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Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

NCT05930704•Suzhou Suncadia Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

50 - No limit years

Sex

FEMALE

Healthy Volunteers

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.

Locations (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shangdong, China

Key Dates

Start Date

July 4, 2023

Primary Completion Date

April 12, 2025

Completion Date

April 12, 2025

Last Updated

July 17, 2023

Enrollment

ESTIMATED participants

Conditions

Osteoporosis

Interventions

SHR-2017 injection

DRUG

Placebo

DRUG

Contacts

Yuanyuan Huang

CONTACT

0518-82342973 yuanyuan.huang@hengrui.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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