A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens

Official title

Evaluation of the Safety and Efficacy of SAL056 (Recombinant Human Parathyroid Hormone [1-34] for Injection [56.5 μg]) at Different Doses and Dosing Regimens: A Multicenter, Randomized, Open-Label, Parallel-Controlled Phase II Clinical Trial

Overview

This is a multicenter, randomized, open-label, parallel-controlled Phase II study designed to evaluate the differences in safety among four different dosing regimens of SAL056.

Detailed description

This study will randomly assign 200 eligible trial participants to either the intervention group or the control group, with each treatment group receiving an 8-week course of the investigational drug. By comparing the incidence of safety events between the groups at the end of the treatment period, the safety differences among the four different medication regimens will be evaluated.

The study is primarily divided into a screening period (up to 4 weeks before administration), a treatment period (8 weeks), and a safety follow-up period of 1 week, requiring a total of 7 visits.

Interventions

• Drug SAL056 56.5μg
  SAL056 56.5μg administered once weekly for 8 weeks
• Drug Intervention Group 1
  Teriparatide Injection daily formulation administered for 2 weeks, followed by SAL056 for 6 weeks.
• Drug Intervention Group 2
  Teriparatide Injection daily formulation administered for 4 weeks, followed by SAL056 for 4 weeks.
• Drug Intervention Group 3
  SAL056 28.2μg administered twice weekly for 8 weeks.

Primary outcome measures

• The incidence of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) between each intervention group and the control group during the treatment period，about 10weeks [Time frame: during the treatment period，about 10 weeks]

Eligibility criteria

Inclusion criteria

1.Female, with independent mobility, 45 years ≤ age ≤ 80 years; 2.Natural menopause for ≥3 years, or surgical menopause for ≥3 years (surgery must be performed after age 40); for women with surgical menopause, follicle-stimulating hormone >40 mIU/mL is required; 3.18 ≤ body mass index ≤ 30 kg/m²; 4.Previous definitive diagnosis of osteoporosis; 5.Patients who are able to independently go to the hospital to receive injections of the investigational drug; 6. Voluntarily participate in this trial and sign the informed consent form.

Exclusion criteria

• Received teriparatide treatment within 1 month prior to screening;
• Patients with secondary osteoporosis, such as Cushing's syndrome, hyperprolactinemia, malabsorption syndrome or various gastrointestinal diseases related to malabsorption (such as Crohn's disease, chronic pancreatitis, etc.), rheumatoid arthritis, gout, multiple myeloma, etc.;
• Patients with other diseases affecting calcium or bone metabolism, including hyperparathyroidism or hypoparathyroidism, hyperthyroidism or hypothyroidism (patients with hyperthyroidism or hypothyroidism receiving stable treatment with normal hormone levels are eligible; or patients with hypothyroidism where 5.5 mIU/L < thyroid-stimulating hormone ≤ 10.0 mIU/L but free thyroxine is within normal range are eligible), osteogenesis imperfecta, osteomalacia, Paget's disease of bone, hypercalcemia, hypocalcemia, active urolithiasis, etc.;
• Patients who require treatment with other anti-osteoporosis drugs during the trial or long-term/continuous use of digitalis glycosides such as digoxin;
• Patients with severe renal disease (serum creatinine >1.5 times the upper limit of normal), uncontrolled hypertension \[systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg\], severe heart disease (such as myocardial infarction, unstable angina pectoris, heart failure with NYHA functional class III-IV, severe arrhythmias, etc.), cerebral infarction (excluding lacunar cerebral infarction) or occlusive arteriosclerosis, malignant tumors, and those with other serious underlying diseases;
• Patients with esophageal abnormalities that cause delayed esophageal emptying (such as reflux esophagitis, esophageal stricture or achalasia) or those with difficulty swallowing;
• Abnormal laboratory findings detected during the screening period, including any of the following abnormal indicators:

1\) Alkaline phosphatase >1.3 times the upper limit of normal; 2) Alanine aminotransferase or aspartate aminotransferase >3.0 times the upper limit of normal; 3)Total bilirubin >1.5 times the upper limit of normal; 4) Glycated hemoglobin ≥8.5%; 5)White blood cell count <3.0×10⁹/L, or hemoglobin <100g/L, or platelet count <90×10⁹/L; 6)Parathyroid hormone >1.5 times the upper limit of normal; 8. Positive for hepatitis C virus antibody, or Treponema pallidum antibody, or human immunodeficiency virus antibody; or positive for hepatitis B surface antigen (HBsAg) with peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer ≥1×103 copies/mL (if HBsAg is positive and peripheral blood HBV DNA titer <1×103 copies/mL, the trial participant is eligible if the investigator considers the participant's chronic hepatitis B to be in a stable phase and will not increase the risk to the trial participant); 9. History of major surgery (excluding fracture surgery) within 6 months prior to signing the informed consent form, or planned major surgery during the study period; 10. Known history of organ transplantation; 11. History of drug abuse within 6 months prior to informed consent; 12. Individuals with known allergy to the investigational drug; 13. Patients who have previously received radiation therapy to the skeletal system; 14. Individuals with mental illness or cognitive impairment due to any cause; 15. Patients deemed unsuitable to participate in this study by researchers based on risk-benefit considerations.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Peking University Third Hospital — Beijing

Identifiers

NCT: NCT07579936 · SAL056A202

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗