Trial reportThe AAPS journal2018
Measurement of IL-17AA and IL-17FF as Pharmacodynamic Biomarkers to Demonstrate Target Engagement in the Phase I Study of MCAF5352A.
Trial report in The AAPS journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 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
5 citing papers in PubMed.
- A Generalized Minimal PBPK-PD Model of Bispecific Antibodies: Case Studies and Applications in Drug Development.CPT: pharmacometrics & systems pharmacology · 2026Article
- The Development and Characterization of a Highly Sensitive Mature TGFβ3 Assay to Evaluate Anti-TGFβ3 Target Engagement.The AAPS journal · 2023Article
- Article
- Exploring antibody repurposing for COVID-19: beyond presumed roles of therapeutic antibodies.Scientific reports · 2021Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The interleukin (IL)-17 pathway has been implicated in the pathophysiology of many autoimmune diseases. MCAF5352A is a humanized monoclonal antibody which targets both IL-17A and IL-17F, thereby inhibiting the activity of IL-17 dimers (IL-17AA, IL-17AF, and IL-17FF). The pharmacokinetic profile of MCAF5352A has been characterized in both a Phase Ia single ascending dose study and a Phase Ib multiple ascending dose study. Two qualified enzyme-linked immunosorbent assays were used to measure total IL-17AA and IL-17FF levels in serum as pharmacodynamic biomarkers in the Phase I studies. The two assays demonstrated specificity for IL-17AA or IL-17FF with sensitivity at low picogram/milliliter levels. The assay precision and accuracy also met acceptance criteria. Although total serum IL-17AA and IL-17FF levels were below the assay detection limits prior to administration of MCAF5352A, post-treatment levels in both the single and multiple dose cohorts became detectable and increased in a dose-dependent manner. These data are consistent with target engagement by MCAF5352A. Our work highlights bioanalytical challenges encountered while developing biomarker assays requiring high sensitivity and specificity. Data generated using these assays enabled the confirmation of target engagement during early clinical drug development.
Indexed as
Identifiers
30547287What 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.