Trials / Completed
CompletedNCT04435158
A Multiple Dose Study to Evaluate the Effect of SHR-1222 Injection in Postmenopausal Osteoporosis Patients
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity Study Following Multiple Subcutaneous Injections of SHR-1222 in Postmenopausal Osteoporosis Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 50 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a Multi-Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics, Immunogenicity with Multiple Subcutaneous Injections of SHR-1222 in Postmenopausal Osteoporosis Patients. The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1222 in postmenopausal osteoporosis patients. Secondary objectives are to determine the pharmacokinetics (PK), pharmacodynamics (PD) profile of SHR-1222 in postmenopausal osteoporosis patients including assessment of immunogenicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1222 | Pharmaceutical form: water injection Route of administration: subcutaneous injection |
| DRUG | Placebo | Pharmaceutical form: water injection Route of administration: subcutaneous injection |
Timeline
- Start date
- 2020-08-25
- Primary completion
- 2022-07-18
- Completion
- 2022-07-18
- First posted
- 2020-06-17
- Last updated
- 2023-07-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04435158. Inclusion in this directory is not an endorsement.