Back to resultsStudy to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women
Primary Purpose
Osteoporosis
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR-2017 injection
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria: Postmenopausal women ages ≥ 50 years. Body weight≥45 kg, body mass index (BMI) of 18.0 to 29.0 kg/m2 (inclusive). Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF). Exclusion Criteria: History of malignancy. Menopause due to simple hysterectomy. Subjects with poor blood pressure control. Subjects with positive tests for infectious diseases. Have a history of diseases related to bone metabolism. Use of drugs that may affect bone metabolism before administration. Have a history of alcoholism, medical abuse, or drug use, or have a positive alcohol breath test or drug abuse screening. Female who are pregnant or breastfeeding. Unable to tolerate venipunctures or have a history of fainting needles and blood. Other reasons that the investigator consider it inappropriate to participate in the trial.
Sites / Locations
- The First Affiliated Hospital of Shandong First Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SHR-2017 injection
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with adverse events
Secondary Outcome Measures
Maximum observed concentration of SHR-2017 (Cmax)
Area under the serum concentration time curve from time 0 to time of last quantifiable serum concentration (AUC0-t) of SHR-2017
Time to maximum observed concentration (Tmax) of SHR-2017
Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr)
Percent change from baseline in serum Type I Collagen Carboxy-terminal Peptide (CTX)
Percent change from baseline in Intact Parathyroid Hormone (iPTH)
Percent change from baseline in Bone-Specific Alkaline Phosphatase (BALP)
Number of subjects who developed SHR-2017 antidrug antibodies (ADA)
Full Information
NCT ID
NCT05930704
First Posted
June 26, 2023
Last Updated
July 13, 2023
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05930704
Brief Title
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2023 (Actual)
Primary Completion Date
April 12, 2025 (Anticipated)
Study Completion Date
April 12, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-2017 injection
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR-2017 injection
Intervention Description
Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Randomized participants will receive a single SC injection dose of matching placebo.
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
From day 1 up to 9 months
Secondary Outcome Measure Information:
Title
Maximum observed concentration of SHR-2017 (Cmax)
Time Frame
Day 1 pre-dose up to Day 253
Title
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
Title
Time to maximum observed concentration (Tmax) of SHR-2017
Time Frame
Day 1 pre-dose up to Day 253
Title
Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr)
Time Frame
Baseline up to Day 253
Title
Percent change from baseline in serum Type I Collagen Carboxy-terminal Peptide (CTX)
Time Frame
Baseline up to Day 253
Title
Percent change from baseline in Intact Parathyroid Hormone (iPTH)
Time Frame
Baseline up to Day 253
Title
Percent change from baseline in Bone-Specific Alkaline Phosphatase (BALP)
Time Frame
Baseline up to Day 253
Title
Number of subjects who developed SHR-2017 antidrug antibodies (ADA)
Time Frame
Baseline up to Day 253
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postmenopausal women ages ≥ 50 years.
Body weight≥45 kg, body mass index (BMI) of 18.0 to 29.0 kg/m2 (inclusive).
Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).
Exclusion Criteria:
History of malignancy.
Menopause due to simple hysterectomy.
Subjects with poor blood pressure control.
Subjects with positive tests for infectious diseases.
Have a history of diseases related to bone metabolism.
Use of drugs that may affect bone metabolism before administration.
Have a history of alcoholism, medical abuse, or drug use, or have a positive alcohol breath test or drug abuse screening.
Female who are pregnant or breastfeeding.
Unable to tolerate venipunctures or have a history of fainting needles and blood.
Other reasons that the investigator consider it inappropriate to participate in the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanyuan Huang
Phone
0518-82342973
Email
yuanyuan.huang@hengrui.com
Facility Information:
Facility Name
The First Affiliated Hospital of Shandong First Medical University
City
Jinan
State/Province
Shangdong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhao
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women
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