Trial reportClinical pharmacokinetics2026
Pharmacokinetic Comparability Assessment of Tixagevimab and Cilgavimab Developed for COVID-19 Prevention and Treatment Using Standard Exposure Metrics and Partial Area Under the Curve.
Trial report in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05166421 (Phase 1, Randomized, Open Label, Three-arm, Single Dose, Parallel Group Study to Compare AZD7442), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 1, Randomized, Open Label, Three-arm, Single Dose, Parallel Group Study to Compare AZD7442 (AZD8895 + AZD1061) Pharmacokinetic Exposure Following Intramuscular Administration as a Co-formulation Versus Administration From Two Separate Vials of the Individual Monoclonal Antibodies in Adult Healthy Participants
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveAZD7442 is a combination of extended half-life monoclonal antibodies (mAbs; tixagevimab and cilgavimab), developed to neutralize SARS-CoV-2. This open-label Phase 1 study compared pharmacokinetics (PK) of three AZD7442 formulations in which component mAbs were (1) co-formulated versus separately formulated and (2) derived from clonal cell line or cell pool material when separately formulated.
methodsHealthy adults were randomized 1:1:1 to receive intramuscular (IM) AZD7442 300 mg (150 mg each of tixagevimab and cilgavimab) via one injection of co-formulated tixagevimab and cilgavimab from clonal cell line material (treatment A), or two sequential injections of tixagevimab and cilgavimab formulated separately either from clonal cell line (treatment B) or cell pool material (treatment C). Serial blood samples were collected up to 360 days post-dose to evaluate serum concentrations and anti-drug antibody responses. Standard exposure metrics (C
resultsIn total, 224 participants were randomized and dosed. Serum concentration-time profiles overlapped post dosing across treatments. Median time to reach peak concentration occurred within 2 weeks with mean terminal half-life 74-84 days. Pharmacokinetic comparability for tixagevimab, cilgavimab and AZD7442 was demonstrated between treatments, with geometric mean ratios (GMR) and 90% CI within 0.8000-1.2500 using traditional exposure metrics (C
conclusionsPharmacokinetic comparability of tixagevimab, cilgavimab and AZD7442 was demonstrated between the different treatments based on analyses using traditional bioequivalence metrics or pAUCs. Partial AUC could serve as an exposure metric when evaluating PK comparability for extended half-life mAbs. TRIAL REGISTRY: Clinical trials registration number: ClinicalTrials.gov NCT05166421.
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