NCT06701149

A Comparative Study of the Pharmacokinetics of SIM0718 Injection in Healthy Adult Subjects in China

A Randomized, Open-label, Single-dose, Parallel Group Study to Compare the Pharmacokinetics of SIM0718 Injection in Healthy Adult Subjects in China

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Simcere Pharmaceutical Co., Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A study to compare the pharmacokinetics, safety and immunogenicity of SIM0718 injection in healthy adult subjects in China

Detailed description

This will be a single-center, open-label, single-dose, parallel group Comparative Study. After meeting the eligibility criteria, all eligible participants will be randomized 1:1to an experimental group (Rademikibart injection) or an Active Comparator (CBP-201 injection) as defined in the protocol. Randomization will be stratified by protocol defined body weight categories. The study will comprise: A Screening Period up to 28 days. One treatment period during which eligible participants will be admitted to the Clinical Unit on Day-1 to reassess their eligibility. Participants who meet eligibility criteria will be randomized to receive 300mg subcutaneous (SC) of Rademikibart injection or CBP-201 injection on Day 1. Participants will be discharged on Day 8. The participants will return to the center for Follow-up Visits on Days 10, 12, 15, 18, 22, 29, 36 43 and 57

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	Rademikibart injection	300 mg administered subcutaneously on the first day
DRUG	CBP-201 injection	300 mg administered subcutaneously on the first day

Timeline

• Start date: 2024-11-28
• Primary completion: 2025-05-22
• Completion: 2025-05-22
• First posted: 2024-11-22
• Last updated: 2026-04-03

Locations

1 site across 1 country: China