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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930704
• Other study ID #: SHR-2017-101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 4, 2023
• Est. completion date: April 12, 2025

Study information

• Verified date: June 2023
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Yuanyuan Huang
• Phone: 0518-82342973
• Email: yuanyuan.huang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 12, 2025
• Est. primary completion date: April 12, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• SHR-2017 injection
Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.
• Placebo
Randomized participants will receive a single SC injection dose of matching placebo.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shangdong

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		From day 1 up to 9 months
Secondary	Maximum observed concentration of SHR-2017 (Cmax)		Day 1 pre-dose up to Day 253
Secondary	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
Secondary	Time to maximum observed concentration (Tmax) of SHR-2017		Day 1 pre-dose up to Day 253
Secondary	Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr)		Baseline up to Day 253
Secondary	Percent change from baseline in serum Type I Collagen Carboxy-terminal Peptide (CTX)		Baseline up to Day 253
Secondary	Percent change from baseline in Intact Parathyroid Hormone (iPTH)		Baseline up to Day 253
Secondary	Percent change from baseline in Bone-Specific Alkaline Phosphatase (BALP)		Baseline up to Day 253
Secondary	Number of subjects who developed SHR-2017 antidrug antibodies (ADA)		Baseline up to Day 253