant by the Investigator
  • Subjects has blood pressure (BP) and pulse within normal range in a supine position after 5 minutes rest
  • Subject's electrocardiogram (ECG) is considered normal or abnormal but clinically non significant
  • Female subjects of childbearing potential must agree to use a highly effective method of birth control during the study and for a period of 6 months after dosing of IMP

Exclusion criteria

Exclusion Criteria:

  • Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study: Subject has any acute or chronic illness which, in the opinion of the Investigator, may place the subject at risk because of participation in the study. Subject has any clinically relevant abnormal findings in physical examination, laboratory tests, vital signs, or ECG, which, in the opinion of the Investigator, may place the subject at risk because of participation in the study.
  • Tests positive for Human Immunodeficiency Virus (HIV)-1 or-2 antibodies, Hepatitis B Virus (HBV) surface antigen, or Hepatitis C Virus (HCV) antibody at Screening
  • Any of the following hematological function tests at the Screening Visit: Hemoglobin \<111g/L (for women) or \<113g/L (for men)
  • Absolute neutrophil count \<1.5x10\^9/L (\<1000/mm\^3); Platelets \<150x10\^9/L
  • Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 6 months following the final dose of the IMP

For subjects enrolled in the cohorts where the skin biopsies will be performed (Cohort 7 onward), the following exclusion criteria will also apply:

  • Subject has a known hypersensitivity to dressings, local anesthetics, suture material, or relevant local/oral antibiotic therapy
  • Subject has or had a history of a known inflammatory dermatological condition including eczema, atopic dermatitis, candidiasis, psoriasis, recurrent or persistent fungal infection, or bacterial infections
  • Subject uses steroid or nonsteroidal anti-inflammatory drug (NSAID)-containing skin creams on a regular basis
  • Subject has used NSAID or NSAID-containing medications within 7 days of randomization
  • Subject has used skin emollients within 7 days of randomization on the area of the skin from buttocks
  • Subject has tattoos, nevi, or other skin abnormalities such as keloids (or history of keloids, folliculitis, or acne vulgaris) that may, in the opinion of the Investigator, interfere with study assessments.
  • Subject has been participating in recreational sun-bathing, or use of sun-bed, on the area of the skin from buttocks within 7 days of Screening
  • Subject has active neoplastic disease or history of neoplastic disease within 5 years of the Screening Visit
  • Subject has a history of moderate to severe allergic reaction to medication(s) including biologics (for subjects in Cohort 11 only).
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    UCB7858 (intravenous)

    Various single doses, administered to various cohorts.

    Drug: UCB7858

  • Placebo comparator
    Placebo (intravenous)

    Single dose placebo comparator for each cohort of iv administration.

    Drug: Placebo

  • Experimental
    UCB7858 (subcutaneous)

    Various single doses, administered to various cohorts.

    Drug: UCB7858

  • Placebo comparator
    Placebo (subcutaneous)

    Single dose placebo comparator for each cohort of sc administration.

    Drug: Placebo

Interventions

  • DrugUCB7858
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

07

Study locations

1 site
  • Up0029 001
    London, United Kingdom
08

References and documents

Individual participant data

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2016 to primary completion in Jan 2018, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2016
First posted
Aug 26, 2016
StartActual
Jul 11, 2016
Primary completionActual
Jan 31, 2018
CompletionActual
Jan 31, 2018
Last update
Aug 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02879877
Responsible party
Sponsor
First posted
Aug 26, 2016
Start date
Jul 11, 2016
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018
Last update
Aug 21, 2019

Study contacts

UCB Cares
study director · UCB (+1 844 599 2273)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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