- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05391776
TST002 Intervenous Injection in Postmenopausal Women and Men With Reduced Bone Mineral Density
May 20, 2022 updated by: HJB (Hangzhou) Co., Ltd.
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TST002 Intervenous Injection in Postmenopausal Women and Men With Reduced Bone Mineral Density
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Micheal Shi
- Phone Number: 860512-67079200
- Email: micheal.shi@transcenta.com
Study Locations
-
-
Henan
-
Luoyang, Henan, China, 471000
- Not yet recruiting
- The First Affiliated Hospital of Henan University of Science and Technology
-
Contact:
- Liping Li
- Phone Number: 13700814316
- Email: llp1203@163.com
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210008
- Recruiting
- Nanjing Drum Tower hospital
-
Contact:
- Hua Lin
- Phone Number: 02583106666
- Email: Lh2116@126.com
-
Nanjing, Jiangsu, China
- Recruiting
- Nanjing Drum Tower hospital
-
Contact:
- Juan Li
- Phone Number: 025-83106666
- Email: Juanli2003@163.com
-
-
Sichuan
-
Chengdu, Sichuan, China
- Not yet recruiting
- West China Hospital,Sichuan University
-
Contact:
- Ping Feng
- Phone Number: 028-85423583
- Email: 617130961@qq.com
-
Chengdu, Sichuan, China, 610044
- Not yet recruiting
- West China Hospital,Sichuan University
-
Contact:
- Decai Chen
- Phone Number: 18980601309
- Email: 18980601309@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Subjects must meet all of the following inclusion and exclusion criteria to be enrolled in this study:
- 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;
- Body mass index (BMI) : 18.0-30.0 kg/m2 (inclusive), weight ≥45 kg, BMI= weight (kg)/height 2 (m2);
- 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.
- BMD T score at lumbar vertebra L1-L4, total hip or femoral neck < -1.0;
- 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;
- 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.
Exclusion Criteria:
- Blood donation or bleeding of 400mL or more within 3 months before screening; History of blood transfusion within 3 months prior to screening;
- People who have a history of drug allergy or allergic constitution;
- Received systemic glucocorticoid treatment 3 months before screening, and took prednisone equivalent of more than 5mg per day for a total of more than 10 days; Inhalation or topical administration within 2 weeks prior to screening is not included;
Have a history of alcohol or drug abuse or tobacco abuse in the past year (smoking more than 5 cigarettes per day).
Note: Criteria for alcohol intake: weekly alcohol intake < 14 units/week, 1 unit =360 mL beer; Or 150 mL wine; Or 45 mL white wine;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is greater than 1.25 times the upper limit of normal value or total bilirubin is greater than 1.1 times the upper limit of normal value; Renal function laboratory examination is judged to be clinically significant by researchers.
- History of breast cancer (female subjects only); Hereditary family history of breast cancer or known BRCA1/2 gene mutation; Mammography within 6 months prior to screening does not exclude breast cancer.
- Have a history of thrombocytopenia, or have a platelet count below the lower limit of the normal range during screening;
- It is clinically significant to have previous diseases or hemorrhagic diseases leading to coagulation abnormalities or coagulation abnormalities during screening period;
- Those who had a serious injury or major surgical operation within 1 month prior to the screening period, or who planned to have surgery during the study period;
- History of solid organ and bone marrow transplants;
- Participated in any clinical trials within 3 months prior to screening.
- Other conditions that, in the investigator's judgment, are unsuitable for study participation, such as factors that, in the investigator's judgment, pose a risk to the safety of the subject or interfere with the study evaluation, procedure, or completion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A single ascending dose of TST002 Intervenous Injection
Four single dose cohorts are designed in this study, 8 subjects will be enrolled in each cohort, Subjects in each dose group were randomized to receive TST002 or placebo in a ratio of 3:1.
|
This single dose study, ascending with phase I dose-escalation principles from 200mg up to 1200mg.
Other Names:
|
Placebo Comparator: A single ascending dose of placebo Intervenous Injection
Four single dose cohorts are designed in this study, 8 subjects will be enrolled in each cohort, Subjects in each dose group were randomized to receive TST002 or placebo in a ratio of 3:1.
|
This single dose study, ascending with phase I dose-escalation principles from 200mg up to 1200mg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Event
Time Frame: 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.
|
Adverse events were collected from the time informed consent was signed until 12 weeks after the end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax
Time Frame: 2 hours before treatment and 12 weeks after treatment
|
Time to Maximum Observed Concentration of TST002.
|
2 hours before treatment and 12 weeks after treatment
|
Cmax
Time Frame: 2 hours before treatment and 12 weeks after treatment.
|
Maximum Observed Concentration of TST002
|
2 hours before treatment and 12 weeks after treatment.
|
T1/2
Time Frame: 2 hours before treatment and 12 weeks after treatment.
|
Half-life Associated With the Terminal Phase of Elimination for TST002
|
2 hours before treatment and 12 weeks after treatment.
|
P1NP
Time Frame: 2 hours before treatment and days 8,29,43,57 and 85
|
Percent Change From Baseline in Procollagen TYpe 1 N-terminal Propeptide
|
2 hours before treatment and days 8,29,43,57 and 85
|
BDM
Time Frame: baseline and day 85
|
Percent change from baseline in Bone Mineral Density at L1-L4,total hip and femoral neck
|
baseline and day 85
|
Immunogenicity
Time Frame: 2 hours before treatment and days 15,29 and 85
|
Positive rate and timing of anti-TST002 antibody and neutralizing antibody
|
2 hours before treatment and days 15,29 and 85
|
Serum total osteostatin
Time Frame: 2 hours before treatment and 12 weeks after treatment
|
Percent change from baseline in serum total sclerostin
|
2 hours before treatment and 12 weeks after treatment
|
CL
Time Frame: 2 hours before treatment and 12 weeks after treatment
|
System clearance rate of TST002
|
2 hours before treatment and 12 weeks after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 28, 2022
Primary Completion (Anticipated)
April 28, 2023
Study Completion (Anticipated)
June 28, 2023
Study Registration Dates
First Submitted
May 16, 2022
First Submitted That Met QC Criteria
May 20, 2022
First Posted (Actual)
May 26, 2022
Study Record Updates
Last Update Posted (Actual)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 20, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TST002-1001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoporosis
-
Radius Health, Inc.CompletedOsteoporosis | Osteoporosis Risk | Osteoporosis, Postmenopausal | Osteoporosis Fracture | Osteoporosis, Age-Related | Osteoporosis Localized to Spine | Osteoporosis Senile | Osteoporosis of Vertebrae | Osteoporosis VertebralUnited States
-
Radius Health, Inc.CompletedOsteoporosis | Age Related Osteoporosis | Osteoporosis, Age-Related | Osteoporosis Localized to Spine | Osteoporosis Senile | Osteoporosis of VertebraeUnited States, Poland, Italy
-
Hoffmann-La RocheCompletedPostmenopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States, Puerto Rico
-
Centre Hospitalier Universitaire de Saint EtienneMinistry of Health, FranceRecruitingPost Menopausal OsteoporosisFrance
-
AmgenCompletedPost Menopausal OsteoporosisFrance
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisSpain, South Africa, Germany, Mexico, United States, Canada, France, United Kingdom, Italy, Belgium, Australia, Poland, Denmark, Hungary, Czech Republic, Norway
-
Hoffmann-La RocheGlaxoSmithKlineCompletedPost Menopausal OsteoporosisFrance
-
Novartis PharmaceuticalsCompletedPost-menopausal OsteoporosisColombia, Belgium, Sweden, Hong Kong, United States, Hungary, Switzerland, Australia, Germany, Italy, Canada, Poland, Argentina, Thailand, Norway, New Zealand, France, Finland
Clinical Trials on TST002 Injection
-
National Taiwan University HospitalRecruitingOsteoarthritis (OA) of the KneeTaiwan
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Enrolling by invitationAdvanced Malignant TumorsChina
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruiting
-
Shengjing HospitalJiangsu HengRui Medicine Co., Ltd.Not yet recruitingER Positive/HER2 Low Breast CancerChina
-
Dalia Salah SaifUnknownRA - Rheumatoid ArthritisEgypt
-
Royan InstituteCompletedMyocardial InfarctionIran, Islamic Republic of
-
United States Naval Medical Center, San DiegoCEL-SCI CorporationTerminated
-
National Taiwan University HospitalCompleted