Healthy Japanese VolunteersPhase 1NCT03605082
A Study to Test the Safety and Tolerability and Pharmacokinetics of Single Doses of UCB0107 in Healthy Japanese Subjects
A Phase 1 study testing UCB0107 in people with Healthy Japanese Volunteers, run by UCB Biopharma S.P.R.L. at 1 site in United Kingdom.
Trial summary
The purpose of the study is to evaluate the safety and tolerability and serum Pharmacokinetics (PK) of single doses of UCB0107 administered in healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Japanese Volunteers
- What is being tested?
- UCB0107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jul 2018to 11 Mar 2019
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is male or female, >=20 and <=75 years of age
- Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan)
- Subject has a body mass index (BMI) >=18.0 and <=30.0 kg/m^2, with a body weight of at least 50 kilogram (kg) for males and 45 kg for females, and maximum 100 kg
- Subject is in good physical and mental health, in particular is not affected by any neurological disorder, in the opinion of the Investigator, as determined on the basis of medical history and a general clinical examination at Screening
- Subject has clinical laboratory test results within the reference ranges of the laboratory
- Subject has Blood pressure and pulse rate within normal range in supine position after 5 minutes rest
- Subject's electrocardiogram (ECG) is considered "normal," or "abnormal" but clinically nonsignificant (as interpreted by the Investigator)
Who cannot join
- Subject has any clinically relevant abnormal findings in physical examination, laboratory tests, vital signs, or electrocardiogram, which, in the opinion of the Investigator, may place the subject at risk because of participation in the study
- Subject has a history of recurrent headaches, including migraine
- Subject has a history of alcohol and/or drug abuse up to 6 months before Screening
- Subject smokes on average >5 cigarettes/day (or equivalent) during the last 3 months and is not able to stop smoking during the In-Clinic Period
- Subject has any clinically relevant brain magnetic resonance imaging (MRI) abnormality at Screening
- Subject has >upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%)
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- Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 2 years
- Subject has a positive serology test for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at Screening
- Subject has a known hypersensitivity to any components of the investigational medicinal product (IMP), comparative drugs, any biologic or small molecule, or concomitant medication as stated in this protocol
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Investigator-blind, Subject Blind, Randomized, Placebo-controlled Study to Evaluate Safety and Tolerability and Pharmacokinetics of Single Doses of UCB0107 in Healthy Japanese Subjects
The purpose of the study is to evaluate the safety and tolerability and serum Pharmacokinetics (PK) of single doses of UCB0107 administered in healthy Japanese subjects.
- Conditions
- Healthy Japanese Volunteers
- Being tested
- UCB0107, Placebo
- Keywords
- UCB0107, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB0107Drug
- Pharmaceutical form: solution for infusion
- Route of administration: intravenous use
PlaceboOther
- Pharmaceutical form: solution for infusion
- Route of administration: intravenous use
| Study group | Role | What they receive |
|---|---|---|
| UCB0107 | Experimental | Subjects will be randomized to receive a predefined dosage of UCB0107 in order to maintain the blinding. Receives: Drug: UCB0107 |
| Placebo | Placebo comparator | Subjects will be randomized and receive a placebo in order to maintain the blinding. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of treatment-emergent adverse events during the study from first dose of UCB0107 to safety follow-up/withdraw
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Measured: From first dose of UCB0107 to safety follow-up/withdraw on day 140 +/-4 days
Maximum observed serum concentration of UCB0107 during the study
Pharmacokinetic variable:
Cmax: maximum observed serum concentration
Measured: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Area under the concentration-time curve from time 0 to infinity of UCB0107 during the study
Pharmacokinetic variable:
AUC: area under the concentration-time curve from time 0 to infinity
Measured: The blood samples for serum Pharmacokinetics will be taken from predose to Day 140
Area under the concentration-time curve from time 0 to time t of UCB0107 during the study
Pharmacokinetic variable:
AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration
Measured: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Terminal half-life of UCB0107 during the study
Pharmacokinetic variable:
t1/2: terminal half-life
Measured: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Volume of distribution of UCB0107 during the study
Pharmacokinetic variable:
Vz: volume of distribution
Measured: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
The clearance of UCB0107 during the study
Pharmacokinetic variable:
CL: clearance
Measured: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
The time to maximum observed serum concentration of UCB0107 during the study
Pharmacokinetic variable:
tmax: time to maximum observed serum concentration
Measured: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start25 Jul 2018
- Primary completion11 Mar 2019
- Study completion11 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Japanese 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
- 24 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, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605082
- Sponsor's protocol ID
- UP0065
- Other IDs
- 2018-000475-32, 2018
- Status last verified
- Mar 2019
- First submitted
- 29 Jun 2018
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Investigator-blind, Subject Blind, Randomized, Placebo-controlled Study to Evaluate Safety and Tolerability and Pharmacokinetics of Single Doses of UCB0107 in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT03605082
- Acronym / sponsor ID
- UP0065
- Conditions
- Healthy Japanese Volunteers
- Keywords
- UCB0107, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 30 Jul 2018 (actual)
- 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.
The purpose of the study is to evaluate the safety and tolerability and serum Pharmacokinetics (PK) of single doses of UCB0107 administered in healthy Japanese subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCB0107 | Experimental | Drug: UCB0107Subjects will be randomized to receive a predefined dosage of UCB0107 in order to maintain the blinding. |
| Placebo | Placebo comparator | Other: PlaceboSubjects will be randomized and receive a placebo in order to maintain the blinding. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is male or female, >=20 and <=75 years of age
- Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan)
- Subject has a body mass index (BMI) >=18.0 and <=30.0 kg/m^2, with a body weight of at least 50 kilogram (kg) for males and 45 kg for females, and maximum 100 kg
- Subject is in good physical and mental health, in particular is not affected by any neurological disorder, in the opinion of the Investigator, as determined on the basis of medical history and a general clinical examination at Screening
- Subject has clinical laboratory test results within the reference ranges of the laboratory
Key exclusion criteria (10 listed)
- Subject has any clinically relevant abnormal findings in physical examination, laboratory tests, vital signs, or electrocardiogram, which, in the opinion of the Investigator, may place the subject at risk because of participation in the study
- Subject has a history of recurrent headaches, including migraine
- Subject has a history of alcohol and/or drug abuse up to 6 months before Screening
- Subject smokes on average >5 cigarettes/day (or equivalent) during the last 3 months and is not able to stop smoking during the In-Clinic Period
- Subject has any clinically relevant brain magnetic resonance imaging (MRI) abnormality at Screening
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 |
|---|---|---|
| UCB0107* Pharmaceutical form: solution for infusion * Route of administration: intravenous use | Drug | UCB0107 |
| Placebo* Pharmaceutical form: solution for infusion * Route of administration: intravenous use | Other | Placebo |
Primary outcome
The incidence of treatment-emergent adverse events during the study from first dose of UCB0107 to safety follow-up/withdraw
Time frame: From first dose of UCB0107 to safety follow-up/withdraw on day 140 +/-4 days
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Maximum observed serum concentration of UCB0107 during the study
Time frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Pharmacokinetic variable: Cmax: maximum observed serum concentration
Area under the concentration-time curve from time 0 to infinity of UCB0107 during the study
Time frame: The blood samples for serum Pharmacokinetics will be taken from predose to Day 140
Pharmacokinetic variable: AUC: area under the concentration-time curve from time 0 to infinity
Area under the concentration-time curve from time 0 to time t of UCB0107 during the study
Time frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Pharmacokinetic variable: AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration
Terminal half-life of UCB0107 during the study
Time frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Pharmacokinetic variable: t1/2: terminal half-life
Volume of distribution of UCB0107 during the study
Time frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Pharmacokinetic variable: Vz: volume of distribution
The clearance of UCB0107 during the study
Time frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Pharmacokinetic variable: CL: clearance
The time to maximum observed serum concentration of UCB0107 during the study
Time frame: The blood sampling time points for serum Pharmacokinetics will be as follows: predose (<=60 minutes before dosing); end of infusion, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose; and on Day 7, 14, 28, 42, 56, 84 and 140
Pharmacokinetic variable: tmax: time to maximum observed serum concentration
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 14 Mar 2019.
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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
001 844 599 2273 (UCB)
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 UCB0107 in people with Healthy Japanese 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 7 inclusion and 10 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 14 Mar 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?
The incidence of treatment-emergent adverse events during the study from first dose of UCB0107 to safety follow-up/withdraw (time frame: From first dose of UCB0107 to safety follow-up/withdraw on day 140 +/-4 days). The study lists 8 primary outcomes in all. 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 14 Mar 2019.