HealthyPhase 1NCT02220153
A First-In-Human Study With a Single Dose UCB7665 in Healthy Volunteers
A Phase 1 study testing UCB7665 Intravenous 1, UCB7665 Intravenous 2 and UCB7665 Intravenous 3 in people with Healthy, run by UCB Celltech at 1 site in United Kingdom.
Trial summary
This study is designed to evaluate the safety and tolerability of single ascending doses of UCB7665 administered by intravenous or subcutaneous infusion 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
- What is being tested?
- UCB7665 Intravenous 1, UCB7665 Intravenous 2 and UCB7665 Intravenous 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Sep 2015
- 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
- Healthy male and female volunteers of non-childbearing potential who gave their consent to the written informed consent form
- Healthy volunteers in the age between 18 and 64 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
- Subjects has blood pressure (BP) and pulse within normal range in a supine position after 5 minutes rest
- Subject has clinical laboratory test results within the reference ranges of the testing laboratory or test results that are outside the specified ranges and that are deemed as clinically non-significant
- Subject's electrocardiogram (ECG) is considered "normal" or "abnormal" but clinically non-significant
Who cannot join
- Subject has had significant blood loss, or has donated blood in excess of 400 mL of blood or blood products within 90 days before Day -2, or plans to donate blood during the clinical study
- Subject has a total Immuneglobulin G <7 g/L or >16 g/L at the Screening Visit
- Subject has absolute neutrophil count <1.5x10^9/L and/or lymphocyte count <1.0x10^9/L
- Subject has known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive
- Subject tests positive to Human Immunodeficiency Virus (HIV) 1/2 antibodies
- Subject has a past medical history or family history of primary immunodeficiency
Show all 21Show fewer
- Subject is splenectomized
- Subject has a positive TIGRA (T cell interferon γ release assay) at the Screening Visit. If TIGRA is not available, purified protein derivative (PPD) skin test can be substituted and/or chest x-ray performed within 6 months before the Screening Visit showing no evidence of latent/active Tuberculosis (TB)
- Subject has past (in the last 12 months ) or present substance abuse/dependence or concurrent medical conditions that in the opinion of the investigator could confound clinical study interpretation or affect the subject's ability to fully participate in the clinical study
- Subject has a known hypersensitivity to any components of the Investigational Medicinal Product (IMP)
- Subject has an active infection or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks before the first dose of IMP
- Subject has 12-lead electrocardiogram (ECG) with changes considered to be clinically significant upon medical review
- Subject has renal impairment
- Subject has hepatic impairment
- Subject has corrected serum calcium of >11.5 mg/dL (>2.9 mmol/L) or <8.0 mg/dL (<2.0 mmol/L) at the Screening Visit
- Subject has active neoplastic disease or history of neoplastic disease within 5 years of entry in the clinical study
- Subject has any other acute or chronic illness which, in the opinion of the investigator or study physician, could pose a threat or harm to the subjects
- Subject has received a vaccination within 6 weeks before the Screening Visit or intends to have a vaccination before Day 43 of the Safety Follow-up Period
- Subject has received any IMP or experimental procedure within 90 days before the first dose of IMP
- Subject requires a treatment other than Paracetamol during the clinical study
- Subject is a vulnerable subject (e.g. subject kept in detention) (Declaration of Helsinki, 1996)
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 Intravenous and Subcutaneous Doses of UCB7665 in Healthy Subjects
This study is designed to evaluate the safety and tolerability of single ascending doses of UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.
- Conditions
- Healthy
- Being tested
- UCB7665 Intravenous 1, UCB7665 Intravenous 2, UCB7665 Intravenous 3, UCB7665 Intravenous 4, UCB7665 Intravenous 5
- Keywords
- Monoclonal antibody, subjects, First in human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB7665 Intravenous 1Biological
- Active substance: UCB7665
- Pharmaceutical form: solution
- Concentration: 140 mg/mL
- Route of Administration: intravenous infusion
UCB7665 Intravenous 2Biological
- Active substance: UCB7665
- Pharmaceutical form: solution
- Concentration: 140 mg/mL
- Route of Administration: intravenous infusion
UCB7665 Intravenous 3Biological
- Active substance: UCB7665
- Pharmaceutical form: solution
- Concentration: 140 mg/mL
- Route of Administration: intravenous infusion
UCB7665 Intravenous 4Biological
- Active substance: UCB7665
- Pharmaceutical form: solution
- Concentration: 140 mg/mL
- Route of Administration: intravenous infusion
UCB7665 Intravenous 5Biological
- Active substance: UCB7665
- Pharmaceutical form: solution
- Concentration: 140 mg/mL
- Route of Administration: intravenous infusion
UCB7665 Subcutaneous 1Biological
- Active substance: UCB7665
- Pharmaceutical form: solution
- Concentration: 140 mg/mL
- Route of Administration: subcutaneous infusion
UCB7665 Subcutaneous 2Biological
- Active substance: UCB7665
- Pharmaceutical form: solution
- Concentration: 140 mg/mL
- Route of Administration: subcutaneous infusion
Intravenous PlaceboBiological
- Active substance: Placebo
- Pharmaceutical form: solution
- Concentration: 0.9 % saline
- Route of Administration: intravenous infusion
Subcutaneous PlaceboBiological
- Active substance: Placebo
- Pharmaceutical form: solution
- Concentration: 0.9 % saline
- Route of Administration: subcutaneous infusion
| Study group | Role | What they receive |
|---|---|---|
| UCB7665 Intravenous 1 | Experimental | Single dose calculated based on body weight for 60 minutes intravenous infusion. Receives: Biological: UCB7665 Intravenous 1 |
| UCB7665 Intravenous 2 | Experimental | Single dose calculated based on body weight for 60 minutes intravenous infusion. Receives: Biological: UCB7665 Intravenous 2 |
| UCB7665 Intravenous 3 | Experimental | Single dose calculated based on body weight for 60 minutes intravenous infusion. Receives: Biological: UCB7665 Intravenous 3 |
| UCB7665 Intravenous 4 | Experimental | Single dose calculated based on body weight for 60 minutes intravenous infusion. Receives: Biological: UCB7665 Intravenous 4 |
| UCB7665 Intravenous 5 | Experimental | Single dose calculated based on body weight for 60 minutes intravenous infusion. Receives: Biological: UCB7665 Intravenous 5 |
| UCB7665 Subcutaneous 1 | Experimental | Single dose calculated based on body weight for 60 minutes subcutaneous infusion. Receives: Biological: UCB7665 Subcutaneous 1 |
| UCB7665 Subcutaneous 2 | Experimental | Single dose calculated based on body weight for 60 minutes subcutaneous infusion. Receives: Biological: UCB7665 Subcutaneous 2 |
| Intravenous Placebo | Placebo comparator | Single dose placebo comparator for each active arm of intravenous infusion. Receives: Biological: Intravenous Placebo |
| Subcutaneous Placebo | Placebo comparator | Single dose placebo comparator for each active arm of subcutaneous infusion. Receives: Biological: Subcutaneous Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events during the study
Measured: Day -1 up to Day 85
Secondary outcomes (9)
Maximum plasma concentration (Cmax)
The value of the maximum plasma concentration will be directly obtained from the observed plasma concentration versus time curves. Pharmacokinetic samples will be taken predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
Measured: Predose (Day 1) up to Day 85
Area under the curve from 0 to infinity (AUC)
AUC will be calculated using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
Measured: Predose (Day 1) up to Day 85
Area under the curve from time 0 to time t, the time of last quantifiable concentration [AUC(0-t)]
AUC(0-t) will be calculated using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
Measured: Predose (Day 1) up to Day 85
Time to reach Cmax (Tmax)
Tmax will be directly obtained from the observed plasma concentration versus time curves, using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
Measured: Predose (Day 1) up to Day 85
Total Immunoglobulin G (IgG ) concentrations
Total Immunoglobulin G will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
Measured: Predose (Day 1) up to Day 85
Immunoglobulin G1 subclass concentrations
Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
Measured: Predose (Day 1) up to Day 85
Immunoglobulin G2 subclass concentrations
Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
Measured: Predose (Day 1) up to Day 85
Immunoglobulin G3 subclass concentrations
Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
Measured: Predose (Day 1) up to Day 85
Immunoglobulin G4 subclass concentrations
Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
Measured: Predose (Day 1) up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Celltech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220153
- Sponsor's protocol ID
- UP0018
- Other IDs
- 2013-005469-38
- Status last verified
- Oct 2015
- First submitted
- 18 Aug 2014
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kiessling P, Lledo-Garcia R, Watanabe S, Langdon G, Tran D, Bari M, Christodoulou L, Jones E, Price G, Smith B, Brennan F, White I, Jolles S. The FcRn inhibitor rozanolixizumab reduces human serum IgG concentration: A randomized phase 1 study. Sci Transl Med. 2017 Nov 1;9(414):eaan1208. doi: 10.1126/scitranslmed.aan1208.
PubMed 29093180
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. 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 Intravenous and Subcutaneous Doses of UCB7665 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02220153
- Acronym / sponsor ID
- UP0018
- Conditions
- Healthy
- Keywords
- Monoclonal antibody, subjects, First in human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- UCB CelltechIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Aug 2014 (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 UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| UCB7665 Intravenous 1 | Experimental | Biological: UCB7665 Intravenous 1Single dose calculated based on body weight for 60 minutes intravenous infusion. |
| UCB7665 Intravenous 2 | Experimental | Biological: UCB7665 Intravenous 2Single dose calculated based on body weight for 60 minutes intravenous infusion. |
| UCB7665 Intravenous 3 | Experimental | Biological: UCB7665 Intravenous 3Single dose calculated based on body weight for 60 minutes intravenous infusion. |
| UCB7665 Intravenous 4 | Experimental | Biological: UCB7665 Intravenous 4Single dose calculated based on body weight for 60 minutes intravenous infusion. |
| UCB7665 Intravenous 5 | Experimental | Biological: UCB7665 Intravenous 5Single dose calculated based on body weight for 60 minutes intravenous infusion. |
| UCB7665 Subcutaneous 1 | Experimental | Biological: UCB7665 Subcutaneous 1Single dose calculated based on body weight for 60 minutes subcutaneous infusion. |
| UCB7665 Subcutaneous 2 | Experimental | Biological: UCB7665 Subcutaneous 2Single dose calculated based on body weight for 60 minutes subcutaneous infusion. |
| Intravenous Placebo | Placebo comparator | Biological: Intravenous PlaceboSingle dose placebo comparator for each active arm of intravenous infusion. |
| Subcutaneous Placebo | Placebo comparator | Biological: Subcutaneous PlaceboSingle dose placebo comparator for each active arm of subcutaneous infusion. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female volunteers of non-childbearing potential who gave their consent to the written informed consent form
- Healthy volunteers in the age between 18 and 64 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
- Subjects has blood pressure (BP) and pulse within normal range in a supine position after 5 minutes rest
- Subject has clinical laboratory test results within the reference ranges of the testing laboratory or test results that are outside the specified ranges and that are deemed as clinically non-significant
- Subject's electrocardiogram (ECG) is considered "normal" or "abnormal" but clinically non-significant
Key exclusion criteria (21 listed)
- Subject has had significant blood loss, or has donated blood in excess of 400 mL of blood or blood products within 90 days before Day -2, or plans to donate blood during the clinical study
- Subject has a total Immuneglobulin G <7 g/L or >16 g/L at the Screening Visit
- Subject has absolute neutrophil count <1.5x10^9/L and/or lymphocyte count <1.0x10^9/L
- Subject has known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive
- Subject tests positive to Human Immunodeficiency Virus (HIV) 1/2 antibodies
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 |
|---|---|---|
| UCB7665 Intravenous 1* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: intravenous infusion | Biological | UCB7665 Intravenous 1 |
| UCB7665 Intravenous 2* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: intravenous infusion | Biological | UCB7665 Intravenous 2 |
| UCB7665 Intravenous 3* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: intravenous infusion | Biological | UCB7665 Intravenous 3 |
| UCB7665 Intravenous 4* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: intravenous infusion | Biological | UCB7665 Intravenous 4 |
| UCB7665 Intravenous 5* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: intravenous infusion | Biological | UCB7665 Intravenous 5 |
| UCB7665 Subcutaneous 1* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: subcutaneous infusion | Biological | UCB7665 Subcutaneous 1 |
| UCB7665 Subcutaneous 2* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: subcutaneous infusion | Biological | UCB7665 Subcutaneous 2 |
| Intravenous Placebo* Active substance: Placebo * Pharmaceutical form: solution * Concentration: 0.9 % saline * Route of Administration: intravenous infusion | Biological | Intravenous Placebo |
| Subcutaneous Placebo* Active substance: Placebo * Pharmaceutical form: solution * Concentration: 0.9 % saline * Route of Administration: subcutaneous infusion | Biological | Subcutaneous Placebo |
Primary outcome
Incidence of adverse events during the study
Time frame: Day -1 up to Day 85
9 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Predose (Day 1) up to Day 85
Area under the curve from 0 to infinity (AUC)
Time frame: Predose (Day 1) up to Day 85
Area under the curve from time 0 to time t, the time of last quantifiable concentration [AUC(0-t)]
Time frame: Predose (Day 1) up to Day 85
Time to reach Cmax (Tmax)
Time frame: Predose (Day 1) up to Day 85
Total Immunoglobulin G (IgG ) concentrations
Time frame: Predose (Day 1) up to Day 85
Immunoglobulin G1 subclass concentrations
Time frame: Predose (Day 1) up to Day 85
Immunoglobulin G2 subclass concentrations
Time frame: Predose (Day 1) up to Day 85
Immunoglobulin G3 subclass concentrations
Time frame: Predose (Day 1) up to Day 85
Immunoglobulin G4 subclass concentrations
Time frame: Predose (Day 1) up to Day 85
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 5 Oct 2015.
- Derived from this study: PubMed 29093180Kiessling P, Lledo-Garcia R, Watanabe S, Langdon G, Tran D, Bari M, Christodoulou L, Jones E, Price G, Smith B, Brennan F, White I, Jolles S. The FcRn inhibitor rozanolixizumab reduces human serum IgG concentration: A randomized phase 1 study. Sci Transl Med. 2017 Nov 1;9(414):eaan1208. doi: 10.1126/scitranslmed.aan1208.
Related trials for Healthy
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Adaptive Optics Retinal Imaging
Eye Diseases, Healthy Volunteers
Recruiting
Neural and Psychological Mechanisms of Pain Perception
Pain, Normal Physiology
RecruitingObservational study
Studies of Dermatologic Diseases Biospecimen Acquisition Protocol
Dermatologic Conditions, Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
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 Clinical Trial Call Center study director
UCB Pharma
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 UCB7665 Intravenous 1, UCB7665 Intravenous 2 and UCB7665 Intravenous 3 in people with Healthy, run by UCB Celltech 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 5 inclusion and 21 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 5 Oct 2015. 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 during the study (time frame: Day -1 up to Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02220153, which also lists 1 linked publication.
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 5 Oct 2015; AzTrials last refreshed its copy on 4 Nov 2026.