AsthmaPhase 1NCT04480762
A Trial of SHR-1703 in Healthy Adults
A Phase 1 study testing SHR-1703 in people with Asthma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
SHR-1703 is a monoclonal antibody under development for severe asthma. This study is the first study in Healthy subjects. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose SHR-1703 administered subcutaneously in Chinese healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- SHR-1703
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2020to 21 Sep 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Able to read, comprehend and write at a sufficient level to complete study materials.
- Aged 18 to 55 years (inclusive).
- Body weight equal or more than 45.0 kg and BMI within the range between 19 and 24kg/m2 (inclusive).
- AST, ALT, alkaline phosphatase and bilirubin equal or less than ULN.
- Healthy Chinese as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the Jiangsu HengRui Medicine Co Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Subjects must commit to consistent and correct use of an acceptable method of birth control from the start of trial to the next month after the last visit.
- A negative pre-study drug/alcohol screen.
Who cannot join
- Allergy/intolerance to the SHR-1703 and/or excipients in the formulation, or any other Biologics
- Positive Hepatitis B surface antigen or positive Hepatitis C antibody or human immunodeficiency virus - HIV antibody or Syphilis serological test at screening
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to screening in the current study: 3 months, 5 half-lives or fellow-up period of the investigational product (whichever is longer).
- Use of any medicines, including prescription or Over-the-Counter drugs (including herbal and dietary supplements, not including regular vitamins and paracetamol which be used occasionally in the recommended dose) within 1 month or 5 half-lives (whichever is longer) prior to the administration.
- Subjects who have received immune inhibitors within 6 months prior to screening
- Subjects who have had severe trauma or surgery within 6 months prior to screening, or who plan to undergo surgery during the trial.
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- Blood donation history within 1 month prior to screening ,or severe blood loss(total blood volume≥400 ml)，or blood transfusion within 2 months
- Subjects who are inoculated live (attenuated) vaccine within 1 month prior to screening or during the trial.
- Subject who is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
- At the discretion of the investigator, a subject will not be eligible for this study if he/she is in the following cases: the subject is not able to complete the study, or present a significant risk to the subject, or present other factors(e.g. infirmity. etc.) that may prevent the enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-1703 Injection Administered Subcutaneously in Healthy Subjects
SHR-1703 is a monoclonal antibody under development for severe asthma. This study is the first study in Healthy subjects. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose SHR-1703 administered subcutaneously in Chinese healthy subjects.
Read the detailed description
This study will be conducted at 1 study center in China. Approximately 42 healthy Chinese male and female subjects, aged 18 to 55 inclusive, will be randomized to receive a single SC administration of SHR-1703: Treatment 1, Treatment 2, Treatment 3, Treatment 4 and Treatment 5. Each subject will participate in only 1 treatment group. The total length of the study for each subject is up to 190 days (28 days of screening and 155+/- 7 days of further study visits).
- Conditions
- Asthma
- Being tested
- SHR-1703, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1703Drug
SHR-1703
PlaceboDrug
Placebo of the SHR-1703
| Study group | Role | What they receive |
|---|---|---|
| SHR-1703-Subcutaneous administration of Dose 1 | Experimental | A single subcutaneous injection of SHR-1703 (Dose 1) or Placebo Receives: Drug: SHR-1703; Drug: Placebo |
| SHR-1703-Subcutaneous administration of Dose 2 | Experimental | A single subcutaneous injection of SHR-1703 (Dose 2) or Placebo Receives: Drug: SHR-1703; Drug: Placebo |
| SHR-1703-Subcutaneous administration of Dose 3 | Experimental | A single subcutaneous injection of SHR-1703 (Dose 3) or Placebo Receives: Drug: SHR-1703; Drug: Placebo |
| SHR-1703-Subcutaneous administration of Dose 4 | Experimental | A single subcutaneous injection of SHR-1703 (Dose 4) or Placebo Receives: Drug: SHR-1703; Drug: Placebo |
| SHR-1703-Subcutaneous administration of Dose 5 | Experimental | A single subcutaneous injection of SHR-1703 (Dose 5) or Placebo Receives: Drug: SHR-1703; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events (AEs) and serious adverse events (SAEs)
The number and percentage of subjects with treatment-emergent AE/SAE/AE by severity/drug-related AE/drug-related SAE/death in each dose level group and overall. AE/SAE will be displayed by MedDRA SOC and/or PT
Measured: From Day 1 to Days 155
Safety as determined by abnormality in haematology
Measurement of red blood cell count, white blood cell count, haemoglobin and platelets
Measured: From Day 1 to Days 155
Safety as determined by abnormality in clinical chemistry
Measurement of kidney function (e.g.urea ,creatinine, Uric acid), liver function(ALP, ALT, AST, albumin, total bilirubin), lipid profile(total cholesterol, triglycerides), ions.
Measured: From Day 1 to Days 155
Safety as determined by abnormality in urinalysis
Measurement of glucose, ketones, leukocytes, blood and protein
Measured: From Day 1 to Days 155
Safety as determined by evaluation of blood pressure in mmHg
Measurement of blood pressure (systolic and diastolic in mmHg)
Measured: From Day 1 to Days 155
Safety as determined by evaluation of Pulse rate in beats per minute
Measurement of Pulse rate in beats per minute
Measured: From Day 1 to Days 155
Safety as determined by evaluation of body temperature in degree Celsius
Measurement of body temperature in degree Celsius
Measured: From Day 1 to Days 155
Safety as determined by evaluation of Respiratory rate in beats per minute
Measurement of Respiratory rate in beats per minute
Measured: From Day 1 to Days 155
Safety as determined by analysis of 12-lead ECG variables: heart rate (beats per minute)
The ECG variables will be summarized by absolute value at each visit by treatment group, together with the corresponding changes from baseline.
Measured: From Day 1 to Days 155
Safety as determined by analysis of 12-lead ECG variables: PR, QRS, QT and QTcF (milliseconds)
The ECG variables will be summarized by absolute value at each visit by treatment group.
Measured: From Day 1 to Days 155
Secondary outcomes (8)
Maximum observed concentration (Cmax)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
Measured: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Time to maximum observed concentration (tmax)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
Measured: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Area under the concentration-time curve from 0 to the last measurable time point (AUC0-t)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
Measured: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
Measured: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Apparent clearance (CL/F)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
Measured: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Apparent volume of distribution at terminal phase (Vz/F)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
Measured: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Time for concentration to decrease by 50% (concentration half-life) (t1/2)
To assess the Pharmacokinetic profile of Subcutaneously administration of SHR-1703 in healthy Chinese subjects.
Measured: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Anti-drug antibody (ADA) as determined by evaluation of ADA positive percentage and ADA negative percentage
To assess the immunogenicity of SHR-1703
Measured: From Day 1 to Follow-UP ( Days 8, Days 15, Days 29, Days 92, Days 120, Days 155)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start4 Aug 2020
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480762
- Sponsor's protocol ID
- SHR-1703-101
- Status last verified
- Nov 2022
- First submitted
- 15 Jul 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang L, Fang Y, Luo Y, Fu M, Shen K, Luo Z. Safety, pharmacokinetics and pharmacodynamics of SHR-1703, an innovative long-acting anti-interleukin-5 monoclonal antibody, in healthy subjects: a randomized, double-blind, dose-escalation, placebo-controlled phase I study. Expert Opin Investig Drugs. 2024 Jul;33(7):741-752. doi: 10.1080/13543784.2024.2361065. Epub 2024 Jun 3.
PubMed 38805242
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-1703 Injection Administered Subcutaneously in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04480762
- Acronym / sponsor ID
- SHR-1703-101
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 21 Jul 2020 (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.
SHR-1703 is a monoclonal antibody under development for severe asthma. This study is the first study in Healthy subjects. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose SHR-1703 administered subcutaneously in Chinese healthy subjects.
Detailed description
This study will be conducted at 1 study center in China. Approximately 42 healthy Chinese male and female subjects, aged 18 to 55 inclusive, will be randomized to receive a single SC administration of SHR-1703: Treatment 1, Treatment 2, Treatment 3, Treatment 4 and Treatment 5. Each subject will participate in only 1 treatment group. The total length of the study for each subject is up to 190 days (28 days of screening and 155+/- 7 days of further study visits).
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 |
|---|---|---|
| SHR-1703-Subcutaneous administration of Dose 1 | Experimental | Drug: SHR-1703, Drug: PlaceboA single subcutaneous injection of SHR-1703 (Dose 1) or Placebo |
| SHR-1703-Subcutaneous administration of Dose 2 | Experimental | Drug: SHR-1703, Drug: PlaceboA single subcutaneous injection of SHR-1703 (Dose 2) or Placebo |
| SHR-1703-Subcutaneous administration of Dose 3 | Experimental | Drug: SHR-1703, Drug: PlaceboA single subcutaneous injection of SHR-1703 (Dose 3) or Placebo |
| SHR-1703-Subcutaneous administration of Dose 4 | Experimental | Drug: SHR-1703, Drug: PlaceboA single subcutaneous injection of SHR-1703 (Dose 4) or Placebo |
| SHR-1703-Subcutaneous administration of Dose 5 | Experimental | Drug: SHR-1703, Drug: PlaceboA single subcutaneous injection of SHR-1703 (Dose 5) or Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Able to read, comprehend and write at a sufficient level to complete study materials.
- Aged 18 to 55 years (inclusive).
- Body weight equal or more than 45.0 kg and BMI within the range between 19 and 24kg/m2 (inclusive).
- AST, ALT, alkaline phosphatase and bilirubin equal or less than ULN.
Key exclusion criteria (10 listed)
- Allergy/intolerance to the SHR-1703 and/or excipients in the formulation, or any other Biologics
- Positive Hepatitis B surface antigen or positive Hepatitis C antibody or human immunodeficiency virus - HIV antibody or Syphilis serological test at screening
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to screening in the current study: 3 months, 5 half-lives or fellow-up period of the investigational product (whichever is longer).
- Use of any medicines, including prescription or Over-the-Counter drugs (including herbal and dietary supplements, not including regular vitamins and paracetamol which be used occasionally in the recommended dose) within 1 month or 5 half-lives (whichever is longer) prior to the administration.
- Subjects who have received immune inhibitors within 6 months prior to screening
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 |
|---|---|---|
| SHR-1703SHR-1703 | Drug | SHR-1703-Subcutaneous administration of Dose 1, SHR-1703-Subcutaneous administration of Dose 2, SHR-1703-Subcutaneous administration of Dose 3, SHR-1703-Subcutaneous administration of Dose 4, SHR-1703-Subcutaneous administration of Dose 5 |
| PlaceboPlacebo of the SHR-1703 | Drug | SHR-1703-Subcutaneous administration of Dose 1, SHR-1703-Subcutaneous administration of Dose 2, SHR-1703-Subcutaneous administration of Dose 3, SHR-1703-Subcutaneous administration of Dose 4, SHR-1703-Subcutaneous administration of Dose 5 |
Primary outcome
Number of participants with Adverse events (AEs) and serious adverse events (SAEs)
Time frame: From Day 1 to Days 155
The number and percentage of subjects with treatment-emergent AE/SAE/AE by severity/drug-related AE/drug-related SAE/death in each dose level group and overall. AE/SAE will be displayed by MedDRA SOC and/or PT
Safety as determined by abnormality in haematology
Time frame: From Day 1 to Days 155
Measurement of red blood cell count, white blood cell count, haemoglobin and platelets
Safety as determined by abnormality in clinical chemistry
Time frame: From Day 1 to Days 155
Measurement of kidney function (e.g.urea ,creatinine, Uric acid), liver function(ALP, ALT, AST, albumin, total bilirubin), lipid profile(total cholesterol, triglycerides), ions.
Safety as determined by abnormality in urinalysis
Time frame: From Day 1 to Days 155
Measurement of glucose, ketones, leukocytes, blood and protein
Safety as determined by evaluation of blood pressure in mmHg
Time frame: From Day 1 to Days 155
Measurement of blood pressure (systolic and diastolic in mmHg)
Safety as determined by evaluation of Pulse rate in beats per minute
Time frame: From Day 1 to Days 155
Measurement of Pulse rate in beats per minute
Safety as determined by evaluation of body temperature in degree Celsius
Time frame: From Day 1 to Days 155
Measurement of body temperature in degree Celsius
Safety as determined by evaluation of Respiratory rate in beats per minute
Time frame: From Day 1 to Days 155
Measurement of Respiratory rate in beats per minute
Safety as determined by analysis of 12-lead ECG variables: heart rate (beats per minute)
Time frame: From Day 1 to Days 155
The ECG variables will be summarized by absolute value at each visit by treatment group, together with the corresponding changes from baseline.
Safety as determined by analysis of 12-lead ECG variables: PR, QRS, QT and QTcF (milliseconds)
Time frame: From Day 1 to Days 155
The ECG variables will be summarized by absolute value at each visit by treatment group.
8 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Time to maximum observed concentration (tmax)
Time frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Area under the concentration-time curve from 0 to the last measurable time point (AUC0-t)
Time frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
Time frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Apparent clearance (CL/F)
Time frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Apparent volume of distribution at terminal phase (Vz/F)
Time frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Time for concentration to decrease by 50% (concentration half-life) (t1/2)
Time frame: From Day 1 to Follow-UP ( Days2, Days 3,Days 4, Days 5, Days 6, Days 8, Days 11, Days 15, Days 22 , Days 29, Days 43, Days 64, Days 92, Days 120, Days 155)
Anti-drug antibody (ADA) as determined by evaluation of ADA positive percentage and ADA negative percentage
Time frame: From Day 1 to Follow-UP ( Days 8, Days 15, Days 29, Days 92, Days 120, Days 155)
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 14 Nov 2022.
- Derived from this study: PubMed 38805242Yang L, Fang Y, Luo Y, Fu M, Shen K, Luo Z. Safety, pharmacokinetics and pharmacodynamics of SHR-1703, an innovative long-acting anti-interleukin-5 monoclonal antibody, in healthy subjects: a randomized, double-blind, dose-escalation, placebo-controlled phase I study. Expert Opin Investig Drugs. 2024 Jul;33(7):741-752. doi: 10.1080/13543784.2024.2361065. Epub 2024 Jun 3.
- Individual participant dataSharing planned: Undecided
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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.
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 SHR-1703 in people with Asthma, run by Jiangsu HengRui Medicine 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 8 inclusion and 10 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 14 Nov 2022. 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 participants with Adverse events (AEs) and serious adverse events (SAEs) (time frame: From Day 1 to Days 155). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04480762, which also lists 1 linked publication.
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 14 Nov 2022.