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

Phase 1

Recruiting

• Conditions: Osteoporosis
• Interventions: Drug: SHR-2017 injection; Drug: Placebo

• Registration Number: NCT05930704
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Study Start: 2023-07-04
• Study First Posted: 2023-07-05
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17
• Primary Completion: 2025-04-12
• Study Completion: 2025-04-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-2017 injection	SHR-2017 injection	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	From day 1 up to 9 months

Secondary Outcome Measures

Name	Time	Method
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
Maximum observed concentration of SHR-2017 (Cmax)	Day 1 pre-dose 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 Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr)	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
Time to maximum observed concentration (Tmax) of SHR-2017	Day 1 pre-dose up to Day 253
Percent change from baseline in Intact Parathyroid Hormone (iPTH)	Baseline up to Day 253

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shangdong, China