Syngene International Gets CDSCO Panel Nod To study Trinbelimab Injection
New Delhi: Based on the Phase I clinical trial protocol presented by the drug major Synegene International to evaluate the pharmacokinetics and tolerability of Trinbelimab (recombinant anti-rho-d immunoglobulin) of Bharat Serums and Vaccines Ltd., India in healthy, adult, rhesus negative postmenopausal female subjects, the Subject Expert Committee (SEC) of the Central Standard Drug Organisation (CDSCO) has opined the firm to conduct the Phase I study.
However, the nod came with conditions that the title of the study should be amended to include Rh-D negative non sensitized postmenopausal female subjects.
Furthermore, the expert panel suggested that the exclusion criteria should be modified so that Rh-D negative sensitized women are excluded from participation in the study.
This came after the firm presented the Phase I protocol titled “A prospective, single-dose, single-period study to evaluate the pharmacokinetics and tolerability of Trinbelimab (recombinant anti-rho-d immunoglobulin) of Bharat Serums and Vaccines Ltd., India in healthy, adult, rhesus negative postmenopausal female subjects” vide protocol no SYNCD-003-23 version no 2.00 dated 10.04.2023.
Trinbelimab is in a class of medications called monoclonal antibodies. It prevents antibodies from forming after a person with Rh-negative blood receives a transfusion with Rh-positive blood, or during pregnancy when a mother has Rh-negative blood and the baby is Rh-positive.
At the recent SEC meeting Reproductive & Urology held on 20th July 2023, the expert panel reviewed the Phase I protocol titled “A prospective, single-dose, single-period study to evaluate the pharmacokinetics and tolerability of Trinbelimab (recombinant anti-rho-d immunoglobulin) of Bharat Serums and Vaccines Ltd., India in healthy, adult, rhesus negative postmenopausal female subjects” vide protocol no SYNCD-003-23 version no 2.00 dated 10.04.2023.
After detailed deliberation, the committee recommended conducting the Phase I study subject to the following changes in the protocol-
1. The title should be amended to include Rh-D negative non-sensitized postmenopausal female subjects.
2. The exclusion criteria should be modified so that Rh-D negative sensitized women are excluded from participation in the study.
Accordingly, the committee suggested that the firm should submit a revised protocol to CDSCO for further approval.
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