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

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05930704
Collaborator
(none)
45
Enrollment
1
Location
2
Arms
20.8
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: SHR-2017 injection
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Jul 20, 2023
Anticipated Primary Completion Date :
Apr 12, 2025
Anticipated Study Completion Date :
Apr 12, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHR-2017 injection

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

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants with adverse events [From day 1 up to 9 months]

Secondary Outcome Measures

  1. Maximum observed concentration of SHR-2017 (Cmax) [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 [Day 1 pre-dose up to Day 253]

  3. Time to maximum observed concentration (Tmax) of SHR-2017 [Day 1 pre-dose up to Day 253]

  4. Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr) [Baseline up to Day 253]

  5. Percent change from baseline in serum Type I Collagen Carboxy-terminal Peptide (CTX) [Baseline up to Day 253]

  6. Percent change from baseline in Intact Parathyroid Hormone (iPTH) [Baseline up to Day 253]

  7. Percent change from baseline in Bone-Specific Alkaline Phosphatase (BALP) [Baseline up to Day 253]

  8. Number of subjects who developed SHR-2017 antidrug antibodies (ADA) [Baseline up to Day 253]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
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:

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Shandong First Medical University Jinan Shangdong China 250000

Sponsors and Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05930704
Other Study ID Numbers:
  • SHR-2017-101
First Posted:
Jul 5, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoporosis

Study Results

No Results Posted as of Jul 5, 2023