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

NCT05391776 | Unknown Phase 1

• 1 other identifier: TST002-1001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

• Tmax

  2 hours before treatment and 12 weeks after treatment

• Cmax

  2 hours before treatment and 12 weeks after treatment.

• T1/2

  2 hours before treatment and 12 weeks after treatment.

• P1NP

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

• BDM

  baseline and day 85

Study Arms (2)

A single ascending dose of TST002 Intervenous Injection

EXPERIMENTAL

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.

Drug: TST002 Injection

A single ascending dose of placebo Intervenous Injection

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

TST002 Injection DRUG

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

Also known as: TST002-IgG4

A single ascending dose of TST002 Intervenous Injection

placebo DRUG

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

A single ascending dose of placebo Intervenous Injection

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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);
• 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.
• 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.
• 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;

Sponsors & Collaborators

• HJB (Hangzhou) Co., Ltd.: lead

Study Sites (5)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471000, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

West China Hospital，Sichuan University

Chengdu, Sichuan, 610044, China

NOT YET RECRUITING

West China Hospital，Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Micheal Shi

CONTACT

860512-67079200; micheal.shi@transcenta.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 26, 2022
• Study Start: April 28, 2022
• Primary Completion: April 28, 2023
• Study Completion: June 28, 2023
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)