Healthy VolunteersPhase 1NCT02873767
A First-In-Human Study With a Single Dose UCB4019 in Healthy Volunteers
A Phase 1 study testing PR1 and PL1 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 single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PR1 and PL1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Feb 2017
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good physical and mental health
- At least 18 and less than 65 years of age
- Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their last dose of study drug
Who cannot join
- Total Immunoglobulin G <7 g/L or >16 g/L at the Screening Visit
- Absolute neutrophil count <1.5x10^9/L and/or lymphocyte count <1.0x10^9/L
- Known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive
- Positive test to Human Immunodeficiency Virus (HIV) 1/2 antibodies
- Past medical history or family history of primary immunodeficiency
- Evidence of latent/active Tuberculosis (TB)
Show all 13Show fewer
- Active infection or a serious infection within 6 weeks before the first dose of IMP
- Renal impairment
- Hepatic impairment
- Vaccination within 6 weeks before the Screening Visit or intent to have a vaccination before Day 43 of the Safety Follow-up Period
- Subject is splenectomized
- received any IMP or experimental procedure within 90 days before the first dose of IMP
- received UCB7665 in a clinical study
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, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of UCB4019 in Healthy Subjects
This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.
- Conditions
- Healthy Volunteers
- Being tested
- PR1, PL1
- Keywords
- First in human, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PR1Drug
- Active substance: UCB4019
- Route of Administration: subcutaneously
PL1Other
- Active substance: Placebo
- Concentration: 0.9 % saline
- Route of Administration: subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single dose placebo comparator for each active arm Receives: Other: PL1 |
| UCB4019 Dose 1 | Experimental | Dose 1 calculated based on body weight Receives: Drug: PR1 |
| UCB4019 Dose 2 | Experimental | Dose 2 calculated based on body weight Receives: Drug: PR1 |
| UCB4019 Dose 3 | Experimental | Dose 3 calculated based on body weight Receives: Drug: PR1 |
| UCB4019 Dose 4 | Experimental | Dose 4 calculated based on body weight Receives: Drug: PR1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events during the study
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Measured: Day 1 up to Day 57
Secondary outcomes (6)
Maximum plasma concentration (Cmax)
Measured: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19
Area under the curve from 0 to time t, the time of last quantifiable concentration [(AUC0-t)]
Measured: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19
Time to reach Cmax (Tmax)
Measured: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19
Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7
Measured: Predose (Day 1), Day 7
Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10
Measured: Predose (Day 1), Day 10
Change from Baseline in total Immunoglobulin G (IgG) concentration at day 13
Measured: Predose (Day 1), Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2017
- Study completionFeb 2017
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 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 (+1 887 822 9493)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873767
- Sponsor's protocol ID
- UP0028
- Other IDs
- 2016-000772-26, 2016
- Status last verified
- Feb 2017
- First submitted
- 16 Aug 2016
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. 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, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of UCB4019 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02873767
- Acronym / sponsor ID
- UP0028
- Conditions
- Healthy Volunteers
- Keywords
- First in human, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 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 single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PL1Single dose placebo comparator for each active arm |
| UCB4019 Dose 1 | Experimental | Drug: PR1Dose 1 calculated based on body weight |
| UCB4019 Dose 2 | Experimental | Drug: PR1Dose 2 calculated based on body weight |
| UCB4019 Dose 3 | Experimental | Drug: PR1Dose 3 calculated based on body weight |
| UCB4019 Dose 4 | Experimental | Drug: PR1Dose 4 calculated based on body weight |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good physical and mental health
- At least 18 and less than 65 years of age
- Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their last dose of study drug
Key exclusion criteria (13 listed)
- Total Immunoglobulin G <7 g/L or >16 g/L at the Screening Visit
- Absolute neutrophil count <1.5x10^9/L and/or lymphocyte count <1.0x10^9/L
- Known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive
- Positive test to Human Immunodeficiency Virus (HIV) 1/2 antibodies
- Past medical history or family history of primary immunodeficiency
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 |
|---|---|---|
| PR1* Active substance: UCB4019 * Route of Administration: subcutaneously | Drug | UCB4019 Dose 1, UCB4019 Dose 2, UCB4019 Dose 3, UCB4019 Dose 4 |
| PL1* Active substance: Placebo * Concentration: 0.9 % saline * Route of Administration: subcutaneously | Other | Placebo |
Primary outcome
Incidence of treatment emergent adverse events during the study
Time frame: Day 1 up to Day 57
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
6 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19
Area under the curve from 0 to time t, the time of last quantifiable concentration [(AUC0-t)]
Time frame: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19
Time to reach Cmax (Tmax)
Time frame: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19
Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7
Time frame: Predose (Day 1), Day 7
Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10
Time frame: Predose (Day 1), Day 10
Change from Baseline in total Immunoglobulin G (IgG) concentration at day 13
Time frame: Predose (Day 1), Day 13
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 9 Feb 2017.
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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 (+1 887 822 9493)
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 PR1 and PL1 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 3 inclusion and 13 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 9 Feb 2017. 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 treatment emergent adverse events during the study (time frame: Day 1 up to Day 57). 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 9 Feb 2017; AzTrials last refreshed its copy on 28 Oct 2026.