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RecruitingNCT05930704Updated Jul 17, 2023

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

A Phase 1 interventional study of SHR-2017 injection and Placebo in Osteoporosis, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Recruiting at 1 site in China. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-07-17.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
50 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Osteoporosis

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03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's planned enrollment of 45 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 100 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    SHR-2017 injection

    Drug: SHR-2017 injection

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugSHR-2017 injection

    Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.

  • DrugPlacebo

    Randomized participants will receive a single SC injection dose of matching placebo.

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events

    Time frame: From day 1 up to 9 months

Secondary outcomes

  1. Maximum observed concentration of SHR-2017 (Cmax)

    Time frame: Day 1 pre-dose up to Day 253

  2. Area under the serum concentration time curve from time 0 to time of last quantifiable serum concentration (AUC0-t) of SHR-2017

    Time frame: Day 1 pre-dose up to Day 253

  3. Time to maximum observed concentration (Tmax) of SHR-2017

    Time frame: Day 1 pre-dose up to Day 253

  4. Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr)

    Time frame: Baseline up to Day 253

  5. Percent change from baseline in serum Type I Collagen Carboxy-terminal Peptide (CTX)

    Time frame: Baseline up to Day 253

  6. Percent change from baseline in Intact Parathyroid Hormone (iPTH)

    Time frame: Baseline up to Day 253

  7. Percent change from baseline in Bone-Specific Alkaline Phosphatase (BALP)

    Time frame: Baseline up to Day 253

  8. Number of subjects who developed SHR-2017 antidrug antibodies (ADA)

    Time frame: Baseline up to Day 253

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Shandong First Medical University
    Jinan, Shangdong 250000, China
    • Wei Zhao · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05930704
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Jul 5, 2023
Start date
Jul 4, 2023
Primary completion
Apr 12, 2025 (estimated)
Completion
Apr 12, 2025 (estimated)
Last update
Jul 17, 2023

Study contacts

Yuanyuan Huang
Contact
yuanyuan.huang@hengrui.com
0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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