Trial reportBritish journal of clinical pharmacology2010
An open-label, single-dose bioavailability study of the pharmacokinetics of CAT-354 after subcutaneous and intravenous administration in healthy males.
Trial report in British journal of clinical pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00638989 (An Open-Label, Parallel-Group, Bioavailability Study to Assess the Pharmacokinetics of CAT-354 Following Subcutaneous and Intravenous Administration), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.
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.
An Open-Label, Parallel-Group, Bioavailability Study to Assess the Pharmacokinetics of CAT-354 Following Subcutaneous and Intravenous Administration
Who cites it
28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- Anti-interleukin-13 and anti-interleukin-4 agents versus placebo, anti-interleukin-5 or anti-immunoglobulin-E agents, for people with asthma.The Cochrane database of systematic reviews · 2021Pooled it
- A meta-analysis of anti-interleukin-13 monoclonal antibodies for uncontrolled asthma.PloS one · 2019Pooled it
- Potential Risks Related to Modulating Interleukin-13 and Interleukin-4 Signalling: A Systematic Review.Drug safety · 2018Pooled it
- Population pharmacokinetic analysis of sifalimumab from a clinical phase IIb trial in systemic lupus erythematosus patients.British journal of clinical pharmacology · 2016Trial
- Population pharmacokinetics of sifalimumab, an investigational anti-interferon-α monoclonal antibody, in systemic lupus erythematosus.Clinical pharmacokinetics · 2013Trial
- Safety, tolerability and pharmacokinetics of a human anti-interleukin-13 monoclonal antibody (CNTO 5825) in an ascending single-dose first-in-human study.British journal of clinical pharmacology · 2013Trial
- Targeting Interleukin 13 for the Treatment of Atopic Dermatitis.Pharmaceutics · 2023Review
- Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis.Clinical pharmacology in drug development · 2022Article
- Tralokinumab in Atopic Dermatitis: A Profile of Its Use.Clinical drug investigation · 2022Review
- Mechanistic modeling of a human IgGCPT: pharmacometrics & systems pharmacology · 2022Article
- Estimation of Clearance and Bioavailability of Therapeutic Monoclonal Antibodies from Only Subcutaneous Injection Data in Humans Based on Comprehensive Analysis of Clinical Data.Clinical pharmacokinetics · 2021Article
- Tralokinumab: First Approval.Drugs · 2021Review
- Machine Learning Attempts for Predicting Human Subcutaneous Bioavailability of Monoclonal Antibodies.Pharmaceutical research · 2021Article
- Simple Approach to Accurately Predict Pharmacokinetics of Therapeutic Monoclonal Antibodies after Subcutaneous Injection in Humans.Clinical pharmacokinetics · 2021Article
- A Novel Pharmacodynamic Biomarker and Mechanistic Modeling Facilitate the Development of Tovetumab, a Monoclonal Antibody Directed Against Platelet-Derived Growth Factor Receptor Alpha, for Cancer Therapy.The AAPS journal · 2020Article
- Predicting monoclonal antibody pharmacokinetics following subcutaneous administration via whole-body physiologically-based modeling.Journal of pharmacokinetics and pharmacodynamics · 2020Article
- Model-Based Discovery and Development of Biopharmaceuticals: A Case Study of Mavrilimumab.CPT: pharmacometrics & systems pharmacology · 2018Article
- Tralokinumab pharmacokinetics and tolerability when administered by different subcutaneous injection methods and rates .International journal of clinical pharmacology and therapeutics · 2017Article
- Exploratory Population PK Analysis of Dupilumab, a Fully Human Monoclonal Antibody Against IL-4Rα, in Atopic Dermatitis Patients and Normal Volunteers.CPT: pharmacometrics & systems pharmacology · 2016Article
- Physiologically-based pharmacokinetic modeling to predict the clinical pharmacokinetics of monoclonal antibodies.Journal of pharmacokinetics and pharmacodynamics · 2016Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo assess the bioavailability and pharmacokinetics of CAT-354, an anti-IL-13 human monoclonal IgG4 antibody, following subcutaneous (s.c.) and intravenous (i.v.) administration.
methodsThis was a single-dose, randomized, open-label, parallel-group bioavailability study. Healthy male subjects aged 20-54 years were randomly assigned to one of three dose groups (n= 10/group) to receive CAT-354: 150 mg i.v.; 150 mg s.c. or 300 mg s.c. (two 150 mg injections). Serum pharmacokinetics, adverse events (AEs), vital signs, electrocardiograms and laboratory parameters were assessed.
resultsCAT-354 showed bioavailability of 62% and 60% after 150 mg and 300 mg s.c. doses, respectively, and linear pharmacokinetics over the dose range tested. Peak serum concentrations in the s.c. groups occurred after 3-9 (median 5) days, with a mean elimination half-life of 19.2 +/- 3.1 days (150 mg) and 19.4 +/- 3.59 days (300 mg) after s.c. and 21.4 +/- 2.46 days after i.v. administration. Volume of distribution at steady state (V(ss)) was 4960 +/- 1440 ml kg(-1) after i.v. (slightly greater than plasma volume). Average apparent clearances (CL/F) were 292 +/- 82.3 and 307 +/- 109 ml day(-1) after 150 and 300 mg s.c., respectively; systemic CL of 188 +/- 84.0 ml day(-1) after i.v. dosing was consistent with endogenous IgG and reticuloendothelial elimination. No severe or serious AEs occurred. Among 40 reported AEs, 25 were headache, sinus disorders/respiratory symptoms and changes in body temperature perception.
conclusionsCAT-354 exhibited bioavailability of approximately 60% when given s.c. to healthy male subjects.
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Registered trials
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