Shilpa Medicare successfully completes Phase 1 clinical trial for Recombinant Human Albumin 20%
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-08-08 10:51 GMT | Update On 2024-08-08 10:51 GMT
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Karnataka: Shilpa Medicare Limited has announced the successful completion of its Phase 1 clinical trial for recombinant human albumin 20% (rHA). The positive results demonstrates rHA potential as a viable alternative to plasma derived human serum albumin. The Phase 1 clinical study is a randomized, dose-escalating, comparative trial against European sourced human derived serum albumin, involving 62 healthy volunteers. The trial aimed to evaluate the safety, efficacy, and pharmacokinetics of rHA at different dose levels.
Key findings from the study include:
Clinical Benefit: rHA demonstrated clinical benefits through surrogate endpoints such as colloidal osmotic pressure and hematocrit ratio, comparable to human-derived albumin.
Safety: rHA was generally well-tolerated, with no serious adverse events reported.
Immunogenicity: There was no significant difference in the incidence of anti-drug antibodies compared to human-derived albumin.
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