Osteoporosis
Conditions
Brief summary
This is a placebo-controlled, single-ascending dose, multicenter Phase I clinical study to evaluate the safety, tolerability, PK and PD characteristics of a single intravenous infusion of TST002 in subjects with reduced bone mineral density.
Detailed description
Four single dose cohorts are designed in this study, ascending with phase I dose-escalation principles as following: 200mg, 400mg (100%), 800mg (100%), and 1200mg (50%). 8 subjects will be enrolled in each cohort, 6 for TST002 injection and 2 for placebo. Only ≤3 male subjects could be enrolled in each cohort. Subjects in each dose group were randomized to receive TST002 or placebo in a ratio of 3:1.
Interventions
DRUGTST002 Injection
This single dose study, ascending with phase I dose-escalation principles from 200mg up to 1200mg.
DRUGplacebo
This single dose study, ascending with phase I dose-escalation principles from 200mg up to 1200mg.
Sponsors
HJB (Hangzhou) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion and
Exclusion criteria
to be enrolled in this study: 1. Voluntarily signe the informed consent, could walk freely, understood the study and is willing to follow it, and could complete all test procedures as planned; 2. Body mass index (BMI) : 18.0-30.0 kg/m2 (inclusive), weight ≥45 kg, BMI= weight (kg)/height 2 (m2); 3. 45-70 years old (inclusive) postmenopausal women who have been in post-menopause for 2 years or more. Menopause is defined as: 1) no spontaneous vaginal bleeding or bleeding for more than 12 months; 2) More than 1 year after bilateral oophorectomy (time for unilateral oophorectomy is calculated according to natural menopause); 3) Hysterectomy: more than 50 years old, serum FSH level & GT; 40 iu/L. 50-75 years old (inclusive) men. Male subjects should agree to use effective, investigator-approved contraceptive methods from the time they sign the informed consent until 3 months after administration. 4. BMD T score at lumbar vertebra L1-L4, total hip or femoral neck \< -1.0; 5. Subjects had at least two consecutive vertebrae in L1-L4 and at least one hip bone available for dual-energy DXA bone mineral density assessment; 6. Prior to enrollment, the investigator assessed the subjects to have no medical conditions that would significantly affect the study or may increase additional health risks by asking for medical history, physical examination, and supplementary examination. If the subjects have abnormal examination reports, they can only be enrolled if the investigator evaluates that they do not pose a safety risk to the subjects or do not interfere with the safety evaluation of the clinical study, and explains the reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event | Adverse events were collected from the time informed consent was signed until 12 weeks after the end of treatment | An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 2 hours before treatment and 12 weeks after treatment. | Maximum Observed Concentration of TST002 |
| T1/2 | 2 hours before treatment and 12 weeks after treatment. | Half-life Associated With the Terminal Phase of Elimination for TST002 |
| P1NP | 2 hours before treatment and days 8,29,43,57 and 85 | Percent Change From Baseline in Procollagen TYpe 1 N-terminal Propeptide |
| Tmax | 2 hours before treatment and 12 weeks after treatment | Time to Maximum Observed Concentration of TST002. |
| Immunogenicity | 2 hours before treatment and days 15,29 and 85 | Positive rate and timing of anti-TST002 antibody and neutralizing antibody |
| Serum total osteostatin | 2 hours before treatment and 12 weeks after treatment | Percent change from baseline in serum total sclerostin |
| CL | 2 hours before treatment and 12 weeks after treatment | System clearance rate of TST002 |
| BDM | baseline and day 85 | Percent change from baseline in Bone Mineral Density at L1-L4,total hip and femoral neck |
Countries
China
Contacts
Primary ContactMicheal Shi
Outcome results
None listed