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

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

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: SHR-2017 injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yuanyuan Huang; Phone Number: 0518-82342973; Email: yuanyuan.huang@hengrui.com

Study Locations

• China
  • Shangdong
    • Jinan, Shangdong, China, 250000
      • Recruiting
      • The First Affiliated Hospital of Shandong First Medical University
      • Principal Investigator: Wei Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Randomized participants will receive a single SC injection dose of matching placebo.
Experimental: SHR-2017 injection	Drug: SHR-2017 injection; Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	From day 1 up to 9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration of SHR-2017 (Cmax)	Day 1 pre-dose up to Day 253
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
Time to maximum observed concentration (Tmax) of SHR-2017	Day 1 pre-dose up to Day 253
Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr)	Baseline up to Day 253
Percent change from baseline in serum Type I Collagen Carboxy-terminal Peptide (CTX)	Baseline up to Day 253
Percent change from baseline in Intact Parathyroid Hormone (iPTH)	Baseline up to Day 253
Percent change from baseline in Bone-Specific Alkaline Phosphatase (BALP)	Baseline up to Day 253
Number of subjects who developed SHR-2017 antidrug antibodies (ADA)	Baseline up to Day 253

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2023
• Primary Completion (Estimated): April 12, 2025
• Study Completion (Estimated): April 12, 2025

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: SHR-2017-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No