NCT05930704

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection Administered Subcutaneously to Postmenopausal Women

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The primary objective was to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous (SC) injection in postmenopausal women

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	SHR-2017 injection	Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.
DRUG	Placebo	Randomized participants will receive a single SC injection dose of matching placebo.

Timeline

• Start date: 2023-07-04
• Primary completion: 2025-04-12
• Completion: 2025-04-12
• First posted: 2023-07-05
• Last updated: 2023-07-17

Locations

1 site across 1 country: China