ElectrocardiographyPhase 1NCT05988034
A Study to Assess the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Participants
A Phase 1 study testing Avacopan and Moxifloxacin in people with Electrocardiography, run by Amgen at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the effects of therapeutic and supratherapeutic doses of avacopan on the heart rate corrected QT interval, using Fridericia's formula (QTcF). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrocardiography
- What is being tested?
- Avacopan and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2019to 31 Mar 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be able to verbalize understanding of consent form and able to provide written informed consent;
- Healthy male or female: No known history of a clinically significant medical diagnosis in the opinion of the Investigator and is not receiving prescription medication except birth control therapies; this includes but is not limited to no history of heart or lung disease (including latent tuberculosis), high blood pressure, history of any cardiac or endocrine disease (including thyroid disease and diabetes); appendectomy and cholecystectomy are allowed;
- Aged ≥18 and ≤60 years at the time of screening;
- Body mass index ≥18.0 and ≤30.0 kg/m^2, and body weight of ≥50 kg, at screening and Day -2;
- Non- or ex-smoker; an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration;
- A female participant meeting 1 of the following criteria: (1) female participants of child-bearing potential using adequate contraception during and for at least 90 days after any administration of study medication; or (2) physiological postmenopausal status, defined as the following: absence of menses for at least 1 year prior to the first study drug administration (not due to amenorrhea secondary to lactation); and follicle stimulating hormone (FSH) levels ≥40 mIU/mL at screening; or (3) surgical postmenopausal status, defined as the following: bilateral oophorectomy; and absence of menses for at least 90 days prior to the first study drug administration; and FSH levels ≥40 mIU/mL at screening; or (4) surgical sterilization including tubal ligation, salpingectomy and hysterectomy. If the postmenopausal participant has an FSH of <40 mIU/mL, but meets the above criteria in either (1), (2), (3) or (4) (for all aspects other than FSH levels) as well as all the other inclusion criteria, the participant may be included in the study if the estradiol serum level measured at screening is equal to or below 150 pmol/L. If male, non-vasectomized participants with female partners of child-bearing potential must agree to use contraception and agree not to donate sperm during the study period and for 90 days after the last study drug administration;
- Willing to communicate with an investigator and site staff and comply with all study procedures and requirements.
Who cannot join
- An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second- or third-degree atrioventricular block, or one or more of the following: QRS interval >110 msec; QTcF >450 msec; PR interval >200 msec; HR <40 bpm; or any rhythm other than sinus rhythm that is interpreted an investigator to be clinically significant;
- History of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesemia. Participants will also be excluded if there is a family history of long QT syndrome or Brugada syndrome;
- A sustained supine systolic blood pressure >150 mm Hg or <90 mm Hg or a supine diastolic blood pressure >95 mm Hg or <50 mm Hg at screening or on Day -1. Blood pressure may be retested more than once in the supine position. The blood pressure abnormality is considered sustained if either the systolic or the diastolic pressure values are outside the stated limits after 3 assessments and the participant may not be randomized;
- A resting HR of <40 bpm or >100 bpm when vital signs are measured at screening or on Day -1;
- Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia;
- History of acquired immunodeficiency syndrome or positive test results for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B surface antigen at screening;
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- Positive urine drug or alcohol screen at screening or on Day -2 (admission);
- Clinically significant illness, including viral syndromes within 3 weeks prior to Day 1;
- Women who are pregnant according to a serum pregnancy test (or planning to become pregnant within the next 6 months) or currently breastfeeding, at screening or according to a urine pregnancy test on Day -2 (admission);
- Participation in another investigational drug or device study or treated with an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to Day 1;
- Received avacopan previously;
- Consumed more than 21 units of ethanol per week at any time in the 6 months prior to Day 1 (1 unit of ethanol is equivalent to 8 ounces of beer, 4 ounces of wine, or 1 ounce of spirits) or history of alcoholism and/or drug/chemical abuse within 5 years;
- Use of prescription medications (with the exception of hormone replacement therapy and hormonal birth control), including nonsteroidal anti-inflammatory drugs or sucralfate and medications known to prolong the QT/QTc interval or herbal preparations within 14 days or 5 half-lives (whichever is longer) prior to Day 1, or use of an over-the-counter medication, vitamins, or supplements (including omega-3 fish oils) within 7 days prior to Day 1;
- Use of alcohol-, caffeine-, or xanthine-containing products, Seville oranges (sour), grapefruit, or grapefruit juice, within 72 hours prior to Day 1;
- Strenuous activity (e.g., sports) from 96 hours (4 days) prior to entry into the clinical research unit (on Day -2) and throughout the study (until the final follow-up visit is conducted);
- Donated more than 500 mL of blood or significant blood loss within 60 days prior to signing the informed consent form;
- Any other medical, psychological, or social condition that, in the opinion of an investigator, would prevent the participant from fully participating in the study, would represent a concern for study compliance, or would constitute a safety concern to the participant;
- An employee of an investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as a family member of the employee or investigator;
- Known hypersensitivity to drugs including moxifloxacin;
- Participants taking strong CYP3A4 inducers (e.g., phenytoin, fosphenytoin, rifampicin, carbamazepine, St. John's Wort, nevirapine, pentobarbital, primidone, rifapentine, enzalutamide, lumacaftor, mitotane, apalutamide, quinine, rimexolone, rifaximin, rifamycin, topiramate, oxcarbazepine) or moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, dexamethasone, etravirine, nafcillin, dabrafenib, methotrexate, bexarotene, mifepristone) within 2 weeks prior to prior to Day 1;
- Positive screening tuberculosis blood test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple-dose, Randomized, Double-blind, Placebo-controlled, Active-Comparator, Parallel Study to Investigate the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Subjects
The primary objective of this study is to evaluate the effects of therapeutic and supratherapeutic doses of avacopan on the heart rate corrected QT interval, using Fridericia's formula (QTcF).
- Conditions
- Electrocardiography
- Being tested
- Avacopan, Moxifloxacin, Placebo for avacopan, Placebo for moxifloxacin
- Keywords
- Complement 5a receptor (C5aR), Anti-neutrophil cytoplasmic antibody-associated vasculitis, Complement, Vasculitis
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvacopanDrug
Administered orally.
MoxifloxacinDrug
Administered orally.
Placebo for avacopanDrug
Administered orally.
Placebo for moxifloxacinDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Avacopan | Experimental | Participants will be randomized to receive multiple doses of avacopan orally twice daily (BID): 30 mg for 7 days and 100 mg for 7 days, for a total of 14 dosing days, and placebo for moxifloxacin on Days 1 and 15. Receives: Drug: Avacopan; Drug: Placebo for moxifloxacin |
| Cohort 2A: Moxifloxacin/Placebo | Active comparator | Participants will be randomized to receive moxifloxacin 400 mg orally on Day 1, placebo for avacopan BID on Days 1 to 14, and placebo for moxifloxacin on Day 15. Receives: Drug: Moxifloxacin; Drug: Placebo for avacopan; Drug: Placebo for moxifloxacin |
| Cohort 2B: Placebo/Moxifloxacin | Active comparator | Participants will be randomized to receive placebo for moxifloxacin orally on Day 1, placebo for avacopan BID on Days 1 to 14, and moxifloxacin 400 mg orally on Day 15. Receives: Drug: Moxifloxacin; Drug: Placebo for avacopan; Drug: Placebo for moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in QTcF
Measured: Day -1 (baseline) and up to Day 14
Secondary outcomes (21)
Change from Baseline in Heart Rate (HR)
Measured: Day -1 (baseline) and Days 1, 7, and 14
Change from Baseline in Time Between P and R Wave (PR Interval)
Measured: Day -1 (baseline) and Days 1, 7, and 14
Change from Baseline in Complex Between Q and S Wave (QRS Interval)
Measured: Day -1 (baseline) and Days 1, 7, and 14
Placebo-corrected Change from Baseline in HR
Measured: Day -1 (baseline) and Days 1, 7, and 14
Placebo-corrected Change from Baseline in QTcF
Measured: Day -1 (baseline) and Days 1, 7, and 14
Placebo-corrected Change from Baseline in PR Interval
Measured: Day -1 (baseline) and Days 1, 7, and 14
Placebo-corrected Change from Baseline in QRS Interval
Measured: Day -1 (baseline) and Days 1, 7, and 14
Number of Participants with Categorical Increases in QTcF from Baseline
Increases in absolute QTcF interval values from baseline >450 and ≤480 milliseconds (msec), >480 and ≤500 msec, or >500 msec, and changes from baseline of >30 and ≤60 msec, or >60 msec.
Measured: Day -1 (baseline) and Days 1, 7, and 14
Number of Participants with Categorical Increases in PR Interval from Baseline
Increases in PR interval values from baseline >25% to a PR >200 msec.
Measured: Day -1 (baseline) and Days 1, 7, and 14
Number of Participants with Categorical Increases in QRS Interval from Baseline
Increases in QRS interval from baseline >25% to a QRS >120 msec.
Measured: Day -1 (baseline) and Days 1, 7, and 14
Number of Participants with Categorical Decreases in HR from Baseline
Decreases in HR from baseline >25% to a HR <50 beats per minute (bpm).
Measured: Day -1 (baseline) and Days 1, 7, and 14
Change from Baseline in the Number of T-wave Morphology Findings
Measured: Day -1 (baseline) and Days 1, 7, and 14
Change from Baseline in the Number of U-waves
Measured: Day -1 (baseline) and Days 1, 7, and 14
Maximum Observed Plasma Concentration (Cmax) of Avacopan
Measured: Up to Day 14
Cmax of Avacopan Metabolite M1
Measured: Up to Day 14
Time of Cmax (Tmax) of Avacopan
Measured: Up to Day 14
Tmax of Avacopan Metabolite M1
Measured: Up to Day 14
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to 6 Hours (AUC0-6h) of Avacopan
Measured: Up to Hour 6 post-dose on Days 1, 7, and 14
AUC0-6h of Avacopan Metabolite M1
Measured: Up to Hour 6 post-dose on Days 1, 7, and 14
AUC From Time 0 to 12 Hours (AUC0-12h) of Avacopan
Measured: Up to Hour 12 post-dose on Days 1, 7, and 14
AUC0-12h of Avacopan Metabolite M1
Measured: Up to Hour 12 post-dose on Days 1, 7, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 Nov 2019
- Primary completion22 Jan 2020
- Study completion31 Mar 2020
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 ElectrocardiographyStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988034
- Sponsor's protocol ID
- CL014_168
- Status last verified
- Jul 2023
- First submitted
- 4 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Publications
Miao S, Staehr P, Tai E, Darpo B, Xue H, Armas D, Webster K, Oberoi RK. A phase I thorough QT/QTc study evaluating therapeutic and supratherapeutic doses of avacopan in healthy participants. Clin Transl Sci. 2024 Jul;17(7):e13878. doi: 10.1111/cts.13878.
PubMed 38973157
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 Multiple-dose, Randomized, Double-blind, Placebo-controlled, Active-Comparator, Parallel Study to Investigate the Effect of Avacopan at Therapeutic and Supratherapeutic Doses on the QT/QTc Interval in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05988034
- Acronym / sponsor ID
- CL014_168
- Conditions
- Electrocardiography
- Keywords
- Complement 5a receptor (C5aR), Anti-neutrophil cytoplasmic antibody-associated vasculitis, Complement, Vasculitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 14 Aug 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.
The primary objective of this study is to evaluate the effects of therapeutic and supratherapeutic doses of avacopan on the heart rate corrected QT interval, using Fridericia's formula (QTcF).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Avacopan | Experimental | Drug: Avacopan, Drug: Placebo for moxifloxacinParticipants will be randomized to receive multiple doses of avacopan orally twice daily (BID): 30 mg for 7 days and 100 mg for 7 days, for a total of 14 dosing days, and placebo for moxifloxacin on Days 1 and 15. |
| Cohort 2A: Moxifloxacin/Placebo | Active comparator | Drug: Moxifloxacin, Drug: Placebo for avacopan, Drug: Placebo for moxifloxacinParticipants will be randomized to receive moxifloxacin 400 mg orally on Day 1, placebo for avacopan BID on Days 1 to 14, and placebo for moxifloxacin on Day 15. |
| Cohort 2B: Placebo/Moxifloxacin | Active comparator | Drug: Moxifloxacin, Drug: Placebo for avacopan, Drug: Placebo for moxifloxacinParticipants will be randomized to receive placebo for moxifloxacin orally on Day 1, placebo for avacopan BID on Days 1 to 14, and moxifloxacin 400 mg orally on Day 15. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be able to verbalize understanding of consent form and able to provide written informed consent;
- Healthy male or female: No known history of a clinically significant medical diagnosis in the opinion of the Investigator and is not receiving prescription medication except birth control therapies; this includes but is not limited to no history of heart or lung disease (including latent tuberculosis), high blood pressure, history of any cardiac or endocrine disease (including thyroid disease and diabetes); appendectomy and cholecystectomy are allowed;
- Aged ≥18 and ≤60 years at the time of screening;
- Body mass index ≥18.0 and ≤30.0 kg/m^2, and body weight of ≥50 kg, at screening and Day -2;
- Non- or ex-smoker; an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration;
Key exclusion criteria (21 listed)
- An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second- or third-degree atrioventricular block, or one or more of the following: QRS interval >110 msec; QTcF >450 msec; PR interval >200 msec; HR <40 bpm; or any rhythm other than sinus rhythm that is interpreted an investigator to be clinically significant;
- History of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesemia. Participants will also be excluded if there is a family history of long QT syndrome or Brugada syndrome;
- A sustained supine systolic blood pressure >150 mm Hg or <90 mm Hg or a supine diastolic blood pressure >95 mm Hg or <50 mm Hg at screening or on Day -1. Blood pressure may be retested more than once in the supine position. The blood pressure abnormality is considered sustained if either the systolic or the diastolic pressure values are outside the stated limits after 3 assessments and the participant may not be randomized;
- A resting HR of <40 bpm or >100 bpm when vital signs are measured at screening or on Day -1;
- Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia;
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 |
|---|---|---|
| AvacopanAdministered orally. | Drug | Cohort 1: Avacopan |
| MoxifloxacinAdministered orally. | Drug | Cohort 2A: Moxifloxacin/Placebo, Cohort 2B: Placebo/Moxifloxacin |
| Placebo for avacopanAdministered orally. | Drug | Cohort 2A: Moxifloxacin/Placebo, Cohort 2B: Placebo/Moxifloxacin |
| Placebo for moxifloxacinAdministered orally. | Drug | Cohort 1: Avacopan, Cohort 2A: Moxifloxacin/Placebo, Cohort 2B: Placebo/Moxifloxacin |
Primary outcome
Change from Baseline in QTcF
Time frame: Day -1 (baseline) and up to Day 14
21 secondary outcomes
Change from Baseline in Heart Rate (HR)
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Change from Baseline in Time Between P and R Wave (PR Interval)
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Change from Baseline in Complex Between Q and S Wave (QRS Interval)
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Placebo-corrected Change from Baseline in HR
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Placebo-corrected Change from Baseline in QTcF
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Placebo-corrected Change from Baseline in PR Interval
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Placebo-corrected Change from Baseline in QRS Interval
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Number of Participants with Categorical Increases in QTcF from Baseline
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Number of Participants with Categorical Increases in PR Interval from Baseline
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Number of Participants with Categorical Increases in QRS Interval from Baseline
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Number of Participants with Categorical Decreases in HR from Baseline
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Change from Baseline in the Number of T-wave Morphology Findings
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Change from Baseline in the Number of U-waves
Time frame: Day -1 (baseline) and Days 1, 7, and 14
Maximum Observed Plasma Concentration (Cmax) of Avacopan
Time frame: Up to Day 14
Cmax of Avacopan Metabolite M1
Time frame: Up to Day 14
Time of Cmax (Tmax) of Avacopan
Time frame: Up to Day 14
Tmax of Avacopan Metabolite M1
Time frame: Up to Day 14
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to 6 Hours (AUC0-6h) of Avacopan
Time frame: Up to Hour 6 post-dose on Days 1, 7, and 14
AUC0-6h of Avacopan Metabolite M1
Time frame: Up to Hour 6 post-dose on Days 1, 7, and 14
AUC From Time 0 to 12 Hours (AUC0-12h) of Avacopan
Time frame: Up to Hour 12 post-dose on Days 1, 7, and 14
AUC0-12h of Avacopan Metabolite M1
Time frame: Up to Hour 12 post-dose on Days 1, 7, and 14
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 38973157Miao S, Staehr P, Tai E, Darpo B, Xue H, Armas D, Webster K, Oberoi RK. A phase I thorough QT/QTc study evaluating therapeutic and supratherapeutic doses of avacopan in healthy participants. Clin Transl Sci. 2024 Jul;17(7):e13878. doi: 10.1111/cts.13878.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
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 Avacopan and Moxifloxacin in people with Electrocardiography, run by Amgen 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 7 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 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 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?
Change from Baseline in QTcF (time frame: Day -1 (baseline) and up to Day 14). 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 NCT05988034, 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.