Healthy SubjectsPhase 1DIRECTION-CKNCT04362410
Tezepelumab Phase 1 PK Study in Healthy Chinese Subjects
A Phase 1 study testing Experimental: Tezepelumab in people with Healthy Subjects, run by AstraZeneca at 1 site in China.
Trial summary
This is a Phase 1, Single Centre, Double-blind, Randomized, Placebo-controlled Parallel-group Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Tezepelumab after Single-Dose Subcutaneous Administration in Healthy Chinese Subjects. 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?
- Experimental: Tezepelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2020to 9 Oct 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female healthy Chinese subjects
- Age 18 to 45
- Body weight ≥ 40 kg
- Body mass index (BMI) between 19-24 kg/m2
Who cannot join
- History or evidence of a clinically significant disorder
- History of cancer
- Smokers of > 5 cigarettes/day
- Receipt of any marketed or investigational biologic within 4 months or 5 half-lives/non-biologic agent within 30 days or 5 half-lives prior to randomization
- History of chronic alcohol or drug abuse
- Hepatitis B, C or HIV
- Pregnant or breastfeeding
- History of anaphylaxis following any biologic therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single Centre, Double-blind, Randomized, Placebo-controlled Parallel-group Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Tezepelumab After Single-Dose Subcutaneous Administration in Healthy Chinese Subjects (DIRECTION-CK)
This is a Phase 1, Single Centre, Double-blind, Randomized, Placebo-controlled Parallel-group Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Tezepelumab after Single-Dose Subcutaneous Administration in Healthy Chinese Subjects.
Read the detailed description
This is a Phase 1, single centre, randomized, double-blind, placebo-controlled, single dose, parallel group study in healthy Chinese male or female subjects. 48 healthy subjects will be randomly assigned to one of the three treatment cohorts (i.e. 1:1:1 to Low dose, Medium dose and High dose) to receive a single dose of tezepelumab or placebo in a 3:1 ratio. Each subject will only participate in one cohort. Dose level is unblinded and treatment (tezepelumab or placebo) will be double-blinded within each treatment cohort. Following a screening period of a maximum of 28 days, subjects will stay at the study facility for two nights starting from the day before dosing (Day -1) to Day 2. Subjects will receive a single dose of tezepelumab or placebo subcutaneously on Day 1 and safety monitoring and serial collection of blood samples for PK evaluation will be followed throughout the study period. The follow up period after the dosing will be 112 days.
- Conditions
- Healthy Subjects
- Being tested
- Experimental: Tezepelumab, Placebo
- Keywords
- Pharmacokinetics, Safety, Tolerability, Immunogenicity, Tezepelumab, Healthy Chinese Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: TezepelumabBiological
Also called Tezepelumab
Tezepelumab single dose subcutaneously injection.
PlaceboOther
Placebo single dose subcutaneously injection.
| Study group | Role | What they receive |
|---|---|---|
| Tezepelumab: Low dose | Experimental | Tezepelumab: Tezepelumab single dose subcutaneously injection. Receives: Biological: Experimental: Tezepelumab |
| Tezepelumab: Medium dose | Experimental | Tezepelumab: Tezepelumab single dose subcutaneously injection. Receives: Biological: Experimental: Tezepelumab |
| Tezepelumab: High dose | Experimental | Tezepelumab: Tezepelumab single dose subcutaneously injection. Receives: Biological: Experimental: Tezepelumab |
| Placebo | Placebo comparator | Placebo single dose subcutaneously injection. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf (Area under the serum concentration versus time curve from time zero to Infinity)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Measured: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
AUC0-t (Area under the serum concentration versus time curve from time zero to the last quantifiable concentration)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Measured: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
Cmax (Maximum serum concentration)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Measured: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
tmax (time to Cmax)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Measured: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
t1/2 (terminal serum half-life)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Measured: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
CL/F (apparent serum clearance)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Measured: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
Vz/F (apparent volume of distribution)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Measured: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
Secondary outcomes (1)
Immunogenicity anti-drug antibodies
Incidence of anti-drug antibodies following single dose of tezepelumab
Measured: Blood samples will be collected on Day 1 (3 hour prior to administration of IP) and on Day 29, Day 113.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start18 May 2020
- Primary completion9 Oct 2020
- Study completion9 Oct 2020
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
- 48 healthy subjects will be randomly assigned to one of the three treatment cohorts (i.e. 1:1:1 to Low dose, Medium dose and High dose). 16 subjects will participate in each treatment cohort. Within each cohort, subjects will be randomized in a 3:1 ratio to receive a single dose of tezepelumab or placebo. Each subject will only participate in one cohort.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Jinfang Hu, Master, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362410
- Sponsor's protocol ID
- D5180C00020
- Acronym
- DIRECTION-CK
- Status last verified
- Nov 2020
- First submitted
- 23 Apr 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Centre, Double-blind, Randomized, Placebo-controlled Parallel-group Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Tezepelumab After Single-Dose Subcutaneous Administration in Healthy Chinese Subjects (DIRECTION-CK)
- ClinicalTrials.gov ID
- NCT04362410
- Acronym / sponsor ID
- DIRECTION-CK / D5180C00020
- Conditions
- Healthy Subjects
- Keywords
- Pharmacokinetics, Safety, Tolerability, Immunogenicity, Tezepelumab, Healthy Chinese Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- 18 May 2020 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 24 Apr 2020 (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, Single Centre, Double-blind, Randomized, Placebo-controlled Parallel-group Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Tezepelumab after Single-Dose Subcutaneous Administration in Healthy Chinese Subjects.
Detailed description
This is a Phase 1, single centre, randomized, double-blind, placebo-controlled, single dose, parallel group study in healthy Chinese male or female subjects. 48 healthy subjects will be randomly assigned to one of the three treatment cohorts (i.e. 1:1:1 to Low dose, Medium dose and High dose) to receive a single dose of tezepelumab or placebo in a 3:1 ratio. Each subject will only participate in one cohort. Dose level is unblinded and treatment (tezepelumab or placebo) will be double-blinded within each treatment cohort. Following a screening period of a maximum of 28 days, subjects will stay at the study facility for two nights starting from the day before dosing (Day -1) to Day 2. Subjects will receive a single dose of tezepelumab or placebo subcutaneously on Day 1 and safety monitoring and serial collection of blood samples for PK evaluation will be followed throughout the study period. The follow up period after the dosing will be 112 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- 48 healthy subjects will be randomly assigned to one of the three treatment cohorts (i.e. 1:1:1 to Low dose, Medium dose and High dose). 16 subjects will participate in each treatment cohort. Within each cohort, subjects will be randomized in a 3:1 ratio to receive a single dose of tezepelumab or placebo. Each subject will only participate in one cohort.
| Arm | Type | Receives |
|---|---|---|
| Tezepelumab: Low dose | Experimental | Biological: Experimental: TezepelumabTezepelumab: Tezepelumab single dose subcutaneously injection. |
| Tezepelumab: Medium dose | Experimental | Biological: Experimental: TezepelumabTezepelumab: Tezepelumab single dose subcutaneously injection. |
| Tezepelumab: High dose | Experimental | Biological: Experimental: TezepelumabTezepelumab: Tezepelumab single dose subcutaneously injection. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo single dose subcutaneously injection. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female healthy Chinese subjects
- Age 18 to 45
- Body weight ≥ 40 kg
- Body mass index (BMI) between 19-24 kg/m2
Key exclusion criteria (8 listed)
- History or evidence of a clinically significant disorder
- History of cancer
- Smokers of > 5 cigarettes/day
- Receipt of any marketed or investigational biologic within 4 months or 5 half-lives/non-biologic agent within 30 days or 5 half-lives prior to randomization
- History of chronic alcohol or drug abuse
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 |
|---|---|---|
| Experimental: TezepelumabAlso: TezepelumabTezepelumab single dose subcutaneously injection. | Biological | Tezepelumab: High dose, Tezepelumab: Low dose, Tezepelumab: Medium dose |
| PlaceboPlacebo single dose subcutaneously injection. | Other | Placebo |
Primary outcome
AUC0-inf (Area under the serum concentration versus time curve from time zero to Infinity)
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
AUC0-t (Area under the serum concentration versus time curve from time zero to the last quantifiable concentration)
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Cmax (Maximum serum concentration)
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
tmax (time to Cmax)
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
t1/2 (terminal serum half-life)
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
CL/F (apparent serum clearance)
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Vz/F (apparent volume of distribution)
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
1 secondary outcome
Immunogenicity anti-drug antibodies
Time frame: Blood samples will be collected on Day 1 (3 hour prior to administration of IP) and on Day 29, Day 113.
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 17 Nov 2020.
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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.
Jinfang Hu, Master principal investigator
The First Affiliated Hospital of Nanchang University
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 Experimental: Tezepelumab in people with Healthy Subjects, run by AstraZeneca at 1 site in China.
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 4 inclusion and 8 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 17 Nov 2020. 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 China. 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?
AUC0-inf (Area under the serum concentration versus time curve from time zero to Infinity) (time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.). The study lists 7 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 17 Nov 2020.