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

NCT05559125 | Terminated Phase 1

• 1 other identifier: STSA-1002/1005-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.

  To evaluate the safety and tolerability of single intravenous administration of STSA-1002 combined with STSA-1005 in healthy adult subjects.

  56 days

Secondary Outcomes (12)

• Maximum plasma concentration (Cmax).

  Up to 1344hours postdose

• Area under the plasma concentration-time curve from time 0 to the collection time point t of the last measurable concentration (AUC0-t).

  Up to 1344 hours postdose

• Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).

  Up to 1344 hours postdose

• Time of maximum concentration (Tmax)

  Up to 1344hours postdose

• Elimination half-life (t1/2).

  Up to 1344 hours postdose

Study Arms (4)

STSA-1002 and STSA-1005 dose level 1

EXPERIMENTAL

Drug: STSA-1002 Injection; Drug: STSA-1005 Injection

STSA-1002 and STSA-1005 dose level 2

EXPERIMENTAL

Drug: STSA-1002 Injection; Drug: STSA-1005 Injection

STSA-1002 and STSA-1005 dose level 3

EXPERIMENTAL

Drug: STSA-1002 Injection; Drug: STSA-1005 Injection

STSA-1002 and STSA-1005 dose level 4

EXPERIMENTAL

Drug: STSA-1002 Injection; Drug: STSA-1005 Injection

Interventions

STSA-1002 Injection DRUG

Intravenous injection

STSA-1002 and STSA-1005 dose level 1; STSA-1002 and STSA-1005 dose level 2; STSA-1002 and STSA-1005 dose level 3; STSA-1002 and STSA-1005 dose level 4

STSA-1005 Injection DRUG

Intravenous injection

STSA-1002 and STSA-1005 dose level 1; STSA-1002 and STSA-1005 dose level 2; STSA-1002 and STSA-1005 dose level 3; STSA-1002 and STSA-1005 dose level 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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；

Sponsors & Collaborators

• Staidson (Beijing) Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital Of Xingtai Medical College

Xingtai, Hebei, 054000, China

Location

Study Officials

• Fengxue Guo, Bachelor

  The Second Affiliated Hospital of Xingtai Medical College

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: November 8, 2022
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: May 22, 2024

Record last verified: 2023-12

Locations

CN (1)