Trial reportDrug design, development and therapy2026
Phase I Study Evaluating Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Recombinant Human Serum Albumin (rHSA) in Healthy Adults.
Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Methodological Considerations in the Bioequivalence Assessment of Recombinant Human Serum Albumin [Letter].Drug design, development and therapy · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: To compare the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of recombinant human serum albumin (rHSA) with plasma-derived human serum albumin (pdHSA) following intravenous administration to healthy adults. Patients and Methods: This Phase I study enrolled 62 healthy adults aged 18-45 years in two sequential parts. Part 1 (n=12) evaluated safety and tolerability of rHSA using a single ascending dose design (10 g, 20 g and 40 g) with 3 cohorts. Based on these outcomes, Part 2 (n=50) was conducted as a randomized (1:1), active-controlled, parallel-group study comparing rHSA with pdHSA (Flexbumin® 20%) administered at escalating doses (10 g, 20 g, and 40 g) with 3-week intervals. Primary PK endpoints were C Results: In Part 1, rHSA was tolerated up to 40 g as single dose, and at cumulative dose of 70 g in part 2, with no dose-limiting toxicities. PK and PD profiles were comparable between test rHSA and pdHSA, with geometric mean ratios for C Conclusion: The test rHSA was well tolerated at cumulative doses of 70 g and demonstrated comparable PK, PD, safety and immunogenicity profiles to pdHSA, supporting its potential as a viable alternative.
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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.