HealthyPhase 1NCT05166837
The Safety of STSA-1002 Following Intravenous Infusion in Healthy Subjects
A Phase 1 study testing STSA-1002 injection in people with Healthy, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 5 sites in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- STSA-1002 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 5 sitesChina
- Study dates
- 10 Jan 2022to 12 Jan 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Peking university People's Hospital
Beijing, Beijing Municipality, 102600
The fifth affiliated hosipital of Guangzhou medical university
Guangzhou, Guangdong, 510799
The affiliated hospital of Guizhou medical university
Guiyang, Guizhou, 550004
The second hospital of Anhui medical university
Hefei, Anhui, 230601
Peking university Shenzhen Hospital
Shenzhen, Guangdong, 518036
About this study
Official title: 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
- Conditions
- Healthy
- Being tested
- STSA-1002 injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STSA-1002 injectionDrug
Intravenous injection
PlaceboDrug
Intravenous injection
STSA-1002 injectionDrug
Intravenous injection
PlaceboDrug
Intravenous injection
STSA-1002 injectionDrug
Intravenous injection
PlaceboDrug
Intravenous injection
STSA-1002 injectionDrug
Intravenous injection
PlaceboDrug
Intravenous injection
STSA-1002 injectionDrug
Intravenous injection
PlaceboDrug
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1:2mg/kg | Experimental | All participants (fasted) received either 2 mg/kg of STSA-1002 as a single dose or dose-matched placebo. Receives: Drug: STSA-1002 injection; Drug: Placebo |
| Cohort 2:5mg/kg | Experimental | All participants (fasted) received either 5 mg/kg of STSA-1002 as a single dose or dose-matched placebo. Receives: Drug: STSA-1002 injection; Drug: Placebo |
| Cohort 3:10mg/kg | Experimental | All participants (fasted) received either 10 mg/kg of STSA-1002 as a single dose or dose-matched placebo. Receives: Drug: STSA-1002 injection; Drug: Placebo |
| Cohort 4:20mg/kg | Experimental | All participants (fasted) received either 20 mg/kg of STSA-1002 as a single dose or dose-matched placebo. Receives: Drug: STSA-1002 injection; Drug: Placebo |
| Cohort 5:30mg/kg | Experimental | All participants (fasted) received either 30 mg/kg of STSA-1002 as a single dose or dose-matched placebo. Receives: Drug: STSA-1002 injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities.
Measured: 48 days
Maximum plasma concentration (Cmax)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Measured: 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)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Measured: Up to 1152 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Measured: Up to 1152 hours postdose
Time of maximum concentration (Tmax)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Measured: Up to 1152 hours postdose
Elimination half-life (t1/2)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Measured: Up to 1152 hours postdose
Elimination rate constant of plasma drug concentration in terminal phase (λz)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Measured: Up to 1152 hours postdose
Last measurable concentration (Clast)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Measured: Up to 1152 hours postdose
Mean residence time (MRT)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Measured: Up to 1152 hours postdose
Clearance (CL)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Measured: Up to 1152 hours postdose
Apparent volume of distribution (Vz)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Measured: Up to 1152 hours postdose
Secondary outcomes (2)
Change from baseline in concentration of free C5a and anti-drug antibody
To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 in healthy subjects
Measured: Up to 1152 hours postdose
Change from baseline in concentration of CH50, IL-6, IL-8,C4, TNF-α, IFN-γ
To evaluate the effect of STSA-1002 on CH50, IL-6, IL-8, C4,TNF-α, IFN-γ
Measured: Up to 1152 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start10 Jan 2022
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166837
- Sponsor's protocol ID
- STSA-1002-02
- Status last verified
- Apr 2023
- First submitted
- 8 Dec 2021
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05166837
- Acronym / sponsor ID
- STSA-1002-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1:2mg/kg | Experimental | Drug: STSA-1002 injection, Drug: PlaceboAll participants (fasted) received either 2 mg/kg of STSA-1002 as a single dose or dose-matched placebo. |
| Cohort 2:5mg/kg | Experimental | Drug: STSA-1002 injection, Drug: PlaceboAll participants (fasted) received either 5 mg/kg of STSA-1002 as a single dose or dose-matched placebo. |
| Cohort 3:10mg/kg | Experimental | Drug: STSA-1002 injection, Drug: PlaceboAll participants (fasted) received either 10 mg/kg of STSA-1002 as a single dose or dose-matched placebo. |
| Cohort 4:20mg/kg | Experimental | Drug: STSA-1002 injection, Drug: PlaceboAll participants (fasted) received either 20 mg/kg of STSA-1002 as a single dose or dose-matched placebo. |
| Cohort 5:30mg/kg | Experimental | Drug: STSA-1002 injection, Drug: PlaceboAll participants (fasted) received either 30 mg/kg of STSA-1002 as a single dose or dose-matched placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STSA-1002 injectionIntravenous injection | Drug | Cohort 1:2mg/kg |
| PlaceboIntravenous injection | Drug | Cohort 1:2mg/kg |
| STSA-1002 injectionIntravenous injection | Drug | Cohort 2:5mg/kg |
| PlaceboIntravenous injection | Drug | Cohort 2:5mg/kg |
| STSA-1002 injectionIntravenous injection | Drug | Cohort 3:10mg/kg |
| PlaceboIntravenous injection | Drug | Cohort 3:10mg/kg |
| STSA-1002 injectionIntravenous injection | Drug | Cohort 4:20mg/kg |
| PlaceboIntravenous injection | Drug | Cohort 4:20mg/kg |
| STSA-1002 injectionIntravenous injection | Drug | Cohort 5:30mg/kg |
| PlaceboIntravenous injection | Drug | Cohort 5:30mg/kg |
Primary outcome
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
Maximum plasma concentration (Cmax)
Time frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
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
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
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
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
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
Last measurable concentration (Clast)
Time frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Mean residence time (MRT)
Time frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Clearance (CL)
Time frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
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
2 secondary outcomes
Change from baseline in concentration of free C5a and anti-drug antibody
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STSA-1002 injection in people with Healthy, run by Staidson (Beijing) Biopharmaceuticals 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 20 Dec 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2023.