A Multiple Dose Study to Evaluate the Effect of SHR-1222 Injection in Postmenopausal Osteoporosis Patients

NCT04435158 | Completed Phase 1

• 1 other identifier: SHR-1222-102
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Multi-Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics, Immunogenicity with Multiple Subcutaneous Injections of SHR-1222 in Postmenopausal Osteoporosis Patients. The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1222 in postmenopausal osteoporosis patients. Secondary objectives are to determine the pharmacokinetics (PK), pharmacodynamics (PD) profile of SHR-1222 in postmenopausal osteoporosis patients including assessment of immunogenicity.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerance: Number of subjects with adverse events

  Number \& proportion of subjects with adverse events

  Dose administration to 225 days after first dose administration

Secondary Outcomes (13)

• Assessment of PK parameter-time to maximum concentration (Tmax)

  Pre-dose to 225 days after first dose administration

• Assessment of PK parameter-maximum concentration (Cmax)

  Pre-dose to 225 days after first dose administration

• Assessment of PK parameter-area under curve (AUC)

  Pre-dose to 225 days after first dose administration

• Assessment of PD parameter-change in serum C-telopeptide (sCTx) from baseline

  Pre-dose to 225 days after first dose administration

• Assessment of PD parameter-change in aminoterminal propeptide type-1 procollagen (P1NP) from baseline

  Pre-dose to 225 days after first dose administration

Study Arms (6)

Cohort 1：SHR-1222

EXPERIMENTAL

Subcutaneous injection of SHR-1222 dosage 1 monthly × 6 months

Drug: SHR-1222

Cohort 2：SHR-1222

EXPERIMENTAL

Subcutaneous injection of SHR-1222 dosage 2 monthly × 6 months

Drug: SHR-1222

Cohort 3：SHR-1222

EXPERIMENTAL

Subcutaneous injection of SHR-1222 dosage 3 monthly × 6 months

Drug: SHR-1222

Cohort 4：SHR-1222

EXPERIMENTAL

Subcutaneous injection of SHR-1222 dosage 4 every 2 months × 6 months

Drug: SHR-1222

Cohort 5：SHR-1222

EXPERIMENTAL

Subcutaneous injection of SHR-1222 dosage 5 every 2 months × 6 months

Drug: SHR-1222

Cohort 6：placebo

EXPERIMENTAL

Subcutaneous injection of placebo × 6 months

Drug: Placebo

Interventions

SHR-1222 DRUG

Pharmaceutical form: water injection Route of administration: subcutaneous injection

Cohort 1：SHR-1222; Cohort 2：SHR-1222; Cohort 3：SHR-1222; Cohort 4：SHR-1222; Cohort 5：SHR-1222

Placebo DRUG

Pharmaceutical form: water injection Route of administration: subcutaneous injection

Cohort 6：placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• Age ≥50 and ≤70 years old and post menopause for at least 5 years at the time of screening;
• Weight ≥40kg at the time of screening;
• BMD T-score ≤ -2.50 at the lumbar vertebrae, total hip or femoral neck at the time of screening, based on DXA scans;
• At least 2 vertebrae in the L1-L4 region and at least one hip are evaluable by DXA;
• Without disease that would significantly affect the study or bring additional health risks at the time of screening or baseline; blood pressure \< 150 / 95mmHg, blood fasting blood glucose \< 7.0mmol/l, glycosylated hemoglobin \< 7%, or total cholesterol \< 6.2mmol/l, triglyceride \< 3.4mmol/l under the condition of lifestyle improvement rather than drug treatment; If there are other abnormalities in the examination report of the subject, the subject could only be included after investigator approval;
• Ambulatory.

You may not qualify if:

• Any disease affecting bone metabolism;
• Any severe (SQ3) or more than 2 moderate (SQ2) vertebral fractures, as assessed by the central imaging based on lateral spine x-rays at the time of screening;
• History of hip fracture;
• (OH) vitamin D levels \< 20 ng/mL at the time of screening. Vitamin D repletion will be permitted and subjects may be rescreened;
• BMD T-score \< -3.50 at the lumber vertebra, total hip or femoral neck at the time of screening, based on DXA scans;
• Use of the following agents affecting bone metabolism:
• IV bisphosphonates or denosumab prior to screening;
• Oral bisphosphonates, PTH analogs, Strontium or fluoride within 12m prior to screening;
• Hormone replacement therapy within 6m prior to screening;
• Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed), Anabolic steroids, Calcitriol and available analogues, thiazide diuretics within 3m prior to screening;
• History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as hyperprolactinemia, osteosclerosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome;
• Hyperparathyroidism, hypothyroidism, hyperthyroidism, hypothyroidism, hypercalcemia, hypocalcemia, renal failure, etc at the time of screening;
• Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years;
• A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs;
• Past medical history of cerebral infarction, ischemic or hemorrhagic stroke;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

2nd Xiangya Hospital , Chinese Academy of Medical Sciences

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhiguang Zhou

  2nd Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 17, 2020
• Study Start: August 25, 2020
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

CN (1)