Primary Immune ThrombocytopeniaPhase 1NCT06148389
The Safety and Tolerability of STSA-1301 Subcutaneous Injection in Healthy Subjects
A Phase 1 study testing STSA-1301 subcutaneous injection in people with Primary Immune Thrombocytopenia, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
A randomized, double-blind, placebo-controlled, single-ascending dose, phase Ia study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamics, and immunogenicity of STSA-1301 Subcutaneous Injection 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
- Primary Immune Thrombocytopenia
- What is being tested?
- STSA-1301 subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2023to 3 Apr 2024
- 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, male and female, aged between 18 and 65 years, inclusive;
- Body mass index: 18.0～28.0 kg/m2, inclusive; weight ≥50 kg for males and ≥45kg for females at enrollment;
- 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 3 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
- Pregnant or lactating women;
- 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.
- After splenectomy or any major surgery within 6 months prior to screening;
- Subjects have an active infection or have a serious infection (leading to hospitalization or requiring parenteral antibiotic therapy) within 6 weeks prior to the first dose; subjects with clinically active or chronic uncontrolled bacterial, viral or fungal infections at screening;
- Total IgG was less than the lower limit of normal at screening. Subjects with absolute neutrophil count <1.5X109/L and/or absolute lymphocyte count <1.0X109/L;
- Subjects have a history of malignancy;
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- Subjects who are allergic to this product or any of its ingredients, history of eczema, asthma or other allergic diseases;
- Subjects are TIGRA (T cell interferon gamma release assay) positive at screening. If TIGRA is not available, a PPD skin test may be used instead and chest imaging performed at screening showing evidence of latent/active tuberculosis (TB);
- Positive screening test results for human immunodeficiency virus (HIV) antibodies, syphilis specific antibody, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (Anti-HCV);
- Presence of electrocardiogram (ECG) abnormalities during the screening period, as defined by an Investigator;
- Subjects have any conditions affecting blood collection;
- Subjects whose daily consumption of coffee, tea and/or cola is more than 750 mL in the last 3 months before enrollment;
- Subject who have nicotine consumption more than 5 cigarettes or the equivalent amount of tobacco per day within 3 months prior to 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 = 360 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%); abnormal alcohol test results at screening or baseline;
- History of drug abuse within 1 year prior to screening; subjects with a positive urine drug abuse screen at screening or baseline;
- Blood loss or donation>400mL within 3 months prior to screening or history of transfusion or use of any blood products within 3 months prior to enrollment;
- Participation as a subject in any drug or vaccine or medical device clinical trial within 3 months prior to screening;
- Vaccination or planned vaccination within 4 weeks prior to screening to 3 months after end of dosing;
- Subjects who have taken drugs that may affect immune function within 6 months before screening, have received any monoclonal antibody or biological agent for treatment within the previous 3 months, and have previous treatment with any prescribed medications, over-the-counter (OTC) medications, herbal medicines or other supplements within 14 days prior to screening;
- Subjects with any factors that would, in the Investigator's judgment, preclude them from participating in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Ditan Hospital,Capital Medical University
Beijing, Chaoyang District, 100015
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-ascending Dose, Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics, and Immunogenicity of STSA-1301 Subcutaneous Injection in Healthy Subjects
A randomized, double-blind, placebo-controlled, single-ascending dose, phase Ia study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamics, and immunogenicity of STSA-1301 Subcutaneous Injection in healthy subjects.
- Conditions
- Primary Immune Thrombocytopenia
- Being tested
- STSA-1301 subcutaneous injection, Placebo
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STSA-1301 subcutaneous injectionDrug
Subjects will receive the administration dose on Day 0 following protocol requirements.
PlaceboDrug
Subjects will receive the administration dose on Day 0 following protocol requirements.
| Study group | Role | What they receive |
|---|---|---|
| lowest dose group | Experimental | 4 subjects will be randomized to receive lowest dose of STSA-1301 subcutaneous injection or dose-matched placebo (First cohort) Receives: Drug: STSA-1301 subcutaneous injection; Drug: Placebo |
| low dose group | Experimental | 8 subjects will be randomized to receive low dose of STSA-1301 subcutaneous injection or dose-matched placebo (Second cohort) Receives: Drug: STSA-1301 subcutaneous injection; Drug: Placebo |
| middle dose group | Experimental | 8 subjects will be randomized to receive middle dose of STSA-1301 subcutaneous injection or dose-matched placebo (Third cohort) Receives: Drug: STSA-1301 subcutaneous injection; Drug: Placebo |
| high dose group | Experimental | 8 subjects will be randomized to receive high dose of STSA-1301 subcutaneous injection or dose-matched placebo (Fourth cohort) Receives: Drug: STSA-1301 subcutaneous injection; Drug: Placebo |
| highest dose group | Experimental | 8 subjects will be randomized to receive highest dose of STSA-1301 subcutaneous injection or dose-matched placebo (Fifth cohort) Receives: Drug: STSA-1301 subcutaneous injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-related adverse events as assessed by CTCAE 5.0.
To evaluate the safety and tolerability of STSA-1301 subcutaneous injection in healthy adult subjects.
Measured: 50 days
Safety as measured by subject incidence of treatment-emergent clinically significant changes in clinical laboratory safety tests.
Subject incidence of treatment-emergent clinically significant changes in clinical laboratory safety tests (Complete Blood Count (absolute counts and %), Fasting blood glucose concentration, Serum concentrations in Electrolytes, Protein, Albumin, Total Bilirubin, Blood urea nitrogen, Creatinine, Aspartate Aminotransferase, Alanine Aminotransferase, estimated Glomerular Filtration Rate (eGFR), Activated partial thromboplastin time (aPTT), Prothrombin Time test (PT) with International Normalized Ratio (INR) and Urinalysis safety tests (pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, and leukocyte esterase)).
Measured: 50 days
Safety as measured by subject incidence of treatment-emergent clinically significant changes in vital signs.
Subject incidence of treatment-emergent clinically significant changes in vital signs (Systolic and Diastolic Blood Pressure in millimeters of mercury (mmHg), Pulse Rate in beats per minute (bpm), Respiratory Rate in beats per minute (bpm) and Body temperature in Celsius).
Measured: 50 days
Safety as measured by subject incidence of treatment-emergent clinically significant changes in physical examination.
Subject incidence of treatment-emergent clinically significant changes in physical examination (Skin mucosa, lymph nodes, head and neck, chest, abdomen, musculoskeletal, nervous system).
Measured: 50 days
Safety as measured by subject incidence of treatment-emergent clinically significant changes in Electrocardiogram (ECG).
Subject incidence of treatment-emergent clinically significant changes in 12-lead ECGs (Heart Rate in beats per minute (bpm), PR interval in milliseconds (msec), QRS duration in milliseconds (msec), QTc in milliseconds (msec), QT interval in milliseconds (msec)).
Measured: 50 days
Maximum plasma concentration (Cmax)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Measured: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
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-1301
Measured: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Measured: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
Time of maximum concentration (Tmax)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Measured: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
Elimination half-life (t1/2)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Measured: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
Elimination rate constant of plasma drug concentration in terminal phase (λz)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Measured: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
Last measurable concentration (Clast)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Measured: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
Mean residence time (MRT)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Measured: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
Clearance (CL)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Measured: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
Apparent volume of distribution (Vz)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Measured: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
Secondary outcomes (2)
Change from baseline in concentration of IgG.
To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1301 subcutaneous injection in healthy adult subjects.
Measured: Pre-dose; after dose 8 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days, 28 days and 49 days
Change from baseline in concentration of anti-drug antibody
To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1301 subcutaneous injection in healthy adult subjects.
Measured: Pre-dose; after dose 14 days, 28 days, 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start16 Nov 2023
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune ThrombocytopeniaStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronghua Jin, Doctor, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148389
- Sponsor's protocol ID
- STSA-1301-01
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. 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, Pharmacokinetic, Pharmacodynamics, and Immunogenicity of STSA-1301 Subcutaneous Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06148389
- Acronym / sponsor ID
- STSA-1301-01
- Conditions
- Primary Immune Thrombocytopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 28 Nov 2023 (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, pharmacokinetic, pharmacodynamics, and immunogenicity of STSA-1301 Subcutaneous Injection in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| lowest dose group | Experimental | Drug: STSA-1301 subcutaneous injection, Drug: Placebo4 subjects will be randomized to receive lowest dose of STSA-1301 subcutaneous injection or dose-matched placebo (First cohort) |
| low dose group | Experimental | Drug: STSA-1301 subcutaneous injection, Drug: Placebo8 subjects will be randomized to receive low dose of STSA-1301 subcutaneous injection or dose-matched placebo (Second cohort) |
| middle dose group | Experimental | Drug: STSA-1301 subcutaneous injection, Drug: Placebo8 subjects will be randomized to receive middle dose of STSA-1301 subcutaneous injection or dose-matched placebo (Third cohort) |
| high dose group | Experimental | Drug: STSA-1301 subcutaneous injection, Drug: Placebo8 subjects will be randomized to receive high dose of STSA-1301 subcutaneous injection or dose-matched placebo (Fourth cohort) |
| highest dose group | Experimental | Drug: STSA-1301 subcutaneous injection, Drug: Placebo8 subjects will be randomized to receive highest dose of STSA-1301 subcutaneous injection or dose-matched placebo (Fifth cohort) |
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, male and female, aged between 18 and 65 years, inclusive;
- Body mass index: 18.0～28.0 kg/m2, inclusive; weight ≥50 kg for males and ≥45kg for females at enrollment;
- 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 3 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 (20 listed)
- Pregnant or lactating women;
- 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.
- After splenectomy or any major surgery within 6 months prior to screening;
- Subjects have an active infection or have a serious infection (leading to hospitalization or requiring parenteral antibiotic therapy) within 6 weeks prior to the first dose; subjects with clinically active or chronic uncontrolled bacterial, viral or fungal infections at screening;
- Total IgG was less than the lower limit of normal at screening. Subjects with absolute neutrophil count <1.5X109/L and/or absolute lymphocyte count <1.0X109/L;
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-1301 subcutaneous injectionSubjects will receive the administration dose on Day 0 following protocol requirements. | Drug | high dose group, highest dose group, low dose group, lowest dose group, middle dose group |
| PlaceboSubjects will receive the administration dose on Day 0 following protocol requirements. | Drug | high dose group, highest dose group, low dose group, lowest dose group, middle dose group |
Primary outcome
Number of treatment-related adverse events as assessed by CTCAE 5.0.
Time frame: 50 days
To evaluate the safety and tolerability of STSA-1301 subcutaneous injection in healthy adult subjects.
Safety as measured by subject incidence of treatment-emergent clinically significant changes in clinical laboratory safety tests.
Time frame: 50 days
Subject incidence of treatment-emergent clinically significant changes in clinical laboratory safety tests (Complete Blood Count (absolute counts and %), Fasting blood glucose concentration, Serum concentrations in Electrolytes, Protein, Albumin, Total Bilirubin, Blood urea nitrogen, Creatinine, Aspartate Aminotransferase, Alanine Aminotransferase, estimated Glomerular Filtration Rate (eGFR), Activated partial thromboplastin time (aPTT), Prothrombin Time test (PT) with International Normalized Ratio (INR) and Urinalysis safety tests (pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, and leukocyte esterase)).
Safety as measured by subject incidence of treatment-emergent clinically significant changes in vital signs.
Time frame: 50 days
Subject incidence of treatment-emergent clinically significant changes in vital signs (Systolic and Diastolic Blood Pressure in millimeters of mercury (mmHg), Pulse Rate in beats per minute (bpm), Respiratory Rate in beats per minute (bpm) and Body temperature in Celsius).
Safety as measured by subject incidence of treatment-emergent clinically significant changes in physical examination.
Time frame: 50 days
Subject incidence of treatment-emergent clinically significant changes in physical examination (Skin mucosa, lymph nodes, head and neck, chest, abdomen, musculoskeletal, nervous system).
Safety as measured by subject incidence of treatment-emergent clinically significant changes in Electrocardiogram (ECG).
Time frame: 50 days
Subject incidence of treatment-emergent clinically significant changes in 12-lead ECGs (Heart Rate in beats per minute (bpm), PR interval in milliseconds (msec), QRS duration in milliseconds (msec), QTc in milliseconds (msec), QT interval in milliseconds (msec)).
Maximum plasma concentration (Cmax)
Time frame: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
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: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
Time frame: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Time of maximum concentration (Tmax)
Time frame: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Elimination half-life (t1/2)
Time frame: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Elimination rate constant of plasma drug concentration in terminal phase (λz)
Time frame: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Last measurable concentration (Clast)
Time frame: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Mean residence time (MRT)
Time frame: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Clearance (CL)
Time frame: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
Apparent volume of distribution (Vz)
Time frame: Pre-dose; after dose 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days and 28 days
To evaluate the pharmacokinetics (PK) characteristics of STSA-1301
2 secondary outcomes
Change from baseline in concentration of IgG.
Time frame: Pre-dose; after dose 8 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 14 days, 21 days, 28 days and 49 days
Change from baseline in concentration of anti-drug antibody
Time frame: Pre-dose; after dose 14 days, 28 days, 49 days
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 12 Aug 2024.
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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.
Ronghua Jin, Doctor principal investigator
Beijing Ditan Hospital
1 site 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-1301 subcutaneous injection in people with Primary Immune Thrombocytopenia, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site 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 20 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 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of treatment-related adverse events as assessed by CTCAE 5.0. (time frame: 50 days). The study lists 15 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 12 Aug 2024.