ArticleFrontiers in pharmacology2025
Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial.
Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05576454 (A Randomized, Double-blinded, Single-dose, 3-arm Parallel Comparative Study on Pharmacokinetics and Safety of BAT2606 Injection Versus Mepolizumab Injection), which is not on this map. Not yet cited in PubMed.
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.
A Randomized, Double-blinded, Single-dose, 3-arm Parallel Comparative Study on Pharmacokinetics and Safety of BAT2606 Injection Versus Mepolizumab Injection (EU-licensed Nucala® and US-licensed Nucala®) in Healthy Chinese Male Subjects
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: To evaluate the similarity of BAT2606 and mepolizumab, including pharmacokinetic profiles, immunogenicity, and safety, in healthy Chinese men. Methods: This randomized, double-blind, parallel three-arm, single-dose Phase I clinical study enrolled 207 subjects. All subjects enrolled in this study were randomly assigned to receive BAT2606 or mepolizumab (European-sourced Nucala [Nucala-EU] and US-sourced Nucala [Nucala-US]) at a 1:1:1 ratio. In total, 206 subjects received a subcutaneous injection of 100 mg of one of the drugs in this study. Results: The mean drug concentration-time curves were similar among the three groups. The 90% confidence intervals of the geometric mean ratios of maximum concentration and area under the curve from time 0 to infinity were within 80.00%-125.00%. There were no adverse events leading to study discontinuation or death, no serious adverse events, and no local injection-site reactions. The rates of adverse events and treatment-related adverse events were comparable among the BAT2606 (78.3% and 66.7%, respectively), Nucala-US (76.5% and 64.7%, respectively), and Nucala-EU groups (82.6% and 71.0%, respectively). The majority of treatment-related adverse events were grade 1 or 2 in severity based on Common Terminology Criteria for Adverse Events version 5.0. Anti-drug antibodies (ADAs) were detected in 4 (5.8%), 10 (14.7%), and 10 subjects (14.5%) in the BAT2606, Nucala-US, and Nucala-EU groups, respectively. All subjects with a positive ADA result were negative for neutralizing antibodies. Conclusion: BAT2606 injection was pharmacokinetically bioequivalent to Nucala-US and Nucala-EU in healthy Chinese men. BAT2606 was well tolerated, and its overall safety profile was similar to those of Nucala-US and Nucala-EU. BAT2606 had a numerically lower ADA incidence than Nucala-US and Nucala-EU. Clinical Trial Registration: https://www.clinicaltrials.gov/study/NCT05576454?term=BAT2606&rank=1.
Indexed as
Identifiers
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.