Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women
NCT ID: NCT05930704
Last Updated: 2023-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
45 participants
INTERVENTIONAL
2023-07-04
2025-04-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The PK/PD Study of A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects
NCT03870100
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects
NCT05369767
A Phase I Study of SHR -2001 in Healthy Subjects
NCT05942612
Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Injection of SHR-2173 in Healthy Subjects
NCT06995001
Safety and Tolerability of SHR-1918 in Healthy Subjects
NCT05432544
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SHR-2017 injection
SHR-2017 injection
Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.
Placebo
Placebo
Randomized participants will receive a single SC injection dose of matching placebo.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SHR-2017 injection
Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.
Placebo
Randomized participants will receive a single SC injection dose of matching placebo.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Body weight≥45 kg, body mass index (BMI) of 18.0 to 29.0 kg/m2 (inclusive).
3. Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).
Exclusion Criteria
2. Menopause due to simple hysterectomy.
3. Subjects with poor blood pressure control.
4. Subjects with positive tests for infectious diseases.
5. Have a history of diseases related to bone metabolism.
6. Use of drugs that may affect bone metabolism before administration.
7. Have a history of alcoholism, medical abuse, or drug use, or have a positive alcohol breath test or drug abuse screening.
8. Female who are pregnant or breastfeeding.
9. Unable to tolerate venipunctures or have a history of fainting needles and blood.
10. Other reasons that the investigator consider it inappropriate to participate in the trial.
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHR-2017-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.