A Phase 1 interventional study of nirsevimab and Placebo in Evaluate PK Profile, sponsored by AstraZeneca. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by AstraZeneca · Phase 1, Interventional, and Other
The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of Nirsevimab in Healthy Chinese Adults.
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.
AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nirsevimab single dose IM injection
Biological: nirsevimab
Placebo single dose IM injection
Other: Placebo
Drug: injection, a single fixed IM dose on day 1 only.
Also known as: MEDI8897
Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only.
Serum Concentrations of Nirsevimab
Serum samples were collected at indicated timepoints to determine the serum concentration of nirsevimab.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: Pre-dose on Day 1 and on Days 2, 4, 6, 8, 15, 31, 91, 151 post-dose
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.
Time frame: Baseline (Day 1) and Days 31, 91 and 151
This was a Phase 1, placebo-controlled, study to evaluate pharmacokinetics (PK), safety, and tolerability of nirsevimab compared to placebo in healthy participants conducted at a single center in China.
| Milestone | Nirsevimab | Placebo |
|---|---|---|
| Started | 18 | 6 |
| Completed | 18 | 6 |
| Not completed | 0 | 0 |
Serum samples were collected at indicated timepoints to determine the serum concentration of nirsevimab.
| micrograms/milliliter (mcg/mL) | Nirsevimab |
|---|---|
| Pre-dose Day 1 | NA ± NA |
| Day 2 | 27.644 ± 5.819 |
| Day 4 | 41.794 ± 8.447 |
| Day 6 | 43.811 ± 8.291 |
| Day 8 | 46.050 ± 12.484 |
| Day 15 | 43.739 ± 7.236 |
| Day 31 | 40.300 ± 5.391 |
| Day 91 | 25.200 ± 3.694 |
| Day 151 | 17.597 ± 3.854 |
Cmax for nirsevimab was directly calculated from the individual concentration-time curve.
| mcg/mL | Nirsevimab |
|---|---|
| Maximum Observed Serum Concentration (Cmax) for Nirsevimab | 46.882 ± 21.7 |
Tmax for nirsevimab was directly calculated from the individual concentration-time curve.
| days | Nirsevimab |
|---|---|
| Time to Reach Maximum Observed Serum Concentration (Tmax) for Nirsevimab | 6.99 (4.91 to 29.90) |
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.
| mcg*day/mL | Nirsevimab |
|---|---|
| Area Under the Serum Concentration-Time Curve From Time 0 to 150 Days (AUC0-150) for Nirsevimab | 4210.56 ± 13.6 |
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.
| Participants | Nirsevimab |
|---|---|
| Baseline (Day 1) | 0 |
| Day 31 | 0 |
| Day 91 | 0 |
| Day 151 | 0 |
Collected over Treatment emergent adverse events were collected from first date of study treatment administration (Day 1) up to 151 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nirsevimab | 0/18 (0%) | 0/18 (0%) | 5/18 (27.8%) |
| Placebo | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Event | Nirsevimab | Placebo |
|---|---|---|
| Haemoglobin decreasedInvestigations | 1/18 | 1/6 |
| Blood bilirubin increasedInvestigations | 0/18 | 1/6 |
| Urobilinogen urine increasedInvestigations | 2/18 | 0/6 |
| Blood creatinine increasedInvestigations | 1/18 | 0/6 |
| Complement factor decreasedInvestigations | 1/18 | 0/6 |
| Platelet count decreasedInvestigations | 1/18 | 0/6 |
| DiarrhoeaGastrointestinal disorders | 1/18 | 0/6 |
As-treated population included all participants who were randomized into the study and received any amount of study treatment.
| Age, Continuous(years) | Nirsevimab | Placebo | Total |
|---|---|---|---|
| Mean | 29.2 ± 5.55 | 29.8 ± 4.71 | 29.3 ± 5.26 |
| Sex: Female, Male(Participants) | Nirsevimab | Placebo | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 15 | 2 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Nirsevimab | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 18 | 6 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Nirsevimab | Placebo | Total |
|---|---|---|---|
| Asian | 18 | 6 | 24 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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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