Healthy-volunteersPhase 1NCT03859219
A Study to Evaluate Safety and Tolerability of Single Ascending Doses of Rozanolixizumab Administered by Subcutaneous Infusion in Healthy Japanese, Chinese and Caucasian Study Participants
A Phase 1 study testing Rozanolixizumab in people with Healthy-volunteers, run by UCB Biopharma S.P.R.L. at 1 site in United Kingdom.
Trial summary
The purpose of the study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of rozanolixizumab in japanese, chinese and caucasian healthy-volunteer study participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy-volunteers
- What is being tested?
- Rozanolixizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Mar 2019to 28 Apr 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study participant must be 18 to 65 years of age, inclusive, at the time of signing the Informed Consent form (ICF)
- Study participants who are overtly healthy in the opinion of the investigator as determined by medical history and a general clinical examination, including physical examination, laboratory tests, and cardiac monitoring
- Study participant must be considered reliable and capable of adhering to the protocol, according to the judgment of the investigator, and is able to communicate satisfactorily with the investigator and comply with all clinical study requirements
- Japanese or Chinese study participant is of Japanese or Chinese descent, determined by verbal confirmation of familial heritage with all 4 grandparents of Japanese or Chinese descent
- Caucasian study participant is of Caucasian descent as evidenced in appearance and verbal confirmation of familial heritage with all 4 grandparents of Caucasian descent
- Study participant is of normal weight as determined by a body mass index (BMI) between 18 and 32 kg/m2, inclusive, with a body weight of at least 50 kg (male) or 45 kg (female) and no greater than 100 kg
Who cannot join
- Any medical (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could harm the study participant or would compromise the study participant's ability to participate in this study.
- History of known inflammatory bowel disease, active diverticular disease, or a history of confirmed duodenal, gastric, or esophageal ulceration in the previous 6 months
- Significant allergies to humanized monoclonal antibodies
- Known hypersensitivity to any components of the investigational medicinal product (IMP)
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
Show all 12Show fewer
- Study participant is splenectomized, or has a clinically relevant active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to study treatment
- Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
- Received a vaccination within 8 weeks prior to Day -1; or intends to have a vaccination during the course of the study. Prior/Concurrent clinical study experience
- Exposure to more than 3 new chemical entities within 12 months prior to dosing
- Previously participated in this clinical study or has previously been assigned to treatment in a clinical study of IMP under investigation in this clinical study
- Participated in another study of an IMP (or a medical device) within the previous 90 days or 5 half-lives prior to Day -1 (whichever is longer) or is currently participating in another study of an IMP (or a medical device)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study Comparing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of Rozanolixizumab in Japanese, Chinese and Caucasian Healthy-Volunteer Study Participants
The purpose of the study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of rozanolixizumab in japanese, chinese and caucasian healthy-volunteer study participants.
- Conditions
- Healthy-volunteers
- Being tested
- Rozanolixizumab, Placebo
- Keywords
- Rozanolixizumab, Caucasian healthy-volunteers, Japanese healthy-volunteers, Phase 1, UCB7665, Chinese healthy-volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RozanolixizumabDrug
- Pharmaceutical form: solution for injection
- Route of administration: subcutaneous infusion
PlaceboDrug
- Pharmaceutical form: solution for injection
- Route of administration: subcutaneous infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 of rozanolixizumab in Japanese subjects | Experimental | Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. Receives: Drug: Rozanolixizumab |
| Dose 2 of rozanolixizumab in Japanese subjects | Experimental | Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. Receives: Drug: Rozanolixizumab |
| Dose 3 of rozanolixizumab in Japanese subjects | Experimental | Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. Receives: Drug: Rozanolixizumab |
| Dose 1 of rozanolixizumab in Caucasian subjects | Experimental | Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. Receives: Drug: Rozanolixizumab |
| Dose 2 of rozanolixizumab in Caucasian subjects | Experimental | Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. Receives: Drug: Rozanolixizumab |
| Dose 3 of rozanolixizumab in Caucasian subjects | Experimental | Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. Receives: Drug: Rozanolixizumab |
| Dose 2 of rozanolixizumab in Chinese subjects | Experimental | Chinese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. Receives: Drug: Rozanolixizumab |
| Dose 3 of rozanolixizumab in Chinese subjects | Experimental | Chinese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. Receives: Drug: Rozanolixizumab |
| Placebo in Japanese subjects | Placebo comparator | Japanese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding. Receives: Drug: Placebo |
| Placebo in Chinese subjects | Placebo comparator | Chinese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding. Receives: Drug: Placebo |
| Placebo in Caucasian subjects | Placebo comparator | Caucasian subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Japanese study participants
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From Baseline until Safety Follow-up (up to Week 8)
Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Chinese study participants
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From Baseline until Safety Follow-up (up to Week 8)
Maximum observed plasma concentration (Cmax) of rozanolixizumab in healthy Japanese study participants
Maximum observed plasma concentration (Cmax)
Measured: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Maximum observed plasma concentration (Cmax) of rozanolixizumab in healthy Chinese study participants
Maximum observed plasma concentration (Cmax)
Measured: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Time to maximum observed plasma concentration (tmax) of rozanolixizumab in healthy Japanese study participants
Time of observed Cmax (tmax)
Measured: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Time to maximum observed plasma concentration (tmax) of rozanolixizumab in healthy Chinese study participants
Time of observed Cmax (tmax)
Measured: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of rozanolixizumab in healthy Japanese study participants
AUC(0-t): Area under the curve from time 0 to time t, the time of last quantifiable concentration
Measured: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of rozanolixizumab in healthy Chinese study participants
AUC(0-t): Area under the curve from time 0 to time t, the time of last quantifiable concentration
Measured: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Secondary outcomes (7)
Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Caucasian
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From Baseline until Safety Follow-up (up to Week 8)
AUC(0-t)/BW: Body weight normalized AUC(0-t) of rozanolixizumab
AUC(0-t)/BW: Body weight normalized AUC(0-t) of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants
Measured: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
AUC(0-t)/D: Dose normalized AUC(0-t)
AUC(0-t)/D: Dose normalized AUC(0-t) of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants
Measured: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
AUC(0-t)/D/BW: Dose and body weight normalized AUC(0-t)
AUC(0-t)/D/BW: Dose and body weight normalized AUC(0-t) of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants
Measured: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Cmax/BW: Body weight normalized Cmax of rozanolixizumab
Cmax/BW: Body weight normalized Cmax of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants
Measured: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Cmax/D: Dose normalized Cmax
Cmax/D: Dose normalized Cmax of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants
Measured: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Cmax/D/BW: Dose and body weight normalized Cmax
Cmax/D/BW: Dose and body weight normalized Cmax of rozanolixizumab in healthy Japanese, Chinese and Caucasian study participants
Measured: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start18 Mar 2019
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
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
- 65 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
- NCT03859219
- Sponsor's protocol ID
- UP0060
- Other IDs
- 2018-004485-34, 2018
- Status last verified
- Sep 2021
- First submitted
- 28 Feb 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study Comparing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of Rozanolixizumab in Japanese, Chinese and Caucasian Healthy-Volunteer Study Participants
- ClinicalTrials.gov ID
- NCT03859219
- Acronym / sponsor ID
- UP0060
- Conditions
- Healthy-volunteers
- Keywords
- Rozanolixizumab, Caucasian healthy-volunteers, Japanese healthy-volunteers, Phase 1, UCB7665, Chinese healthy-volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 1 Mar 2019 (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 assess safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of rozanolixizumab in japanese, chinese and caucasian healthy-volunteer study participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Dose 1 of rozanolixizumab in Japanese subjects | Experimental | Drug: RozanolixizumabJapanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
| Dose 2 of rozanolixizumab in Japanese subjects | Experimental | Drug: RozanolixizumabJapanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
| Dose 3 of rozanolixizumab in Japanese subjects | Experimental | Drug: RozanolixizumabJapanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
| Dose 1 of rozanolixizumab in Caucasian subjects | Experimental | Drug: RozanolixizumabCaucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
| Dose 2 of rozanolixizumab in Caucasian subjects | Experimental | Drug: RozanolixizumabCaucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
| Dose 3 of rozanolixizumab in Caucasian subjects | Experimental | Drug: RozanolixizumabCaucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
| Dose 2 of rozanolixizumab in Chinese subjects | Experimental | Drug: RozanolixizumabChinese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
| Dose 3 of rozanolixizumab in Chinese subjects | Experimental | Drug: RozanolixizumabChinese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding. |
| Placebo in Japanese subjects | Placebo comparator | Drug: PlaceboJapanese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding. |
| Placebo in Chinese subjects | Placebo comparator | Drug: PlaceboChinese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding. |
| Placebo in Caucasian subjects | Placebo comparator | Drug: PlaceboCaucasian subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Study participant must be 18 to 65 years of age, inclusive, at the time of signing the Informed Consent form (ICF)
- Study participants who are overtly healthy in the opinion of the investigator as determined by medical history and a general clinical examination, including physical examination, laboratory tests, and cardiac monitoring
- Study participant must be considered reliable and capable of adhering to the protocol, according to the judgment of the investigator, and is able to communicate satisfactorily with the investigator and comply with all clinical study requirements
- Japanese or Chinese study participant is of Japanese or Chinese descent, determined by verbal confirmation of familial heritage with all 4 grandparents of Japanese or Chinese descent
- Caucasian study participant is of Caucasian descent as evidenced in appearance and verbal confirmation of familial heritage with all 4 grandparents of Caucasian descent
Key exclusion criteria (12 listed)
- Any medical (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could harm the study participant or would compromise the study participant's ability to participate in this study.
- History of known inflammatory bowel disease, active diverticular disease, or a history of confirmed duodenal, gastric, or esophageal ulceration in the previous 6 months
- Significant allergies to humanized monoclonal antibodies
- Known hypersensitivity to any components of the investigational medicinal product (IMP)
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
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 |
|---|---|---|
| Rozanolixizumab* Pharmaceutical form: solution for injection * Route of administration: subcutaneous infusion | Drug | Dose 1 of rozanolixizumab in Caucasian subjects, Dose 1 of rozanolixizumab in Japanese subjects, Dose 2 of rozanolixizumab in Caucasian subjects, Dose 2 of rozanolixizumab in Chinese subjects, Dose 2 of rozanolixizumab in Japanese subjects, Dose 3 of rozanolixizumab in Caucasian subjects, Dose 3 of rozanolixizumab in Chinese subjects, Dose 3 of rozanolixizumab in Japanese subjects |
| Placebo* Pharmaceutical form: solution for injection * Route of administration: subcutaneous infusion | Drug | Placebo in Caucasian subjects, Placebo in Chinese subjects, Placebo in Japanese subjects |
Primary outcome
Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Japanese study participants
Time frame: From Baseline until Safety Follow-up (up to Week 8)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Chinese study participants
Time frame: From Baseline until Safety Follow-up (up to Week 8)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Maximum observed plasma concentration (Cmax) of rozanolixizumab in healthy Japanese study participants
Time frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Maximum observed plasma concentration (Cmax)
Maximum observed plasma concentration (Cmax) of rozanolixizumab in healthy Chinese study participants
Time frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Maximum observed plasma concentration (Cmax)
Time to maximum observed plasma concentration (tmax) of rozanolixizumab in healthy Japanese study participants
Time frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Time of observed Cmax (tmax)
Time to maximum observed plasma concentration (tmax) of rozanolixizumab in healthy Chinese study participants
Time frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Time of observed Cmax (tmax)
Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of rozanolixizumab in healthy Japanese study participants
Time frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
AUC(0-t): Area under the curve from time 0 to time t, the time of last quantifiable concentration
Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of rozanolixizumab in healthy Chinese study participants
Time frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
AUC(0-t): Area under the curve from time 0 to time t, the time of last quantifiable concentration
7 secondary outcomes
Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Caucasian
Time frame: From Baseline until Safety Follow-up (up to Week 8)
AUC(0-t)/BW: Body weight normalized AUC(0-t) of rozanolixizumab
Time frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
AUC(0-t)/D: Dose normalized AUC(0-t)
Time frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
AUC(0-t)/D/BW: Dose and body weight normalized AUC(0-t)
Time frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Cmax/BW: Body weight normalized Cmax of rozanolixizumab
Time frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Cmax/D: Dose normalized Cmax
Time frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Cmax/D/BW: Dose and body weight normalized Cmax
Time frame: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
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 16 Sep 2021.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial will not be shared.
Related trials for Healthy-volunteers
RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Imaging Techniques in MRI
Cardiac Risk Factors, Healthy
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 Rozanolixizumab 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 12 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 16 Sep 2021. 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?
Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Japanese study participants (time frame: From Baseline until Safety Follow-up (up to Week 8)). 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 16 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.