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

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

Non Recruiting
50 years and older
Female
Phase 1

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Overview

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

Eligibility

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.

Study details
    Osteoporosis

NCT05930704

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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