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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
This single dose study, ascending with phase I dose-escalation principles from 200mg up to 1200mg.
This single dose study, ascending with phase I dose-escalation principles from 200mg up to 1200mg.
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
NOT_YET_RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Adverse Event
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.
Time frame: Adverse events were collected from the time informed consent was signed until 12 weeks after the end of treatment
Tmax
Time to Maximum Observed Concentration of TST002.
Time frame: 2 hours before treatment and 12 weeks after treatment
Cmax
Maximum Observed Concentration of TST002
Time frame: 2 hours before treatment and 12 weeks after treatment.
T1/2
Half-life Associated With the Terminal Phase of Elimination for TST002
Time frame: 2 hours before treatment and 12 weeks after treatment.
P1NP
Percent Change From Baseline in Procollagen TYpe 1 N-terminal Propeptide
Time frame: 2 hours before treatment and days 8,29,43,57 and 85
BDM
Percent change from baseline in Bone Mineral Density at L1-L4,total hip and femoral neck
Time frame: baseline and day 85
Immunogenicity
Positive rate and timing of anti-TST002 antibody and neutralizing antibody
Time frame: 2 hours before treatment and days 15,29 and 85
Serum total osteostatin
Percent change from baseline in serum total sclerostin
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West China Hospital,Sichuan University
Chengdu, Sichuan, China
NOT_YET_RECRUITINGWest China Hospital,Sichuan University
Chengdu, Sichuan, China
NOT_YET_RECRUITINGTime frame: 2 hours before treatment and 12 weeks after treatment
CL
System clearance rate of TST002
Time frame: 2 hours before treatment and 12 weeks after treatment