Osteoporotic fracture
Conditions
Interventions
Single dose level 1-4:LYN101 or matched placebo SC
Multiple dose group:LYN101 or matched placebo SC subscquent 3 times
Sponsors
The First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Part A: Subjects must meet all of the following criteria to participate in this trial: 1 Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial, and sign a written informed consent form; 2 Individuals aged 18 to 65 years (inclusive), regardless of gender; 3 Weight >= 50 kg for males or at least 45 kg for females, with a Body Mass Index (BMI) ranging from 18.0 to 30.0 kg/m^2 (inclusive). 4 Males and females of childbearing potential agree to have no plans for childbearing and to use reliable contraceptive measures from signing the written informed consent until 6 months after dosing, and not to donate sperm or ova. Inclusion Criteria for Part B: 1 Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial, and sign a written informed consent form. 2 Individuals aged 50-70 years (inclusive), female, and ambulatory. 3 Spontaneous amenorrhea lasting for at least two years or bilateral oophorectomy performed at least two years prior. For women under 60 years of age who have undergone hysterectomy but retained their ovaries, or when bilateral oophorectomy status is unknown, menopausal status must be confirmed by follicle-stimulating hormone (FSH) levels exceeding 40 mIU/mL or in accordance with the postmenopausal range established by the local laboratory. 4 During the screening process, a minimum of two consecutive vertebrae within the L1-L4 region must be evaluable for DXA BMD assessment, and at least one hip must also be evaluable for DXA BMD assessment. 5 Low bone mass, as measured by Dual Energy X-ray Absorptiometry (DXA) during screening (BMD), shall meet the criteria at any site of a T-score less than -1.0 and greater than -2.5 at the lumbar spine L1-L4, femoral neck, or total hip.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Part A: 1 Systolic blood pressure (SBP) >= 140 mmHg and/or diastolic blood pressure (DBP) >= 90 mmHg following a minimum of five minutes of rest at the Screening assessments. 2 Clinically significant abnormalities observed in the 12-lead ECG at screening, including but not limited to: ? Mean QTcF > 450 ms (male) or 470 ms (female) (measured supine after resting for at least 10 minutes, 3 times with at least 1 minute interval); If the mean QTcF exceeds the above limit, repeat the ECG measurement 3 times; if the results of the retest are still abnormal, the subject is excluded. ? PR interval 200 ms 3 Clinically significant abnormalities in laboratory tests, chest X-ray, and/or abdominal ultrasound at Screening, unless determined by the Investigator to be non-interfering. 4 25-hydroxyvitamin D3 concentration 1.5 at Screening. 7 Corrected serum calcium and phosphorus concentrations outside the laboratory reference range at Screening (calcium and phosphorus supplements should not be used for at least 8 hours before serum calcium and phosphorus measurement). 8 Estimated creatinine clearance <60 mL/min (Cockcroft-Gault formula) at Screening. 9 Any disease that may affect the safety evaluation of the subject or the in vivo process of the investigational product, including the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematopoietic system, metabolic endocrine system, etc. 10 Participation in other drug or device clinical trials within 30 days or five half-lives (whichever is longer) prior to screening. 11 Use of prescription drugs within 14 days or five half-lives (whichever is longer) prior to investigational product administration, unless determined by the Investigator and Sponsor to be non-interfering (e.g., hormonal contraceptives). 12 Use of over-the-counter (OTC) drugs within 7 days or 5 half-lives (whichever is longer) prior to investigational product administration, unless determined by the Investigator and Sponsor to be non-interfering. 13 Test results indicate positivity for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody. 14 Use of more than 10 sticks per day of tobacco or nicotine products within the 30 days before screening. 15 History of alcohol abuse, drug abuse, or substance abuse within 12 months prior to screening. 16 Known allergy to human immunoglobulins, the investigational product or its components, calcium preparations, or vitamin D preparations. 17 Vaccination with a live vaccine (excluding influenza vaccine) within 4 weeks prior to screening, or planned vaccination with a live vaccine during the study. 18 Blood donation or blood loss of 400 mL or more within thirty days prior to screening. 19 Pregnant or breastfeeding women. 20 Any condition that, in the opinion of the Investigator, makes the subject unsuitable for enrollment or may interfere with the subject's participation or completion of the study. Exclusion Criteria for Part B: 1 Presence of bone metabolic diseases such as hypoparathyroidism, hyperparathyroidism, hypothyroidism, hyperthyroidism, hyp
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event, serious adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone turnover markers;Pharmacokinetics parameters;Immunogenicity; | — |
Countries
China
Contacts
Public ContactHuan Zhou
The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed