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Clinical trial

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

ID
Name
SHR-2017-101
Description
The primary objective was to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous (SC) injection in postmenopausal women
Trial arms
Trial start
2023-07-04
Estimated PCD
2025-04-12
Trial end
2025-04-12
Status
Recruiting
Phase
Early phase I
Treatment
SHR-2017 injection
Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.
Arms:
SHR-2017 injection
Placebo
Randomized participants will receive a single SC injection dose of matching placebo.
Arms:
Placebo
Size
45
Primary endpoint
Number of participants with adverse events
From day 1 up to 9 months
Eligibility criteria
Inclusion Criteria: 1. Postmenopausal women ages ≥ 50 years. 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: 1. History of malignancy. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}
Updated at
2023-07-17

1 organization

2 products

1 indication

Organization
Suzhou Suncadia Biopharmaceuticals
Product
Placebo
Indication
Osteoporosis
Product
SHR-2017