Antineutrophil Cytoplasmic Antibody Associated VasculitisPhase 1NCT05702983
The Safety and Tolerability of STSA-1002 Following Subcutaneous Injection in Healthy Subjects
A Phase 1 study testing STSA-1002 subcutaneous injection in people with Antineutrophil Cytoplasmic Antibody Associated Vasculitis, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in United States.
Trial summary
An Open-label, Single-ascending dose, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002 Subcutaneous Injection in Healthy Subjects Read more about this study
- Who is it for?
- Ages 21 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Antineutrophil Cytoplasmic Antibody Associated Vasculitis
- What is being tested?
- STSA-1002 subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2023to 24 Apr 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 21 to 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects, aged ≥ 21 but ≤ 57, male and female.
- Weight: 50-93 kg; Body mass index (BMI): 21～31 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 6 months after the end of the study.
- Female and/or male subjects those meet the below criteria:
- If a female subject of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to administration of IMP, during the study, and for at least 6 months after the administration of IMP. An acceptable method of contraception includes one of the following:
- Abstinence from heterosexual intercourse, if it is the preferred and usual lifestyle choice of the subject. Additionally, it should be noted that periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) is not an acceptable method of birth control; Hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch); Intrauterine device (with or without hormones) OR agrees to use a double barrier method (e.g. condom and spermicide) during the study and for at 6 months after the administration of IMP.
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- If a female subject of non-childbearing potential - should have been surgically sterilized at least 6 months before screening (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in the postmenopausal state (at least 1 year without menses), as confirmed by Follicle-stimulating hormone (FSH) levels (≥ 40 mIU/mL).
- A male subject that engages in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g. condom and spermicide) and agree to not donate sperm during the study and for at least 6 months after the administration of IMP.
- 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
- 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.
- History of tuberculosis or a recent history of infection within the past 4 weeks.
- History of recurrent infections.
- Presence of clinically significant laboratory values during the screening period, as defined by an Investigator.
- Presence of clinically significant vital signs values or of electrocardiogram (ECG) abnormalities during the screening period, as defined by an Investigator.
- Subjects who have autoimmune disease or immunodeficiency, or have a family history of related diseases.
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- Subjects who have history of hypersensitivity or clinically significant allergic reaction to any drug, biologic, food or vaccine.
- Positive screening test results for human immunodeficiency virus (HIV-1/HIV-2) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb).
- Subjects who have received treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening.
- Subjects who have participated in any vaccine clinical study or have received any live vaccine within 3 months prior to the IMP administration or plan to receive live vaccines during the study period, and subjects who have received inactivated or attenuated vaccines 28 days prior to the IMP administration or plan to receive inactivated or attenuated vaccines within 2 months after the end of the study. If the subject has received any SARS-CoV-2 vaccine prior to screening, enrollment must be delayed until the biologic impact of the vaccine is stabilized, as determined by discussion between the investigator and the sponsor.
- 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 (for any illness) within the previous 3 months, and have previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 7 days prior to IMP administration.
- Subjects whose daily consumption of coffee, tea and/or cola is more than 750 mL or 25 fl. oz in the last 30 days before enrollment.
- Subjects who have a positive urine alcohol test or urine drug test before enrollment.
- Subjects who have nicotine consumption (e.g., smoking, nicotine patch, nicotine chewing gum, or electronic cigarettes) within 3 months prior to screening and inability to refrain from nicotine consumption from screening until end of study.
- Female subjects who are pregnant or breastfeeding during the screening period and on admission.
- Subjects whose daily consumption of alcohol at the time of screening or at any time within the prior 2 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%).
- History of drug or alcohol abuse (as defined by the investigator), or addiction within 1 year prior to screening.
- Subjects who have undergone major surgery within 6 months of screening, or who will have elective surgery that will occur during the study period.
- Subjects who have donated either more than approximately 500 mL of blood (exclusive plasma donation) within 56 days (8 weeks) prior to screening or any plasma within 7 days (1 week) prior to screening.
- Subjects fails or is unwilling to abstain from strenuous physical activities for at least 48 hours prior to IMP administration and throughout the study.
- 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.
United States1 site
AltaSciences Clinical Kansas, Inc
Overland Park, Kansas, 66212
About this study
Official title: An Open-label, Single-ascending Dose, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002 Subcutaneous Injection in Healthy Subjects
An Open-label, Single-ascending dose, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002 Subcutaneous Injection in Healthy Subjects
- Being tested
- STSA-1002 subcutaneous injection
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STSA-1002 subcutaneous injectionDrug
Subjects will receive a single low dose on day 1 following protocol requirements.
STSA-1002 subcutaneous injectionDrug
Subjects will receive a single high dose on day 1 following protocol requirements.
| Study group | Role | What they receive |
|---|---|---|
| STSA-1002 subcutaneous injection: dose 1 (First cohort) | Experimental | Not described Receives: Drug: STSA-1002 subcutaneous injection |
| STSA-1002 subcutaneous injection: dose 2 (Second cohort) | Experimental | Not described Receives: Drug: STSA-1002 subcutaneous injection |
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 toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: 50 days
Abnormal clinical laboratory values as assessed by toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (blood hematology, blood chemistry, urinalysis, etc.)
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: 50 days
Abnormal vital signs as assessed by toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (body temperature, pulse rate, blood pressure and respiratory rate)
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: 50 days
Abnormal physical examination
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: 50 days
Abnormal electrocardiogram (ECG): heart rate, PR and QT intervals, QTcF and QRS duration
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: 50 days
Maximum plasma concentration (Cmax)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
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 subcutaneous injection in healthy adult subjects
Measured: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
Time of maximum concentration (Tmax)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
elimination half-life (t1/2)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
elimination rate constant of plasma drug concentration in terminal phase (λz)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
last measurable concentration (Clast)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
mean residence time (MRT)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
clearance (CL)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
apparent volume of distribution (Vz)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Measured: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
Secondary outcomes (2)
Change from baseline in concentration of free C5a
To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 subcutaneous injection in healthy subjects
Measured: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
anti-drug antibody
To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 subcutaneous injection in healthy subjects
Measured: Pre-dose; after dose 336hours, 840hours, 1176hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start31 Jan 2023
- Primary completion11 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antineutrophil Cytoplasmic Antibody Associated VasculitisStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin K Kankam, Doctor, Principal investigator, Altasciences Company Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702983
- Sponsor's protocol ID
- STSA-1002-S01
- Status last verified
- May 2023
- First submitted
- 23 Dec 2022
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-ascending Dose, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002 Subcutaneous Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05702983
- Acronym / sponsor ID
- STSA-1002-S01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Staidson (Beijing) Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 27 Jan 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.
An Open-label, Single-ascending dose, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002 Subcutaneous Injection in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STSA-1002 subcutaneous injection: dose 1 (First cohort) | Experimental | Drug: STSA-1002 subcutaneous injection |
| STSA-1002 subcutaneous injection: dose 2 (Second cohort) | Experimental | Drug: STSA-1002 subcutaneous injection |
Who may qualify
- Ages
- 21 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy subjects, aged ≥ 21 but ≤ 57, male and female.
- Weight: 50-93 kg; Body mass index (BMI): 21～31 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 6 months after the end of the study.
- Female and/or male subjects those meet the below criteria:
- If a female subject of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to administration of IMP, during the study, and for at least 6 months after the administration of IMP. An acceptable method of contraception includes one of the following:
Key exclusion criteria (21 listed)
- 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.
- History of tuberculosis or a recent history of infection within the past 4 weeks.
- History of recurrent infections.
- Presence of clinically significant laboratory values during the screening period, as defined by an Investigator.
- 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 subcutaneous injectionSubjects will receive a single low dose on day 1 following protocol requirements. | Drug | STSA-1002 subcutaneous injection: dose 1 (First cohort) |
| STSA-1002 subcutaneous injectionSubjects will receive a single high dose on day 1 following protocol requirements. | Drug | STSA-1002 subcutaneous injection: dose 2 (Second cohort) |
Primary outcome
Number of treatment-related adverse events as assessed by toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials
Time frame: 50 days
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Abnormal clinical laboratory values as assessed by toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (blood hematology, blood chemistry, urinalysis, etc.)
Time frame: 50 days
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Abnormal vital signs as assessed by toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (body temperature, pulse rate, blood pressure and respiratory rate)
Time frame: 50 days
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Abnormal physical examination
Time frame: 50 days
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Abnormal electrocardiogram (ECG): heart rate, PR and QT intervals, QTcF and QRS duration
Time frame: 50 days
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Maximum plasma concentration (Cmax)
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection 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: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Time of maximum concentration (Tmax)
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
elimination half-life (t1/2)
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
elimination rate constant of plasma drug concentration in terminal phase (λz)
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
last measurable concentration (Clast)
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
mean residence time (MRT)
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
clearance (CL)
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
apparent volume of distribution (Vz)
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
2 secondary outcomes
Change from baseline in concentration of free C5a
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
anti-drug antibody
Time frame: Pre-dose; after dose 336hours, 840hours, 1176hours
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 26 May 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.
Martin K Kankam, Doctor principal investigator
Altasciences Company Inc.
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-1002 subcutaneous injection in people with Antineutrophil Cytoplasmic Antibody Associated Vasculitis, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in United States.
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 10 inclusion and 21 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 26 May 2023. 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 United States. 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 toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (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 26 May 2023.