Healthy SubjectsPhase 1NCT03928262
Pharmacokinetic Study of Benralizumab in Healthy Chinese Subjects
A Phase 1 study testing Benralizumab in people with Healthy Subjects, run by AstraZeneca at 1 site in Hong Kong.
Trial summary
This is a Phase 1, randomized, single-blind study in healthy Chinese subjects at single dose administration of benralizumab: Treatment 1, Treatment 2 and Treatment 3. The study design allows an assessment of 3 doses with safety monitoring and PK sampling to evaluate the safety, tolerability and PK profile of… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Apr 2019to 12 Aug 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be willing and able to give written informed consent by signing an IRB/IEC approved Informed Consent Form (ICF) and follow the restrictions and procedures outlined for the study.
- Healthy adult males or females as determined by medical history, physical examination, and laboratory tests. Subjects age between 18 to 45 years old (inclusive) at the time of signing informed consent. Subject is a Han Chinese who were born in China (including Hong Kong) with Han Chinese parents and grandparents who were born in China (including Hong Kong)
- Have a body mass index (BMI) between 19 and 24 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.
- Medically healthy subjects with clinically insignificant screening results (e.g., laboratory profiles, medical histories, electrocardiograms [ECGs], physical examination). Haemoglobin must be greater than the lower limit of normal. A 12-lead ECG with QTc >340 msec and <450 msec.
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test prior to administration of the IP and use an effective form of birth control (confirmed by the Investigator or designee). Highly effective forms of birth control include: true sexual abstinence, a vasectomised sexual partner, Implanon, female sterilization by tubal occlusion, any effective IUD Intrauterine device/IUS Ievonorgestrel Intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch ™ or Nuvaring™. WOCBP must agree to use an effective method of birth control, as defined above, from enrolment, throughout the study duration and within 16 weeks (5 half-lives or longer) after the dosing and have negative serum or urine pregnancy test result on Visit 1 and Visit 2.
- Women of non-childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range.
- Male subjects should be willing to use condoms, in association with another method of contraception, from the day of the first dosing until 16 weeks (5 half-lives or longer) after the dosing.
Who cannot join
- Any subject with a history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorder that is capable of altering the metabolism or elimination of drugs or that constitutes a risk factor when taking the study medication.
- Any subject with a documented history of disorders of the immune system at any time.
- A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with or has failed to respond to standard of care therapy.
- Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1.
- Any subject with a clinically significant relevant deviation from normal in physical examination, electrocardiography, or clinical laboratory tests, as determined by the Principal Investigator.
- Any clinical significant findings off Chest x-rays or CT image. If a chest X-ray or CT has not been performed within 6 months prior to screening visit, a chest X-ray must be performed before the IP administration.
Show all 24Show fewer
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > the upper limit of normal (ULN).
- Positive result on screening for serum hepatitis B surface antigen, or hepatitis C antibody. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
- Any subject with any condition resulting in an increased eosinophil count at screening.
- Any condition requiring the regular use of any medication.
- Any subject requiring a prescription medication, other than contraceptives. Subjects taking nonprescription medications must be willing and able to refrain from their use during the inpatient period of the study.
- Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, systemic corticosteroid for condition other than short course for nasal polyps, or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent is obtained, and during the study period.
- Receipt of any marketed or investigational biologic (monoclonal or polyclonal antibody) within 4 months or 5 half-lives prior to the date informed consent, is obtained, whichever is longer, and during the study period. E.g. Previous receipt of mepolizumab, reslizumab, dupilumab, or benralizumab.
- Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
- Receipt of live attenuated vaccines 30 days prior to the date of informed consent.
- Any subject with known sensitivity to any constituent of benralizumab or any other IL-5 receptor antagonist. History of anaphylaxis to any biologic therapy.
- Any subject who has participated in any other study of an IP within either 30 days or 5 half-lives (if known) prior to Visit 1, whichever is longer.
- Current evidence of drug abuse or history of drug abuse within 1 year of randomization, and/or positive results of drug screen and alcohol test at screening and at Day -1.
- Subjects who have an average weekly alcohol intake that exceeds 21 units per week or subjects unwilling to stop alcohol consumption for the duration of the study (1 unit=12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
- Smoker of more than 5 cigarettes/day or equivalent use of nicotine products during the previous 3 months from the day of screening.
- Currently pregnant, breastfeeding or lactating women.
- Any subject who plans to undergo elective surgery within 4 weeks before Visit 3 (Day 1) through the end of the study (Day 85).
- Any subject who has donated blood or in any other way had a loss of blood volume greater than 400 mL within 30 days before beginning the study IP administration.
- Any subject who is unwilling to reside in the clinic during the study period or is unwilling to cooperate fully with the Principal Investigator or designee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Single-blind Study to Assess the Safety, Tolerability, and Pharmacokinetics of Benralizumab Administered as Single Subcutaneous Dose in Healthy Chinese Subjects
This is a Phase 1, randomized, single-blind study in healthy Chinese subjects at single dose administration of benralizumab: Treatment 1, Treatment 2 and Treatment 3. The study design allows an assessment of 3 doses with safety monitoring and PK sampling to evaluate the safety, tolerability and PK profile of benralizumab.
Read the detailed description
This study will be conducted at 1 study center in Hong Kong. Approximately 36 healthy Chinese male and female subjects, aged 18 to 45 inclusive, will be randomized in a 1:1:1 ratio to receive a single SC administration of benralizumab: Treatment 1, Treatment 2 and Treatment 3 (12 subjects per group). Each subject will participate in only 1 treatment group. Approximately 8-12 evaluable subjects in each group that met specific non-compartmental analysis (NCA) criteria are required to ensure eligible AUC0-∞ calculation. The total length of the study for each subject is up to 117 days (28 days of screening and 85+/- 4 days of further study visits).
- Conditions
- Healthy Subjects
- Being tested
- Benralizumab
- Keywords
- Pharmacokinetics, Safety, Tolerability, Benralizumab, Healthy Chinese subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabBiological
Treatment 1: Benralizumab single dose, Treatment 2: Benralizumab single dose and Treatment 3: Benralizumab single dose subcutaneously administration on 36 healthy Chinese male and female subjects in 1:1:1 ratio.
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab - Subcutaneous administration of Dose 1 | Experimental | Benralizumab single dose administration subcutaneously Receives: Biological: Benralizumab |
| Benralizumab - Subcutaneous administration of Dose 2 | Experimental | Benralizumab single dose administration subcutaneously Receives: Biological: Benralizumab |
| Benralizumab - Subcutaneous administration of Dose 3 | Experimental | Benralizumab single dose administration subcutaneously Receives: Biological: Benralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Adverse events (AEs) and serious adverse events (SAEs)
The number and percentage of subjects with treatment-emergent AE/SAE/AE by severity/drug-related AE/drug-related SAE/death in each dose level group and overall. AE/SAE will be displayed by MedDRA SOC and/or PT.
Measured: Day (-1) to Day 85
Safety as determined by abnormality in haematology
Measurement of red blood cell count, white blood cell count, haemoglobin and platelets
Measured: Day (-1) to Day 85
Safety as determined by abnormality in clinical chemistry
Measurement of kidney function (e.g.urea ,creatinine, Uric acid), liver function(ALP, ALT, AST, albumin, total bilirubin), lipid profile(total cholesterol, triglycerides), potassium.
Measured: Day (-1) to Day 85
Safety as determined by abnormality in urinalysis
Measurement of glucose, ketones, leukocytes, blood and protein
Measured: Day (-1) to Day 85
Safety as determined by evaluation of blood pressure in mmHg
Measurement of blood pressure (systolic and diastolic in mmHg)
Measured: Day (-1) to Day 85
Safety as determined by evaluation of Pulse rate in beats per minute
Measurement of Pulse rate in beats per minute
Measured: Day (-1) to Day 85
Safety as determined by evaluation of body temperature in degree Celsius
Measurement of body temperature in degree Celsius
Measured: Day (-1) to Day 85
Safety as determined by analysis of 12-lead ECG variables: heart rate (beats per minute)
The ECG variables will be summarized by absolute value at each visit by treatment group, together with the corresponding changes from baseline.
Measured: Day (-1) to Day 85
Safety as determined by analysis of 12-lead ECG variables: PR, QRS, QT and QTcF (milliseconds)
The ECG variables will be summarized by absolute value at each visit by treatment group, together with the corresponding changes from baseline.
Measured: Day (-1) to Day 85
Secondary outcomes (9)
Maximum observed concentration (Cmax)
To assess the Pharmacokinetic profile of Subcutaneously administration of benralizumab in healthy Chinese subjects.
Measured: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85
Time to maximum observed concentration (tmax)
To assess the Pharmacokinetic profile of subcutaneously administration of benralizumab in healthy Chinese subjects.
Measured: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85.
Area under the concentration-time curve from 0 to the last measurable time point (AUC0-t)
To assess the Pharmacokinetic profile of subcutaneously administration benralizumab in healthy Chinese subjects.
Measured: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85.
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
To assess the Pharmacokinetic profile of subcutaneously administration benralizumab in healthy Chinese subjects.
Measured: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85.
Apparent clearance (CL/F)
To assess the Pharmacokinetic profile of subcutaneously administration benralizumab in healthy Chinese subjects.
Measured: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85.
Apparent volume of distribution at terminal phase (Vz/F)
To assess the Pharmacokinetic profile of subcutaneously administration benralizumab in healthy Chinese subjects.
Measured: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85.
Time for concentration to decrease by 50% (concentration half-life) (t1/2)
To assess the Pharmacokinetic profile of subcutaneously administration benralizumab in healthy Chinese subjects.
Measured: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85.
Anti-drug antibody (ADA) as determined by evaluation of ADA positive percentage and ADA negative percentage
To assess the immunogenicity of benralizumab.
Measured: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 29, Day 57 and Day 85.
All ADA positive samples will be tested for neutralizing antibodies (nAb). nAb as determined by evaluation of nAb positive percentage
To assess the immunogenicity of benralizumab.
Measured: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 29, Day 57 and Day 85.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start2 Apr 2019
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Model description
- 36 healthy Chinese male and female subjects randomized in a 1:1:1 ratio to receive a single SC administration of benralizumab, Treatment 1, Treatment 2 and Treatment 3 (12 subjects per group). Each subject will participate in only 1 treatment group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tsang Tommy Cheung, MBBS, Principal investigator, HKU Phase 1 Clinical Trials Centre, 2/F, Block K, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928262
- Sponsor's protocol ID
- D3250C00034
- Status last verified
- Aug 2019
- First submitted
- 28 Jan 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Single-blind Study to Assess the Safety, Tolerability, and Pharmacokinetics of Benralizumab Administered as Single Subcutaneous Dose in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT03928262
- Acronym / sponsor ID
- D3250C00034
- Conditions
- Healthy Subjects
- Keywords
- Pharmacokinetics, Safety, Tolerability, Benralizumab, Healthy Chinese subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 26 Apr 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.
This is a Phase 1, randomized, single-blind study in healthy Chinese subjects at single dose administration of benralizumab: Treatment 1, Treatment 2 and Treatment 3. The study design allows an assessment of 3 doses with safety monitoring and PK sampling to evaluate the safety, tolerability and PK profile of benralizumab.
Detailed description
This study will be conducted at 1 study center in Hong Kong. Approximately 36 healthy Chinese male and female subjects, aged 18 to 45 inclusive, will be randomized in a 1:1:1 ratio to receive a single SC administration of benralizumab: Treatment 1, Treatment 2 and Treatment 3 (12 subjects per group). Each subject will participate in only 1 treatment group. Approximately 8-12 evaluable subjects in each group that met specific non-compartmental analysis (NCA) criteria are required to ensure eligible AUC0-∞ calculation. The total length of the study for each subject is up to 117 days (28 days of screening and 85+/- 4 days of further study visits).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 36 healthy Chinese male and female subjects randomized in a 1:1:1 ratio to receive a single SC administration of benralizumab, Treatment 1, Treatment 2 and Treatment 3 (12 subjects per group). Each subject will participate in only 1 treatment group.
| Arm | Type | Receives |
|---|---|---|
| Benralizumab - Subcutaneous administration of Dose 1 | Experimental | Biological: BenralizumabBenralizumab single dose administration subcutaneously |
| Benralizumab - Subcutaneous administration of Dose 2 | Experimental | Biological: BenralizumabBenralizumab single dose administration subcutaneously |
| Benralizumab - Subcutaneous administration of Dose 3 | Experimental | Biological: BenralizumabBenralizumab single dose administration subcutaneously |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects must be willing and able to give written informed consent by signing an IRB/IEC approved Informed Consent Form (ICF) and follow the restrictions and procedures outlined for the study.
- Healthy adult males or females as determined by medical history, physical examination, and laboratory tests. Subjects age between 18 to 45 years old (inclusive) at the time of signing informed consent. Subject is a Han Chinese who were born in China (including Hong Kong) with Han Chinese parents and grandparents who were born in China (including Hong Kong)
- Have a body mass index (BMI) between 19 and 24 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.
- Medically healthy subjects with clinically insignificant screening results (e.g., laboratory profiles, medical histories, electrocardiograms [ECGs], physical examination). Haemoglobin must be greater than the lower limit of normal. A 12-lead ECG with QTc >340 msec and <450 msec.
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test prior to administration of the IP and use an effective form of birth control (confirmed by the Investigator or designee). Highly effective forms of birth control include: true sexual abstinence, a vasectomised sexual partner, Implanon, female sterilization by tubal occlusion, any effective IUD Intrauterine device/IUS Ievonorgestrel Intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch ™ or Nuvaring™. WOCBP must agree to use an effective method of birth control, as defined above, from enrolment, throughout the study duration and within 16 weeks (5 half-lives or longer) after the dosing and have negative serum or urine pregnancy test result on Visit 1 and Visit 2.
Key exclusion criteria (24 listed)
- Any subject with a history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorder that is capable of altering the metabolism or elimination of drugs or that constitutes a risk factor when taking the study medication.
- Any subject with a documented history of disorders of the immune system at any time.
- A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with or has failed to respond to standard of care therapy.
- Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1.
- Any subject with a clinically significant relevant deviation from normal in physical examination, electrocardiography, or clinical laboratory tests, as determined by the Principal Investigator.
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 |
|---|---|---|
| BenralizumabTreatment 1: Benralizumab single dose, Treatment 2: Benralizumab single dose and Treatment 3: Benralizumab single dose subcutaneously administration on 36 healthy Chinese male and female subjects in 1:1:1 ratio. | Biological | Benralizumab - Subcutaneous administration of Dose 1, Benralizumab - Subcutaneous administration of Dose 2, Benralizumab - Subcutaneous administration of Dose 3 |
Primary outcome
Number of subjects with Adverse events (AEs) and serious adverse events (SAEs)
Time frame: Day (-1) to Day 85
The number and percentage of subjects with treatment-emergent AE/SAE/AE by severity/drug-related AE/drug-related SAE/death in each dose level group and overall. AE/SAE will be displayed by MedDRA SOC and/or PT.
Safety as determined by abnormality in haematology
Time frame: Day (-1) to Day 85
Measurement of red blood cell count, white blood cell count, haemoglobin and platelets
Safety as determined by abnormality in clinical chemistry
Time frame: Day (-1) to Day 85
Measurement of kidney function (e.g.urea ,creatinine, Uric acid), liver function(ALP, ALT, AST, albumin, total bilirubin), lipid profile(total cholesterol, triglycerides), potassium.
Safety as determined by abnormality in urinalysis
Time frame: Day (-1) to Day 85
Measurement of glucose, ketones, leukocytes, blood and protein
Safety as determined by evaluation of blood pressure in mmHg
Time frame: Day (-1) to Day 85
Measurement of blood pressure (systolic and diastolic in mmHg)
Safety as determined by evaluation of Pulse rate in beats per minute
Time frame: Day (-1) to Day 85
Measurement of Pulse rate in beats per minute
Safety as determined by evaluation of body temperature in degree Celsius
Time frame: Day (-1) to Day 85
Measurement of body temperature in degree Celsius
Safety as determined by analysis of 12-lead ECG variables: heart rate (beats per minute)
Time frame: Day (-1) to Day 85
The ECG variables will be summarized by absolute value at each visit by treatment group, together with the corresponding changes from baseline.
Safety as determined by analysis of 12-lead ECG variables: PR, QRS, QT and QTcF (milliseconds)
Time frame: Day (-1) to Day 85
The ECG variables will be summarized by absolute value at each visit by treatment group, together with the corresponding changes from baseline.
9 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85
Time to maximum observed concentration (tmax)
Time frame: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85.
Area under the concentration-time curve from 0 to the last measurable time point (AUC0-t)
Time frame: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85.
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
Time frame: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85.
Apparent clearance (CL/F)
Time frame: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85.
Apparent volume of distribution at terminal phase (Vz/F)
Time frame: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85.
Time for concentration to decrease by 50% (concentration half-life) (t1/2)
Time frame: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 2, Day 4, Day 5, Day 6, Day 8, Day 15, Day 29, Day 43, Day 57 and Day 85.
Anti-drug antibody (ADA) as determined by evaluation of ADA positive percentage and ADA negative percentage
Time frame: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 29, Day 57 and Day 85.
All ADA positive samples will be tested for neutralizing antibodies (nAb). nAb as determined by evaluation of nAb positive percentage
Time frame: Blood samples will be collected from Day 1 (1 hour prior to administration of IP) and on Day 29, Day 57 and 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 30 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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.
Tsang Tommy Cheung, MBBS principal investigator
HKU Phase 1 Clinical Trials Centre, 2/F, Block K, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong
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 Benralizumab in people with Healthy Subjects, run by AstraZeneca at 1 site in Hong Kong.
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 24 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 30 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 Hong Kong. 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. 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?
Number of subjects with Adverse events (AEs) and serious adverse events (SAEs) (time frame: Day (-1) to Day 85). The study lists 9 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 30 Aug 2019.