BP16 (denosumab biosimilar) / Aurobindo - LARVOL DELTA

A Study to Compare the Pharmacokinetic, Pharmacodynamics, safety, Tolerability and Immunogenicity of BP16 versus Prolia (US and EU approved) in Healthy male Volunteers. (ANZCTR) - P1 | N=204 | Completed | Sponsor: CuraTeQ Biologics Private Ltd. | Recruiting ➔ Completed

Trial completion • Osteoporosis • Rheumatology

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab (Indian Pharma Post) - P1 | N=204 | "CuraTeQ Biologics Private Limited...has announced that its denosumab biosimilar, BP16, has successfully met the primary endpoints in a comprehensive pharmacokinetic (PK) and pharmacodynamic (PD) study. This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets....Additionally, BP16 demonstrated comparable pharmacodynamics, safety, and immunogenicity profiles to both EU and US versions of the reference product....'With the positive Phase 1 study results, we are optimistic about our ongoing Phase 3 study. This study is progressing across multiple sites in the EU, focusing on women with postmenopausal osteoporosis, and we anticipate its completion by May/June 2025,'..."

New P3 trial • P1 data • PK/PD data • Osteoporosis

A Study to Compare the Pharmacokinetic, Pharmacodynamics, safety, Tolerability and Immunogenicity of BP16 versus Prolia (US and EU approved) in Healthy male Volunteers. (ANZCTR) - P1 | N=204 | Recruiting | Sponsor: CuraTeQ Biologics Private Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2023

Enrollment open • Trial initiation date • Osteoporosis • Rheumatology

A Study to Compare the Pharmacokinetic, Pharmacodynamics, safety, Tolerability and Immunogenicity of BP16 versus Prolia (US and EU approved) in Healthy male Volunteers. (ANZCTR) - P1 | N=204 | Not yet recruiting | Sponsor: CuraTeQ Biologics Private Ltd.

New P1 trial • Osteoporosis • Rheumatology