- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05166837
The Safety of STSA-1002 Following Intravenous Infusion in Healthy Subjects
December 19, 2023 updated by: Staidson (Beijing) Biopharmaceuticals Co., Ltd
A Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Phase Ⅰa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002Following Intravenous Infusion in Healthy Subjects
A randomized, double-blind, placebo-controlled, single-ascending dose Phase Ⅰa study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of STSA-1002 following intravenous infusion in healthy subjects
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
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: Jamie Zhang
- Phone Number: +86 15811549898
- Email: zhangjingmei@staidson.com
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230601
- The Second Hospital Of Anhui Medical University
-
-
Beijing
-
Beijing, Beijing, China, 102600
- Peking University People's Hospital
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510799
- The fifth affiliated hosipital of Guangzhou medical university
-
Shenzhen, Guangdong, China, 518036
- Peking University Shenzhen Hospital
-
-
Guizhou
-
Guiyang, Guizhou, China, 550004
- The Affiliated Hospital Of Guizhou Medical University
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy subjects, aged ≥ 18 but ≤ 65, male and female;
- Body mass index: 18.0 -25.0 kg/m2, inclusive;
- Subjects (including their partners) agree to take highly effective contraceptive measures during the study, and they have no birth plan or sperm donation plan within 5 months after the end of the study;
- Medical histories, physical examinations, laboratory examinations and study-related examinations and tests of the subjects show normal results or mild abnormalities with no clinical significance before enrollment, and the Investigator judges that they are eligible;
- Subjects are aware of the risks of the study, and voluntarily participate in the clinical study and sign an informed consent form (ICF).
Exclusion Criteria:
- Past history of tuberculosis, history of contact with active tuberculosis, and positive tuberculin test results;
- History of cardiovascular, respiratory, kidney, liver, metabolism, endocrine, gastrointestinal, blood, nerve, skin and mental illness, cancer or other major disease that in the judgment of the Investigator might put the subject as risk on this study;
- There is a clear history of food or drug allergy or the total serum immunoglobulin IgE is higher than the upper limit of normal;
- Positive screening test results for human immunodeficiency virus (HIV-1/HIV-2) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb);
- Presence of clinically significant vital signs values or of electrocardiogram (ECG) abnormalities during the screening period, as defined by an Investigator;
- ANA positive;
- During the screening period, the white blood cell count and C-reactive protein test results are abnormal and have clinical significance, hemoglobin: male <120g/L or female <110g/L;
- Smoking more than 5 cigarettes per day or equivalent amount of tobacco in the 3 months before screening;
- Subjects whose daily consumption of alcohol at the time of screening or at any time within the prior 6 months is more than 2 standard drinks, where 1 standard drink = 355 mL or 12 oz (1 can) of regular-strength (5%) beer; 150 mL or 5 oz wine; 45 mL or 1.5 oz liquor/spirits (40%);
- Subjects who had a history of drug abuse or tested positive for drugs within 1 year before screening;
- Subjects who have donated either more than approximately 500 mL of blood (exclusive plasma donation) within 3 mooth prior to screening or any plasma within 4 weeks prior to screening;
- Participate in any drug or vaccine clinical trial as a subject within 3 months before screening or prepare to be vaccinated during the study period to 2 months after the end of the study;
- Have taken drugs that may affect immune function within 6 months before screening or have received any monoclonal antibody or biological agent treatment within the previous 3 months and have taken prescription/over-the-counter drugs, herbal medicines, vitamins or other supplements within the previous 14 days;
- Drink more than 5 cups of coffee, tea or cola per day (150ml and above per cup);
- Women who are pregnant or breastfeeding;
- People with a history of fainting, bleeding and needles;
- The investigator believes that there are any subjects who are not suitable to participate in this trial.
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: Cohort 1:2mg/kg
All participants (fasted) received either 2 mg/kg of STSA-1002 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenous injection
|
Experimental: Cohort 2:5mg/kg
All participants (fasted) received either 5 mg/kg of STSA-1002 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenous injection
|
Experimental: Cohort 3:10mg/kg
All participants (fasted) received either 10 mg/kg of STSA-1002 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenous injection
|
Experimental: Cohort 4:20mg/kg
All participants (fasted) received either 20 mg/kg of STSA-1002 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenous injection
|
Experimental: Cohort 5:30mg/kg
All participants (fasted) received either 30 mg/kg of STSA-1002 as a single dose or dose-matched placebo.
|
Intravenous injection
Intravenous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities.
Time Frame: 48 days
|
48 days
|
|
Maximum plasma concentration (Cmax)
Time Frame: Up to 1152 hours postdose
|
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
|
Up to 1152 hours postdose
|
Area under the plasma concentration-time curve from time 0 to the collection time point t of the last measurable concentration (AUC0-t)
Time Frame: Up to 1152 hours postdose
|
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
|
Up to 1152 hours postdose
|
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
Time Frame: Up to 1152 hours postdose
|
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
|
Up to 1152 hours postdose
|
Time of maximum concentration (Tmax)
Time Frame: Up to 1152 hours postdose
|
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
|
Up to 1152 hours postdose
|
Elimination half-life (t1/2)
Time Frame: Up to 1152 hours postdose
|
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
|
Up to 1152 hours postdose
|
Elimination rate constant of plasma drug concentration in terminal phase (λz)
Time Frame: Up to 1152 hours postdose
|
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
|
Up to 1152 hours postdose
|
Last measurable concentration (Clast)
Time Frame: Up to 1152 hours postdose
|
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
|
Up to 1152 hours postdose
|
Mean residence time (MRT)
Time Frame: Up to 1152 hours postdose
|
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
|
Up to 1152 hours postdose
|
Clearance (CL)
Time Frame: Up to 1152 hours postdose
|
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
|
Up to 1152 hours postdose
|
Apparent volume of distribution (Vz)
Time Frame: Up to 1152 hours postdose
|
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
|
Up to 1152 hours postdose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in concentration of free C5a and anti-drug antibody
Time Frame: Up to 1152 hours postdose
|
To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 in healthy subjects
|
Up to 1152 hours postdose
|
Change from baseline in concentration of CH50, IL-6, IL-8,C4, TNF-α, IFN-γ
Time Frame: Up to 1152 hours postdose
|
To evaluate the effect of STSA-1002 on CH50, IL-6, IL-8, C4,TNF-α, IFN-γ
|
Up to 1152 hours postdose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 10, 2022
Primary Completion (Actual)
January 12, 2023
Study Completion (Actual)
January 12, 2023
Study Registration Dates
First Submitted
December 8, 2021
First Submitted That Met QC Criteria
December 8, 2021
First Posted (Actual)
December 22, 2021
Study Record Updates
Last Update Posted (Estimated)
December 20, 2023
Last Update Submitted That Met QC Criteria
December 19, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- STSA-1002-02
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.
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