SARS-CoV-2 InfectionPhase 1NCT05523739
Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients
A Phase 1 study testing STI-1558 in people with SARS-CoV-2 Infection, run by Zhejiang ACEA Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety of STI-1558 in healthy subjects and the safety, pharmacokinetics, and efficacy in SARS-CoV-2-Positive subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- STI-1558
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2022to 29 Mar 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
- Part 1
- Subjects are fully informed of the study and sign the informed consent document prior to any procedure.
- Healthy subjects aged ≥18 but ≤45 years old, regardless of gender.
- BMI ≥18, but ≤30kg/m2, and weight ≥45, but ≤100kg.
- Good health status, with normal or abnormal and not clinically significant (NCS) results of medical history, vital signs, physical examination, 12-lead electrocardiogram, laboratory tests (blood routine, blood chemistry, urine routine, coagulation function) and thyroid function (TSH, FT3, FT4) during the screening period.
- Must be willing and able to comply with all planned study procedures.
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- Women of childbearing potential (WOCBP) (infertile women defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy or bilateral tubal ligation/closure, or who are infertile due to a congenital or acquired condition or spontaneously menopausal for ≥ 12 months) must have a negative blood pregnancy test during screening. Fertility female and male subjects must use a highly effective method of contraception from the screening period to 90 days after the last dose of study drug.
- Part 2
- Subjects are fully informed of the study and sign the informed consent document prior to any procedure.
- Age ≥ 18, but < 65 years old, gregardless of gender.
- BMI ≥18, but ≤30kg/m2, and weight ≥45, but ≤100kg.
- Asymptomatic or mild patients diagnosed with SARS-CoV-2 positive according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9).
- First positive for SARS-CoV-2 in specimens such as nasal or oropharyngeal swabs within 5 days prior to D1 (≤5 days from D1) using nucleic acid amplification assays.
- Requirements for laboratory test values, including:
- Alanine aminotransferase (AST) ≤ 2.5×ULN
- Aspartate aminotransferase (ALT) ≤ 2.5×ULN
- Total bilirubin (TBIL) ≤ 2 x ULN (≤ 3.0 x ULN if diagnosed with Gilbert's syndrome)
- Absolute neutrophil count (ANC) ≥ 1.5×109/L
- Platelet (PLT)≥ 100 ×109/L
- Hemoglobin (HB) ≥ 110 g/L
- International Normalized Ratio (INR) <1.5
- Partially activated prothrombin time (APTT) < 1.5×ULN
- Creatinine clearance (according to CKD-EPI formula) ≥ 45mL/min
- QTcF ≤ 450msec (male); QTcF ≤ 470msec (female).
- Must be willing and able to comply with all planned study procedures.
- Women of childbearing potential (WOCBP) (infertile women defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy or bilateral tubal ligation/closure, or who are infertile due to a congenital or acquired condition or spontaneously menopausal for ≥ 12 months) must have a negative blood pregnancy test during screening. Fertility female and male subjects must use a highly effective method ofcontraception from the screening period to 90 days after the last dose of study drug.
Who cannot join
- Subjects who faint with needles, faint with blood, or have difficulty collecting venous blood.
- Known hypersensitivity to any of the ingredients of this product.
- Participated in an interventional clinical trial within 30 days before D1 or within 5 half-lives (whichever is longer).
- Subjects who have a history of gastrointestinal (such as duodenal ulcer, gastrointestinal bleeding), liver or kidney-related medical history, or other medical history that may affect the absorption, distribution, metabolism, and excretion of oral drugs as assessed by the investigator.
- Subjects who have undergone major surgery within 3 months prior to screening, or who have not fully recovered from surgery, or who plan to undergo surgery during the study period.
- Take foods, juices or beverages containing alcohol, grapefruit, lime, cinchona bark and quinine within 24 hours prior to D1.
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- Use of BCRP substrate drugs within 7 days prior to D1 (see "6.5.1 Prohibited Drugs and Treatments").
- History of substance abuse within 2 years prior to screening.
- Subjects who have donated blood (including blood components donation) or lost more than 400 mL of blood within 3 months prior to screening.
- History of alcohol abuse (defined as: more than 14 units of alcohol per week, 1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of spirit containing 40% alcohol) within 3 months prior to screening.
- Refusal to abstain from smoking after signing the informed consent form and during the study.
- Excessive consumption of tea, coffee or caffeinated beverages (defined as: at least 8 cups per day, 1 cup = 250 ml) within 3 months prior to screening.
- Currently pregnant or breastfeeding.
- According to the investigator's judgment, the subject has any other disease or condition that may affect the normal completion of the study or the evaluation of the study data, or other conditions that are not suitable for participation in this study.
- Healthy subjects are not allowed to join the part 1 if they meet any of the following criteria:
- Relevant history or clinical signs or symptoms associated with clinically significant diseases of the metabolic/endocrine system, heart, liver, kidney, hematolymphatic system, respiratory system, immune system, digestive system, genitourinary system, neurological or psychiatric system within 3 months prior to and during the screening period as assessed by the investigator.
- History of fever within 14 days prior to D1.
- Liver function test indicators meet the following requirements, including:
- Alanine aminotransferase (AST) > 1.5 x ULN, or
- Aspartate aminotransferase (ALT) > 1.5×ULN
- QTcF > 450msec (male); QTcF > 470msec (female).
- Take any over-the-counter drugs (including but not limited to vitamins, prophylaxis, botanical health products, etc.) or any prescription drugs within 14 days prior to D1 or within 5 half-lives (whichever is longer) (see Exclusion Criteria 13 for BCRP substrate drug limitations) and Chinese herbal medicines, excluding contraceptive drugs or topical drugs that can be applied according to the investigator's assessment.
- Subjects who have been vaccinated within 14 days prior to D1, or who plan to be vaccinated during the study.
- Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.
- On D-1, the nucleic acid amplification detection method will be used to test positive for SARS-CoV-2 in specimens such as nasal or oropharyngeal swabs.
- SARS-CoV-2 positive subjects are not allowed to join the part 2 if they meet any of the following criteria:
- History of COVID-19-related hospitalization within 3 months prior to D1.
- According to the investigator's judgment, the subject may progress to severe/critical COVID-19 before randomization.
- Within 24 hours prior to D1 (≤24h from D1), SpO2 ≤ 93% or PaO2/FiO2 ≤300 in indoor air at sea level, or respiratory rate ≥30 times/min, or heart rate ≥125 times/min.
- Requires mechanical ventilation or anticipates an urgent need for mechanical ventilation.
- Suspected or diagnosed serious bacterial, fungal, viral, or other infection (except for COVID-19 infection), or would affect the endpoint assessment of this study according to the investigator assessment.
- Active or uncontrolled liver disease: including primary biliary cirrhosis, Child-Pugh class B or C, acute liver failure, etc.
- Being on dialysis.
- Use any drug known to strongly induce or strongly inhibit CYP3A4 enzyme metabolism within 7 days prior to D1 .
- Treatment of COVID-19 with systemic or inhaled steroids within 30 days prior to D1 (long-term stable dose therapy for chronic concomitant disease, without increasing dose).
- Have previously received COVID-19 patients' convalescent plasma or anti-SARS-CoV-2 neutralizing antibody or related antiviral therapy.
- Subjects who have been vaccinated within 14 days prior to D1, or who plan to be vaccinated during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase I Clinical Study Evaluating the Safety of a Single Ascending Dose of STI-1558 in Healthy Subjects and the Safety, Pharmacokinetics, and Efficacy of Multiple Ascending Doses of STI-1558 in SARS-CoV-2-Positive Subjects
The purpose of this study is to evaluate the safety of STI-1558 in healthy subjects and the safety, pharmacokinetics, and efficacy in SARS-CoV-2-Positive subjects.
Read the detailed description
This is a two-part, randomized, double-blind, placebo-controlled study evaluating the safety and pharmacokinetics (PK) of a single ascending dose of STI-1558 in healthy subjects and the safety, PK and efficacy of a multiple ascending dose in SARS-CoV-2-positive subjects.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- STI-1558
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI-1558Drug
An oral small molecule prodrug that effectively inhibits the SARS-CoV-2 main protease (Mpro).
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort 1 | Experimental | Participants will receive a single 300 mg dose of STI-1558 or placebo. Cohort 1 will dose 6 subjects to STI-1558 and 2 subjects to placebo. Receives: Drug: STI-1558 |
| Part 1: Cohort 2 | Experimental | Participants will receive a single 600 mg dose of STI-1558 or placebo. Cohort 2 will dose 6 subjects to STI-1558 and 2 subjects to placebo. Receives: Drug: STI-1558 |
| Part 1: Cohort 3 | Experimental | Participants will receive a single 1200 mg dose of STI-1558 or placebo. Cohort 3 will dose 6 subjects to STI-1558 and 2 subjects to placebo. Receives: Drug: STI-1558 |
| Part 1: Cohort 4 | Experimental | Participants will receive a single 2000 mg dose of STI-1558 or placebo. Cohort 4 will dose 6 subjects to STI-1558 and 2 subjects to placebo. Receives: Drug: STI-1558 |
| Part 2: Cohort 1 | Experimental | Participants will receive a 300 mg dose of STI-1558 or placebo q12h on Day1 to Day7 and once in the morning on Day8 for a total of 15 doses.
Cohort 1 will dose 6 subjects to STI-1558 and 2 subjects to placebo. Receives: Drug: STI-1558 |
| Part 2: Cohort 2 | Experimental | Participants will receive a 600 mg dose of STI-1558 or placebo q12h on Day1 to Day7 and once in the morning on Day8 for a total of 15 doses.
Cohort 2 will dose 16 subjects to STI-1558 and 8 subjects to placebo. Receives: Drug: STI-1558 |
| Part 2: Cohort 3 | Experimental | Participants will receive a 800 mg dose of STI-1558 or placebo q12h on Day1 to Day7 and once in the morning on Day8 for a total of 15 doses.
Cohort 3 will dose 16 subjects to STI-1558 and 8 subjects to placebo. Receives: Drug: STI-1558 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE, laboratory tests, thyroid function, physical examination, vital signs.
Incidence and severity of AEs up to 6 days for part 1 and 21 days for part 2 post-dosing.
Measured: Day 7 for part 1 and day 29 for part 2.
Secondary outcomes (6)
Proportion of changes from baseline in SARS-CoV-2 RNA quantification levels on D3, D5, D7, D10, D14, D21, D29.
2 nasal swabs will be taken from both nostrils for RNA test
Measured: Day3, Day5, Day7, Day10, Day14, Day21, Day29
Proportion of SARS-CoV-2 RNA quantification levels below the lower limit of quantification on D3, D5, D7, D10, D14, D21, D29.
2 nasal swabs will be taken from both nostrils for RNA test
Measured: Day3, Day5, Day7, Day10, Day14, Day21, Day29.
Pharmacokinetic parameter of AUC
Area under the concentration-time curve from time 0 to Day1, Day2, Day3 for part 1 and Day1, Day6, Day7, Day8 for part 2
Measured: Day1, Day2, Day3 for part 1 and Day1, Day6, Day7, Day8 for part 2
Pharmacokinetic parameter of Cmax
Measured by maximum observed concentration
Measured: Day1, Day2, Day3 for part 1 and Day1, Day6, Day7, Day8 for part 2
Pharmacokinetic parameter of Tmax
Measured by time to maximum observed concentration
Measured: Day1, Day2, Day3 for part 1 and Day1, Day6, Day7, Day8 for part 2
Pharmacokinetic parameter of t½
Terminal elimination half-life after dosing
Measured: Day1, Day2, Day3 for part 1 and Day1, Day6, Day7, Day8 for part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start16 Sep 2022
- Primary completion21 Dec 2022
- Study completion29 Mar 2023
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 SARS-CoV-2 InfectionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang ACEA Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523739
- Sponsor's protocol ID
- MPR-COV-101CN
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mao L, Shaabani N, Zhang X, Jin C, Xu W, Argent C, Kushnareva Y, Powers C, Stegman K, Liu J, Xie H, Xu C, Bao Y, Xu L, Zhang Y, Yang H, Qian S, Hu Y, Shao J, Zhang C, Li T, Li Y, Liu N, Lin Z, Wang S, Wang C, Shen W, Lin Y, Shu D, Zhu Z, Kotoi O, Kerwin L, Han Q, Chumakova L, Teijaro J, Royal M, Brunswick M, Allen R, Ji H, Lu H, Xu X. Olgotrelvir, a dual inhibitor of SARS-CoV-2 Mpro and cathepsin L, as a standalone antiviral oral intervention candidate for COVID-19. Med. 2024 Jan 12;5(1):42-61.e23. doi: 10.1016/j.medj.2023.12.004. Epub 2024 Jan 4.
PubMed 38181791
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase I Clinical Study Evaluating the Safety of a Single Ascending Dose of STI-1558 in Healthy Subjects and the Safety, Pharmacokinetics, and Efficacy of Multiple Ascending Doses of STI-1558 in SARS-CoV-2-Positive Subjects
- ClinicalTrials.gov ID
- NCT05523739
- Acronym / sponsor ID
- MPR-COV-101CN
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Zhejiang ACEA Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 31 Aug 2022 (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.
The purpose of this study is to evaluate the safety of STI-1558 in healthy subjects and the safety, pharmacokinetics, and efficacy in SARS-CoV-2-Positive subjects.
Detailed description
This is a two-part, randomized, double-blind, placebo-controlled study evaluating the safety and pharmacokinetics (PK) of a single ascending dose of STI-1558 in healthy subjects and the safety, PK and efficacy of a multiple ascending dose in SARS-CoV-2-positive subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1 | Experimental | Drug: STI-1558Participants will receive a single 300 mg dose of STI-1558 or placebo. Cohort 1 will dose 6 subjects to STI-1558 and 2 subjects to placebo. |
| Part 1: Cohort 2 | Experimental | Drug: STI-1558Participants will receive a single 600 mg dose of STI-1558 or placebo. Cohort 2 will dose 6 subjects to STI-1558 and 2 subjects to placebo. |
| Part 1: Cohort 3 | Experimental | Drug: STI-1558Participants will receive a single 1200 mg dose of STI-1558 or placebo. Cohort 3 will dose 6 subjects to STI-1558 and 2 subjects to placebo. |
| Part 1: Cohort 4 | Experimental | Drug: STI-1558Participants will receive a single 2000 mg dose of STI-1558 or placebo. Cohort 4 will dose 6 subjects to STI-1558 and 2 subjects to placebo. |
| Part 2: Cohort 1 | Experimental | Drug: STI-1558Participants will receive a 300 mg dose of STI-1558 or placebo q12h on Day1 to Day7 and once in the morning on Day8 for a total of 15 doses. Cohort 1 will dose 6 subjects to STI-1558 and 2 subjects to placebo. |
| Part 2: Cohort 2 | Experimental | Drug: STI-1558Participants will receive a 600 mg dose of STI-1558 or placebo q12h on Day1 to Day7 and once in the morning on Day8 for a total of 15 doses. Cohort 2 will dose 16 subjects to STI-1558 and 8 subjects to placebo. |
| Part 2: Cohort 3 | Experimental | Drug: STI-1558Participants will receive a 800 mg dose of STI-1558 or placebo q12h on Day1 to Day7 and once in the morning on Day8 for a total of 15 doses. Cohort 3 will dose 16 subjects to STI-1558 and 8 subjects to placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Part 1
- Part 2
Key exclusion criteria (37 listed)
- Subjects who faint with needles, faint with blood, or have difficulty collecting venous blood.
- Known hypersensitivity to any of the ingredients of this product.
- Participated in an interventional clinical trial within 30 days before D1 or within 5 half-lives (whichever is longer).
- Subjects who have a history of gastrointestinal (such as duodenal ulcer, gastrointestinal bleeding), liver or kidney-related medical history, or other medical history that may affect the absorption, distribution, metabolism, and excretion of oral drugs as assessed by the investigator.
- Subjects who have undergone major surgery within 3 months prior to screening, or who have not fully recovered from surgery, or who plan to undergo surgery during the study period.
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 |
|---|---|---|
| STI-1558An oral small molecule prodrug that effectively inhibits the SARS-CoV-2 main protease (Mpro). | Drug | Part 1: Cohort 1, Part 1: Cohort 2, Part 1: Cohort 3, Part 1: Cohort 4, Part 2: Cohort 1, Part 2: Cohort 2, Part 2: Cohort 3 |
Primary outcome
AE, laboratory tests, thyroid function, physical examination, vital signs.
Time frame: Day 7 for part 1 and day 29 for part 2.
Incidence and severity of AEs up to 6 days for part 1 and 21 days for part 2 post-dosing.
6 secondary outcomes
Proportion of changes from baseline in SARS-CoV-2 RNA quantification levels on D3, D5, D7, D10, D14, D21, D29.
Time frame: Day3, Day5, Day7, Day10, Day14, Day21, Day29
Proportion of SARS-CoV-2 RNA quantification levels below the lower limit of quantification on D3, D5, D7, D10, D14, D21, D29.
Time frame: Day3, Day5, Day7, Day10, Day14, Day21, Day29.
Pharmacokinetic parameter of AUC
Time frame: Day1, Day2, Day3 for part 1 and Day1, Day6, Day7, Day8 for part 2
Pharmacokinetic parameter of Cmax
Time frame: Day1, Day2, Day3 for part 1 and Day1, Day6, Day7, Day8 for part 2
Pharmacokinetic parameter of Tmax
Time frame: Day1, Day2, Day3 for part 1 and Day1, Day6, Day7, Day8 for part 2
Pharmacokinetic parameter of t½
Time frame: Day1, Day2, Day3 for part 1 and Day1, Day6, Day7, Day8 for part 2
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 Aug 2023.
- Derived from this study: PubMed 38181791Mao L, Shaabani N, Zhang X, Jin C, Xu W, Argent C, Kushnareva Y, Powers C, Stegman K, Liu J, Xie H, Xu C, Bao Y, Xu L, Zhang Y, Yang H, Qian S, Hu Y, Shao J, Zhang C, Li T, Li Y, Liu N, Lin Z, Wang S, Wang C, Shen W, Lin Y, Shu D, Zhu Z, Kotoi O, Kerwin L, Han Q, Chumakova L, Teijaro J, Royal M, Brunswick M, Allen R, Ji H, Lu H, Xu X. Olgotrelvir, a dual inhibitor of SARS-CoV-2 Mpro and cathepsin L, as a standalone antiviral oral intervention candidate for COVID-19. Med. 2024 Jan 12;5(1):42-61.e23. doi: 10.1016/j.medj.2023.12.004. Epub 2024 Jan 4.
- 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.
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 STI-1558 in people with SARS-CoV-2 Infection, run by Zhejiang ACEA Pharmaceutical 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 26 inclusion and 37 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 Aug 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 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?
AE, laboratory tests, thyroid function, physical examination, vital signs. (time frame: Day 7 for part 1 and day 29 for part 2.). 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 NCT05523739, 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 Aug 2023.