Revise protocol for Denosumab 60 mg prefilled syringe solution for injection: CDSCO Panel tells Lupin
New Delhi: In line with the proposal presented by Lupin for conducting phase I study of Denosumab 60 mg prefilled syringe solution for injection (60 mg/mL), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to revise the protocol with respect to inclusion of subjects in the study, excluding subjects from the study.
This came after the firm presented the proposal to conduct a Phase I study titled “An open label, randomized, single-dose, single-period, three treatment, parallel comparative pharmacokinetic, pharmacodynamic, and immunogenicity study of Lupin’s Denosumab 60 mg prefilled syringe solution for injection (60 mg/mL) with US and EU-approved Prolia (Denosumab) 60 mg solution for injection (60 mg/mL) in pre-filled syringe in healthy, adult, human male subjects” via Protocol No. LBC-P-097-24 dated 09.07.2024.
The expert panel suggested that serum calcium and vitamin D levels should be in a normal range for inclusion of subjects in the study. In addition, the committee stated that patients with histories of osteonecrosis of the jaw should be excluded from the study. Furthermore, the expert panel added that a serial assessment of levels of serum calcium and vitamin D should be done at each visit of the study subject.
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