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

NCT05930704 | Unknown Phase 1

• 1 other identifier: SHR-2017-101
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  From day 1 up to 9 months

Secondary Outcomes (8)

• 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

Study Arms (2)

SHR-2017 injection

EXPERIMENTAL

Drug: SHR-2017 injection

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-2017 injection DRUG

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

SHR-2017 injection

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shangdong, 250000, China

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yuanyuan Huang

CONTACT

0518-82342973; yuanyuan.huang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: July 4, 2023
• Primary Completion: April 12, 2025
• Study Completion: April 12, 2025
• Last Updated: July 17, 2023

Record last verified: 2023-06

Locations

CN (1)