Adults 5 to 11, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Observed Serum Concentration (Cmax) of TezepelumabPrimary· Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
Blood samples were collected to determine the Cmax of tezepelumab. The Pharmacokinetic (PK) parameters were estimated using non-compartmental analysis method.
Group
Value
95% CI
Tezepelumab
27.1
± 11.9
Time to Achieve Maximum Observed Serum Concentration (Tmax) of TezepelumabPrimary· Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
Blood samples were collected to determine the tmax of tezepelumab. The PK parameters were estimated using non-compartmental analysis method.
Group
Value
95% CI
Tezepelumab
3.47
1.92 – 9.96
Area Under the Concentration-Time Curve From Time Zero to The Last Measurable Concentration (AUC0-last) of TezepelumabPrimary· Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
Blood samples were collected to determine the AUC0-last of tezepelumab and calculated by linear up/log down trapezoidal summation. The PK parameters were estimated using non-compartmental analysis method.
Group
Value
95% CI
Tezepelumab
872
± 285
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of TezepelumabPrimary· Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
Blood samples were collected to determine the AUC0-inf of tezepelumab and calculated by linear up/log down trapezoidal summation and extrapolated to infinity by the addition of the last quantifiable concentration divided by the terminal rate constant. The PK parameters were estimated using non-compartmental analysis method.
Group
Value
95% CI
Tezepelumab
974
± 320
Terminal Phase Elimination Half-Life (t1/2) of TezepelumabPrimary· Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
Blood samples were collected to determine the t1/2 of tezepelumab and calculated as ln(2)/λZ, where λZ is the first-order rate constant associated with the terminal (log-linear) elimination phase. The PK parameters were estimated using non-compartmental analysis method.
Group
Value
95% CI
Tezepelumab
25.7
± 5.94
Apparent Clearance (CL/F) of TezepelumabPrimary· Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
Blood samples were collected to determine the CL/F of tezepelumab and estimated as dose divided by AUC0-inf. The PK parameters were estimated using non-compartmental analysis method.
Group
Value
95% CI
Tezepelumab
0.0802
± 0.0295
Apparent Steady-State Volume of Distribution (Vss/F) of TezepelumabPrimary· Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
Blood samples were collected to determine the Vss/F of tezepelumab and estimated as CL/F\*mean residence time (MRT), where MRT=Area under the moment curve of the analyte in the sampled matrix from zero (predose) extrapolated to infinite time/(AUC0-inf). The PK parameters were estimated using non-compartmental analysis method.
Group
Value
95% CI
Tezepelumab
3.08
± 1.32
Apparent Volume of Distribution (Vz/F) of TezepelumabPrimary· Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
Blood samples were collected to determine the Vz/F of tezepelumab and estimated as CL/F\*1/ λZ. The PK parameters were estimated using non-compartmental analysis method.
Group
Value
95% CI
Tezepelumab
2.98
± 1.26
Number of Participants With Anti-Drug Antibody (ADA) Response to TezepelumabSecondary· Predose and within ± 1 hour of postdose on Day 1; on Days 29 and 85
Blood samples were analyzed for the presence of ADAs for tezepelumab using validated assays. ADA prevalence was defined as ADA positive at baseline and/or post baseline. ADA incidence was defined as the percentage of treatment-emergent ADA positive participants in a population. Treatment induced ADA positive was defined as ADA negative at baseline and post-baseline ADA positive. Treatment-boosted ADA positive was defined as baseline positive ADA titre that was boosted to a 4-fold or higher level following study drug administration. Treatment-emergent ADA positive was defined as either treatmen
ADA prevalence
Group
Value
95% CI
Tezepelumab
3
Only baseline ADA positive
Group
Value
95% CI
Tezepelumab
2
Baseline and at least 1 post-baseline ADA positive
Group
Value
95% CI
Tezepelumab
1
Baseline ADA positive regardless of post-baseline
Group
Value
95% CI
Tezepelumab
3
Any post-baseline ADA positive
Group
Value
95% CI
Tezepelumab
1
Treatment-induced ADA positive
Group
Value
95% CI
Tezepelumab
0
Treatment-boosted ADA positive
Group
Value
95% CI
Tezepelumab
0
Treatment-emergent ADA positive
Group
Value
95% CI
Tezepelumab
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose administration (Day 1) up to study completion (End of Study/Day 85 visit) or withdrawal date.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate the pharmacokinetic (PK) profile of a single subcutaneous (SC) dose of tezepelumab in children aged ≥ 5 to 11 years with asthma.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07520162 — A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab
· Phase 3
· not yet recruiting
NCT07015996 — Efficacy of Tezepelumab in Peanut Oral Immunotherapy
· Phase 2
· not yet recruiting
NCT07363642 — Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab
· Phase 3
· recruiting
NCT07046117 — Effect of Tezepelumab on Barrier Function in Severe Asthmatic Patients With and Without Comorbid Chronic Rhinosinusitis
· NA
· not yet recruiting
NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t
· Phase 2
· recruiting
NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being
· NA
· recruiting
NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
· recruiting
NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ
· Phase 1
· recruiting
Other AstraZeneca trials
Trials by the same sponsor.
NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea
· not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential
· not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis
· NA
· not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec
· Phase 4
· not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 8 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04673630.