Clinical trial NCT05930704: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 45
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: From day 1 up to 9 months
Secondary outcomes:
measure: Maximum observed concentration of SHR-2017 (Cmax)
timeFrame: Day 1 pre-dose up to Day 253
measure: Area under the serum concentration time curve from time 0 to time of last quantifiable serum concentration (AUC0-t) of SHR-2017
timeFrame: Day 1 pre-dose up to Day 253
measure: Time to maximum observed concentration (Tmax) of SHR-2017
timeFrame: Day 1 pre-dose up to Day 253
measure: Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr)
timeFrame: Baseline up to Day 253
measure: Percent change from baseline in serum Type I Collagen Carboxy-terminal Peptide (CTX)
timeFrame: Baseline up to Day 253
measure: Percent change from baseline in Intact Parathyroid Hormone (iPTH)
timeFrame: Baseline up to Day 253
measure: Percent change from baseline in Bone-Specific Alkaline Phosphatase (BALP)
timeFrame: Baseline up to Day 253
measure: Number of subjects who developed SHR-2017 antidrug antibodies (ADA)
timeFrame: Baseline up to Day 253
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shangdong
Study officials:
References: