Healthy VolunteersPhase 1NCT02879877
A First-In-Human Study With a Single Ascending Dose of UCB7858 in Healthy Volunteers
A Phase 1 study testing UCB7858 in people with Healthy Volunteers, run by UCB Biopharma S.P.R.L. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- UCB7858
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jul 2016to 31 Jan 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 15Show fewer
- 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).
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 Evaluating the Safety/Tolerability, Pharmacokinetics, Effect on Transglutaminase 2 Expression, and Occupancy of Single Ascending Intravenous and Subcutaneous Doses of UCB7858 in Healthy Subjects
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.
- Conditions
- Healthy Volunteers
- Being tested
- UCB7858, Placebo
- Keywords
- First in human, subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB7858Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| UCB7858 (intravenous) | Experimental | Various single doses, administered to various cohorts. Receives: Drug: UCB7858 |
| Placebo (intravenous) | Placebo comparator | Single dose placebo comparator for each cohort of iv administration. Receives: Drug: Placebo |
| UCB7858 (subcutaneous) | Experimental | Various single doses, administered to various cohorts. Receives: Drug: UCB7858 |
| Placebo (subcutaneous) | Placebo comparator | Single dose placebo comparator for each cohort of sc administration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events following administration of UCB7858
Measured: Cohort 1-10: Day 1 up to Day 72 Cohort 11: Day 1 up to Day 120
Secondary outcomes (12)
Maximum plasma concentration (Cmax)
Measured: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Time to reach Cmax (tmax)
Measured: 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)]
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Cohort 1-10: Predose (Day 1) up to Day 72 Cohort 11: Predose (Day 1) up to Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start11 Jul 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 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, UCB (+1 844 599 2273)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879877
- Sponsor's protocol ID
- UP0029
- Other IDs
- 2016-001129-15, 2016
- Status last verified
- Aug 2019
- First submitted
- 29 Jul 2016
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. 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 Evaluating the Safety/Tolerability, Pharmacokinetics, Effect on Transglutaminase 2 Expression, and Occupancy of Single Ascending Intravenous and Subcutaneous Doses of UCB7858 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02879877
- Acronym / sponsor ID
- UP0029
- Conditions
- Healthy Volunteers
- Keywords
- First in human, subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UCB7858 (intravenous) | Experimental | Drug: UCB7858Various single doses, administered to various cohorts. |
| Placebo (intravenous) | Placebo comparator | Drug: PlaceboSingle dose placebo comparator for each cohort of iv administration. |
| UCB7858 (subcutaneous) | Experimental | Drug: UCB7858Various single doses, administered to various cohorts. |
| Placebo (subcutaneous) | Placebo comparator | Drug: PlaceboSingle dose placebo comparator for each cohort of sc administration. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| UCB7858 | Drug | UCB7858 (intravenous), UCB7858 (subcutaneous) |
| Placebo | Drug | Placebo (intravenous), Placebo (subcutaneous) |
Primary outcome
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
12 secondary outcomes
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
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 21 Aug 2019.
- Individual participant dataSharing planned: 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.
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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
UCB (+1 844 599 2273)
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 UCB7858 in people with Healthy Volunteers, run by UCB Biopharma S.P.R.L. at 1 site in United Kingdom.
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 15 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 21 Aug 2019. 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 United Kingdom. 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?
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). 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 21 Aug 2019.