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OsteoporosisPhase 1NCT05391776

TST002 Intervenous Injection in Postmenopausal Women and Men With Reduced Bone Mineral Density

A Phase 1 study testing TST002 Injection in people with Osteoporosis, run by HJB (Hangzhou) Co., Ltd. at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Osteoporosis
What is being tested?
TST002 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
5 sitesChina
Study dates
28 Apr 2022to 28 Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 \&lt; 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

Micheal Shi contact

860512-67079200

micheal.shi@transcenta.com

5 sites in 1 country

China5 sites, 5 recruiting

  • West China Hospital，Sichuan University

    Chengdu, Sichuan, 610044

    Decai Chen, 18980601309, 18980601309@163.com

    Not yet recruiting

  • West China Hospital，Sichuan University

    Chengdu, Sichuan

    Ping Feng, 028-85423583, 617130961@qq.com

    Not yet recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471000

    Liping Li, 13700814316, llp1203@163.com

    Not yet recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

    Hua Lin, 02583106666, Lh2116@126.com

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

    Juan Li, 025-83106666, Juanli2003@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Osteoporosis
Being tested
TST002 Injection, placebo
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TST002 InjectionDrug

    Also called TST002-IgG4

    This single dose study, ascending with phase I dose-escalation principles from 200mg up to 1200mg.

  • placeboDrug

    This single dose study, ascending with phase I dose-escalation principles from 200mg up to 1200mg.

Study groups in NCT05391776
Study groupRoleWhat they receive
A single ascending dose of TST002 Intervenous InjectionExperimentalFour 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.
Receives: Drug: TST002 Injection
A single ascending dose of placebo Intervenous InjectionPlacebo comparatorFour 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.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Adverse events were collected from the time informed consent was signed until 12 weeks after the end of treatment

Secondary outcomes (8)

  1. Tmax

    Time to Maximum Observed Concentration of TST002.

    Measured: 2 hours before treatment and 12 weeks after treatment

  2. Cmax

    Maximum Observed Concentration of TST002

    Measured: 2 hours before treatment and 12 weeks after treatment.

  3. T1/2

    Half-life Associated With the Terminal Phase of Elimination for TST002

    Measured: 2 hours before treatment and 12 weeks after treatment.

  4. P1NP

    Percent Change From Baseline in Procollagen TYpe 1 N-terminal Propeptide

    Measured: 2 hours before treatment and days 8,29,43,57 and 85

  5. BDM

    Percent change from baseline in Bone Mineral Density at L1-L4,total hip and femoral neck

    Measured: baseline and day 85

  6. Immunogenicity

    Positive rate and timing of anti-TST002 antibody and neutralizing antibody

    Measured: 2 hours before treatment and days 15,29 and 85

  7. Serum total osteostatin

    Percent change from baseline in serum total sclerostin

    Measured: 2 hours before treatment and 12 weeks after treatment

  8. CL

    System clearance rate of TST002

    Measured: 2 hours before treatment and 12 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2022
  2. Study start28 Apr 2022
  3. Primary completion28 Apr 2023 (estimated)
  4. Study completion28 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05391776
Sponsor's protocol ID
TST002-1001
Status last verified
May 2022
First submitted
16 May 2022
Last updated
26 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhou S, Zhu X, Sheng Y, Wang L, Shao F, Lin H. Safety, pharmacokinetics, pharmacodynamics and target-mediated drug disposition modeling of TST002, a sclerostin antibody, in men and postmenopausal women with low bone mineral density. Expert Opin Investig Drugs. 2026 Sep 16. doi: 10.1080/13543784.2026.2736007. Online ahead of print.

    PubMed 42747328

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TST002 Injection in people with Osteoporosis, run by HJB (Hangzhou) Co., Ltd. at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Micheal Shi (860512-67079200, micheal.shi@transcenta.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event (time frame: Adverse events were collected from the time informed consent was signed until 12 weeks after the end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05391776, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.

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