Conditions: Healthy Volunteer
Keywords: denosumab, bioequivalence
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 146
Healthy volunteers: yes

Brief summary:
To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.

Detailed description:

Arms:
arm 1: Participants received a single dose of 120 mg denosumab manufactured using the new CP4 process subcutaneously on day 1. arm 2: Participants received a single dose of 120 mg denosumab manufactured using the current CP2 process subcutaneously on day 1.

Interventions: intervention 1: Denosumab CP4 intervention 2: Denosumab CP2
Intervention descriptions: intervention 1: Denosumab produced by a process referred to as CP4, administered subcutaneously. intervention 2: Denosumab produced by a process referred to as CP2, administered subcutaneously.

Protocol document: