Evaluate PK ProfilePhase 1PK/ADANCT04840849
Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
A Phase 1 study testing nirsevimab in people with Evaluate PK Profile, run by AstraZeneca at 1 site in China.
Trial summary
The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of Nirsevimab in Healthy Chinese Adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluate PK Profile
- What is being tested?
- nirsevimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2021to 18 Nov 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 to 45 years
- Weight ≥ 45 kg and ≤ 110 kg and Body Mass Index of 19 to 26 kg/m2
- Healthy Chinese subjects (both male and female)
- Normotensive
- Normal electrocardiogram (ECG) within 28 days prior to Day 1
Who cannot join
- Acute illness at study entry (pre-dose on Day 1)
- Fever ≥99.5°F (37.5°C) on day of dosing
- Any drug therapy within 14 days prior to Day 1 (except contraceptives).
- Receipt of immunoglobulin or blood products within 6 months prior to study entry.
- Receipt of any investigational drug therapy within 120 days prior to investigational product dosing or planned to receive any investigational drug therapy within 150 days after investigational product dosing.
- Previous receipt of any marketed or investigational mAb.
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- Previous vaccination against RSV.
- History of immunodeficiency or receipt of immunosuppressive medications during the prior year.
- History of asthma.
- History of autoimmune disorder.
- Evidence of any systemic disease on physical examination.
- Evidence of infection with hepatitis A, B, or C virus, syphilis, or human immunodeficiency virus.
- Any clinically significant abnormal laboratory assessments at screening.
- Pregnant or nursing mother.
- Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of Nirsevimab in Healthy Chinese Adults.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the PK, safety and tolerability, and ADA of nirsevimab when administered as a single fixed IM dosage to healthy Chinese adult subjects. Enrolment is planned at a single study center in China. Approximately 24 subjects will be randomly assigned in a 3:1 ratio to receive nirsevimab (n = 18) or placebo (n = 6). All subjects will be followed for approximately 150 days after dosing to assess safety, PK, and ADA response.
- Conditions
- Evaluate PK Profile
- Being tested
- nirsevimab, Placebo
- Keywords
- PK, safety, tolerability, Nirsevimab, healthy Chinese Adults, Respiratory Syncytial Viral (RSV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nirsevimabBiological
Also called MEDI8897
Drug: injection, a single fixed IM dose on day 1 only.
PlaceboOther
Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only.
| Study group | Role | What they receive |
|---|---|---|
| Nirsevimab | Experimental | Nirsevimab single dose IM injection Receives: Biological: nirsevimab |
| Placebo | Placebo comparator | Placebo single dose IM injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Concentrations of Nirsevimab
Serum samples were collected at indicated timepoints to determine the serum concentration of nirsevimab.
Measured: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose.
Maximum Observed Serum Concentration (Cmax) for Nirsevimab
Cmax for nirsevimab was directly calculated from the individual concentration-time curve.
Measured: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax) for Nirsevimab
Tmax for nirsevimab was directly calculated from the individual concentration-time curve.
Measured: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab
Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab was calculated by linear up/log down trapezoidal summation.
Measured: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
Secondary outcomes (1)
Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab
ADA positive was defined as any participant with a positive ADA result available at any time, including baseline and all post-baseline measurements; otherwise ADA negative.
Measured: Baseline (Day 1) and Days 31, 91 and 151
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start22 Jun 2021
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Evaluate PK ProfileStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS (Shanghai) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840849
- Sponsor's protocol ID
- D5290C00007
- Acronym
- PK/ADA
- Status last verified
- Dec 2022
- First submitted
- 8 Apr 2021
- Last updated
- 2 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
- ClinicalTrials.gov ID
- NCT04840849
- Acronym / sponsor ID
- PK/ADA / D5290C00007
- Conditions
- Evaluate PK Profile
- Keywords
- PK, safety, tolerability, Nirsevimab, healthy Chinese Adults, Respiratory Syncytial Viral (RSV)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS (Shanghai) Co., Ltd.
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Posted 2 Nov 2023
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 this study is to evaluate the Pharmacokinetics, Safety, Tolerability of Nirsevimab in Healthy Chinese Adults.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the PK, safety and tolerability, and ADA of nirsevimab when administered as a single fixed IM dosage to healthy Chinese adult subjects. Enrolment is planned at a single study center in China. Approximately 24 subjects will be randomly assigned in a 3:1 ratio to receive nirsevimab (n = 18) or placebo (n = 6). All subjects will be followed for approximately 150 days after dosing to assess safety, PK, and ADA response.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nirsevimab | Experimental | Biological: nirsevimabNirsevimab single dose IM injection |
| Placebo | Placebo comparator | Other: PlaceboPlacebo single dose IM injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 45 years
- Weight ≥ 45 kg and ≤ 110 kg and Body Mass Index of 19 to 26 kg/m2
- Healthy Chinese subjects (both male and female)
- Normotensive
- Normal electrocardiogram (ECG) within 28 days prior to Day 1
Key exclusion criteria (15 listed)
- Acute illness at study entry (pre-dose on Day 1)
- Fever ≥99.5°F (37.5°C) on day of dosing
- Any drug therapy within 14 days prior to Day 1 (except contraceptives).
- Receipt of immunoglobulin or blood products within 6 months prior to study entry.
- Receipt of any investigational drug therapy within 120 days prior to investigational product dosing or planned to receive any investigational drug therapy within 150 days after investigational product dosing.
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 |
|---|---|---|
| nirsevimabAlso: MEDI8897Drug: injection, a single fixed IM dose on day 1 only. | Biological | Nirsevimab |
| PlaceboPlacebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only. | Other | Placebo |
Primary outcome
Serum Concentrations of Nirsevimab
Time frame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose.
Serum samples were collected at indicated timepoints to determine the serum concentration of nirsevimab.
Maximum Observed Serum Concentration (Cmax) for Nirsevimab
Time frame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
Cmax for nirsevimab was directly calculated from the individual concentration-time curve.
Time to Reach Maximum Observed Serum Concentration (Tmax) for Nirsevimab
Time frame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
Tmax for nirsevimab was directly calculated from the individual concentration-time curve.
Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab
Time frame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab was calculated by linear up/log down trapezoidal summation.
1 secondary outcome
Number of Participants With Positive Anti-Drug Antibody (ADA) of Nirsevimab
Time frame: Baseline (Day 1) and Days 31, 91 and 151
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CSP\_RedactedLink provided by the sponsor.
- SAP\_RedactedLink provided by the sponsor.
- CSR\_Synopsis\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 nirsevimab in people with Evaluate PK Profile, 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 5 inclusion and 15 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 2 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Concentrations of Nirsevimab (time frame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose.). The study lists 4 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 2 Nov 2023.