A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects

NCT ID: NCT05559125

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-08
• Study Completion Date: 2024-03-26

Brief Summary

An open-label, single-ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of STSA-1002 combined with STSA-1005 in healthy subjects.

Conditions

Healthy Subject

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

STSA-1002 and STSA-1005 dose level 1

Group Type: EXPERIMENTAL

STSA-1002 Injection

Intervention Type: DRUG

Intravenous injection

STSA-1005 Injection

Intervention Type: DRUG

Intravenous injection

STSA-1002 and STSA-1005 dose level 2

Group Type: EXPERIMENTAL

STSA-1002 Injection

Intervention Type: DRUG

Intravenous injection

STSA-1005 Injection

Intervention Type: DRUG

Intravenous injection

STSA-1002 and STSA-1005 dose level 3

Group Type: EXPERIMENTAL

STSA-1002 Injection

Intervention Type: DRUG

Intravenous injection

STSA-1005 Injection

Intervention Type: DRUG

Intravenous injection

STSA-1002 and STSA-1005 dose level 4

Group Type: EXPERIMENTAL

STSA-1002 Injection

Intervention Type: DRUG

Intravenous injection

STSA-1005 Injection

Intervention Type: DRUG

Intravenous injection

Interventions

STSA-1002 Injection

Intravenous injection

Intervention Type: DRUG

STSA-1005 Injection

Intravenous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy subjects, aged ≥ 18 but ≤ 45, male and female;
• Weight: Male≥50.0kg, Female ≥ 45kg; Body mass index: 19.0-26.0 kg/m2, inclusive;
• Subjects (including their partners) must take effective contraceptive measures and have no birth plan or sperm or egg donation plan during the trial period and within 6 months after the end of the last administration;
• The subjects were aware of the risks of the trial, voluntarily participated in the study and signed the informed consent form (ICF).

Exclusion Criteria

• Have a history of serious disease (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular diseases) or have undergone any major surgery within 2 months prior to screening;
• The investigators determined that abnormalities in pre-enrollment physical examinations, laboratory tests, and trial-related tests were clinically significant;
• A definite history of food or drug allergies;
• Positive screening test results for human immunodeficiency virus (HIV) antibodies, syphilis-specific antibody, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb);
• History of tuberculosis; or combined with T-SPOT.TB results, low-dose chest CT comprehensive evaluation of tuberculosis infection;
• Hemoglobin was lower than the lower limit of normal value during the screening period;
• Smoking more than 5 or equivalent cigarettes per day in the 3 months before screening;
• Regular drinkers in the 6 months prior to screening, i.e. those who have consumed more than 2 units of alcohol per day (1 unit =360ml beer or 45ml spirits with an alcohol concentration of 40% or 150ml wine) in the 6 months prior to screening or have a positive alcohol test result;
• Subjects with a history of substance abuse within 1 year before screening or have a positive drug test result;
• Blood loss or blood donation > 400ml three months before screening, or blood transfusion history within 4 weeks before inclusion;
• Participate in clinical trials of new drugs or vaccines as a subject within 3 months prior to screening；
• Vaccination was given within 1 month before screening or planned between the study period and 2 months after the end of the study;
• Use of medications that may affect immune function in the 6 months prior to screening or any monoclonal antibody or biologic treatment in the 3 months prior to screening and use of prescription drugs/over-the-counter drugs or herbal medicines in the 14 days prior to screening；
• Drink more than 5 cups of coffee, tea or cola (150ml or more per cup) daily within 3 months before screening;
• Pregnant or lactating women;
• A history of blood and needle sickness；
• Other circumstances in which the investigator considers it inappropriate to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Staidson (Beijing) Biopharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fengxue Guo, Bachelor

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Xingtai Medical College

Locations

The Second Affiliated Hospital Of Xingtai Medical College

Xingtai, Hebei, China

Countries

China

Other Identifiers

STSA-1002/1005-01

Identifier Type: -

Identifier Source: org_study_id