Trial reportClinical and translational science2024
MB09, a denosumab biosimilar candidate: Biosimilarity demonstration in a phase I study in healthy subjects.
Trial report in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 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
4 citing papers in PubMed.
- Comparison of pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a candidate biosimilar INTP23.1 with EU and US‑approved denosumab reference products in healthy adult men.Naunyn-Schmiedeberg's archives of pharmacology · 2026Trial
- MB09, a denosumab biosimilar candidate: Biosimilarity demonstration in a phase I study in healthy subjects.Clinical and translational science · 2024Trial
- Phase III Study to Confirm Clinical Similarity of MB09, a Denosumab Biosimilar, and ProliaPharmaceutics · 2026Article
- Population PK Modeling of Denosumab Biosimilar MB09 and Reference Denosumab to Establish PK Similarity.Pharmaceutics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This was a Phase I, randomized, double-blinded, three-arm, single-dose, parallel study aimed to demonstrate pharmacokinetic (PK) similarity between MB09 (a denosumab biosimilar candidate) and reference denosumab (XGEVA® from European Union [EU-reference] and United States [US-reference]) in a healthy male population. The primary PK endpoints included: Area under the serum concentration versus time curve from time 0 to the last quantifiable concentration timepoint (AUC
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.