Trial reportAAPS PharmSciTech2015
Tolerability of High-Volume Subcutaneous Injections of a Viscous Placebo Buffer: A Randomized, Crossover Study in Healthy Subjects.
Trial report in AAPS PharmSciTech, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 30 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 59 citations in OpenAlex.
- Clinical Investigation of Large Volume Subcutaneous Delivery up to 25 mL for Lean and Non-Lean Subjects.Pharmaceutical research · 2024Trial
- Clinical Evaluation of an Investigational 5 mL Wearable Injector in Healthy Human Subjects.Clinical and translational science · 2021Trial
- Proof-of-Concept Development and Preclinical Evaluation of a Microarray Patch Platform for Codelivery of Multiple Broadly Neutralizing Antibodies for HIV Prevention.Molecular pharmaceutics · 2026Article
- Exploratory Analyses of Patient Preferences for Atezolizumab Subcutaneous Versus Intravenous from the IMscin002 Study in Patients with Non-Small Cell Lung Cancer.Oncology and therapy · 2026Article
- A phase I clinical study to evaluate rapid, high-volume, subcutaneous auto-injector tolerability with recombinant human hyaluronidase.Drug delivery and translational research · 2026Article
- Matching placebo development for injectable biologics-a practical tutorial.Antibody therapeutics · 2025Article
- Development and Preclinical Testing of a Rapid, High-Volume, Auto-Injector for Subcutaneous Administration with Recombinant Human Hyaluronidase.AAPS PharmSciTech · 2025Article
- TiDrug delivery and translational research · 2024Review
- Broadly neutralizing antibodies for HIV prevention: a comprehensive review and future perspectives.Clinical microbiology reviews · 2024Review
- Investigation into the Acceptability of Moderate-to-Large Volume Subcutaneous Injections in Healthy Volunteers: Results from a Single-Center Randomized Controlled Study.Medical devices (Auckland, N.Z.) · 2024Article
- Imaging of large volume subcutaneous deposition using MRI: exploratory clinical study results.Drug delivery and translational research · 2023Article
- In-line warming reduces in-line pressure of subcutaneous infusion of concentrated immunoglobulins.Drug delivery and translational research · 2023Article
- Characterization of large volume subcutaneous injections using computed tomography imaging and simultaneous pressure measurements.Frontiers in drug delivery · 2023Article
- Novel cannula design improves large volume auto-injection rates for high viscosity solutions.Drug delivery · 2022Article
- Poly(trehalose methacrylate) as an Excipient for Insulin Stabilization: Mechanism and Safety.ACS applied materials & interfaces · 2022Article
- Clinical evaluation of large volume subcutaneous injection tissue effects, pain, and acceptability in healthy adults.Clinical and translational science · 2022Article
- New insight into the importance of formulation variables on parenteral growth hormone preparations: potential effect on the injection-site pain.Frontiers in endocrinology · 2022Review
- Effect of Poly(trehalose methacrylate) Molecular Weight and Concentration on the Stability and Viscosity of Insulin.Macromolecular materials and engineering · 2021Article
- Multiphysics Modeling and Simulation of Subcutaneous Injection and Absorption of Biotherapeutics: Sensitivity Analysis.Pharmaceutical research · 2021Article
- Formative Study on the Wearability and Usability of a Large-Volume Patch Injector.Medical devices (Auckland, N.Z.) · 2021Article
Corrections and comments
- Erratum issued
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Monoclonal antibody biotherapeutics are often administered by subcutaneous (SC) injection. Due to dose requirements and formulation limitations, SC injections >1 mL are often required. We used a viscous placebo buffer (5 cP), characteristic of a high-concentration antibody formulation, to investigate the effect of dose volume and injection rate on the tolerability of higher-volume SC injections. In this randomized, crossover, single-center study, 48 healthy adults received one 1.2-mL bolus injection over 5 s and three 3.5-mL injections over 1, 4, and 10 min in different abdominal quadrants, with each injection separated by approximately 2 h. The primary objective was to compare pain scores associated with the injections, immediately after administration and 1 h later, using a 100-mm visual analog scale (VAS). Secondary objectives included assessment of adverse events, including injection site reactions and swelling. Mean age was 38.4 (11.6) years and 20 subjects (42%) were female. Lowest mean VAS score was for the 10-min (6.83 mm) and highest for the 1-min injection (19.13 mm). One hour after administration, mean VAS scores were <3.5 mm for all injections. Swelling was similar among the three 3.5-mL injections. After needle removal, leakage occurred following 14 (29%) 1.2-mL injections, eight (17%) 4-min injections, five (10%) 1-min injections, and four (8%) 10-min injections. Fifteen subjects (31%) experienced an adverse event, none of which was serious, fatal, or led to study discontinuation. All injection durations were well tolerated, suggesting a single large-volume SC injection of a biotherapeutic agent could be used instead of multiple injections.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.