COVID-19Phase 1NCT06274853
GS-441524 for COVID-19 SAD, FE, and MAD Study in Healthy Subjects
A Phase 1 study testing GS-441524 in people with COVID-19, run by National Center for Advancing Translational Sciences (NCATS).
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of GS-441524 in healthy subjects. The main questions to answer are: 1) What dosage of GS-441524 is required for adequate therapeutic plasma levels? 2) Does fed or fasted state produce variability in plasma levels? 3) How is… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- GS-441524
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, be able to comply with protocol requirements, rules and regulations of study site, and be likely to complete all the study interventions.
- Must be considered a healthy male or healthy female of nonchildbearing potential.
- Women of nonchildbearing potential are considered women who:
- Do not have a uterus, or
- Are surgically sterile (for example: has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation; should be verified by medical documentation), or
- Have permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries, or
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- Are postmenopausal as defined by 12 months or more of spontaneous amenorrhea as confirmed by a follicle-stimulating hormone (FSH) level >30 mIU/mL.
- Between 18 and 55 years of age, inclusive.
- Body mass index (BMI) within 18.0 to 32.0 kg/m2, inclusive.
- Minimum weight of at least 50.0 kg at screening.
- Male subjects who are sexually active with female partners of childbearing potential must use, with their partner, a condom plus an approved method of effective contraception from the time of screening until 90 days after the last dose of investigational medicinal product (IMP). Additionally, male subjects must agree to not donate sperm during the study and for at least 90 days from the last dose of IMP. Effective methods of contraception are:
- Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
- Progestogen-only hormonal contraception (oral, injectable/implantable, or intrauterine hormone-releasing system)
- Implantable intrauterine device
- Surgical sterilization (for example, vasectomy or bilateral tubal ligation; should be verified by medical documentation)
- Male condom with spermicidal gel/foam or with female cap or diaphragm (double barrier)
- Must have normal renal function (estimated glomerular filtration rate [eGFR] >75 mL/min/1.73 m2, as calculated by the CKD-EPI 2021 creatinine formula).
Who cannot join
- Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder as judged by an Investigator.
- Have clinically significant abnormal biochemistry, hematology, or urinalysis results as judged by an Investigator.
- Have disorders that may interfere with drug absorption, distribution, metabolism, and excretion processes.
- Positive test results for human immunodeficiency virus (HIV)-1/HIV-2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody.
- Serious cardiac illness or other medical condition including, but not limited to:
- Uncontrolled arrhythmias
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- History of congestive heart failure
- Corrected QT value with Fridericia's formula (QTcF) >450 msec for males and >470 msec for females or history of prolonged QT syndrome
- Have a blood pressure reading outside of the following range: systolic blood pressure <86 mmHg or >149 mmHg and diastolic blood pressure <50 mmHg or >94 mmHg
- History of pancreatitis and history of hepatic or biliary disease, including those with known history/diagnosis of Gilbert's syndrome. Subjects with gall bladder removal <90 days prior to screening.
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit=12 ounces of beer, 1.5 ounces of spirit, or 5 ounces of wine) within 12 months prior to screening.
- Positive test result for alcohol and/or drugs of abuse at screening or prior to the first IMP administration.
- Current smokers and those who have smoked within 90 days prior to the first IMP administration. Current users of e cigarettes and nicotine replacement products, and those who have used these products within 90 days prior to the first IMP administration.
- Concurrent treatment or treatment with an investigational drug within 30 days prior to the first dose of IMP.
- Blood donation of approximately 500 mL within 56 days or plasma donation within 7 days of screening.
- Subjects who are taking, or have taken, any prescribed or over-the-counter drugs (other than a maximum of 2 g per day of acetaminophen, hormone replacement therapy, hormonal contraception) or herbal remedies in the 14 days before randomization. Exceptions may apply on a case-by-case basis if considered not to interfere with the objectives of the study, as agreed by the Investigator and Sponsor's Medical Monitor.
- Known allergy or intolerance to remdesivir.
- Any condition that, in the opinion of an Investigator, would interfere with evaluation or interpretation of subject safety or study results.
- Affiliated with, or a family member of, site staff directly involved in the study, or anyone with a financial interest in the outcome of the study.
- Subjects who are unable, in the opinion of an Investigator, to comply fully with the study requirements.
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose, Multiple Ascending Dose, and Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-441524 in Healthy Subjects
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of GS-441524 in healthy subjects. The main questions to answer are: 1) What dosage of GS-441524 is required for adequate therapeutic plasma levels? 2) Does fed or fasted state produce variability in plasma levels? 3) How is GS-441524 eliminated from the body.
Participants will receive varying levels of GS-441524 or placebo to evaluate AEs and plasma levels.
Read the detailed description
This study will consist of 3 parts: an a single ascending dose (SAD) part, an food effect (FE) part, and an multiple ascending dose (MAD) part.
- SAD Part This will be a randomized, double-blind, placebo-controlled single-dose study part of GS-441524 in healthy human subjects. The SAD part will consist of at least 4 cohorts and up to 5 cohorts. Subjects will be randomized into one dose cohort and receive either active drug or placebo. Within each cohort, 6 subjects will receive GS-441524 and 2 subjects will receive placebo. The proposed doses are: 100 mg, 300 mg, 600 mg, and 1000 mg.
A sentinel group of 2 subjects will be randomized to active drug or placebo (1 active; 1 placebo) and will be dosed ahead of the rest of each cohort. There will be a minimum of 48 hours between dosing of the 2 sentinel subjects and the remainder of the cohort. A review of sentinel group safety data after dosing will be completed before dose administration will continue in the remaining 6 subjects (5 active; 1 placebo) of each cohort. An optional fifth dose level may be added based on safety and PK data from the first 4 cohorts.
- FE Part This will be a randomized, balanced, single-dose, two-treatment (fed vs fasting), two-period, two sequence crossover study part in healthy human subjects using a clinically relevant dose of GS-441524 (a dose that may achieve an anticipated efficacious exposure of 2 µM3). The dose will be selected from the SAD part and will be given once under fasting conditions and once under fed conditions (after completion of a standard FDA defined high-fat breakfast) in 1 cohort of 6 subjects.
- MAD Part This will be a randomized, double-blind, placebo-controlled, repeat-dose study part of GS-441524 in healthy human subjects. There will be up to 3 dose cohorts. Subjects will be randomized into one dose cohort to receive either active drug or placebo. Within each cohort, 6 subjects will receive GS-441524 and 2 subjects will receive placebo. Subjects will be administered GS-441524 or placebo twice daily for 5 days (Days 1 to 5) and only a morning dose on Day 6.
- Conditions
- COVID-19
- Being tested
- GS-441524, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-441524Drug
Also called (2R,3R,4S,5R)-2-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-carbonitrile
Oral GS-441524 capsules
PlaceboDrug
Also called Pregelatinized starch, colloidal silicon dioxide, magnesium stearate
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | A single oral dose of 100 mg GS-441524 under fasted conditions Receives: Drug: GS-441524 |
| SAD Placebo | Placebo comparator | Matching Placebo under fasted conditions Receives: Drug: Placebo |
| SAD Cohort 2 | Experimental | A single oral dose of 300 mg GS-441524 Receives: Drug: GS-441524 |
| SAD Cohort 3 | Experimental | A single oral dose of 600 mg GS-441524 Receives: Drug: GS-441524 |
| SAD Cohort 4 | Experimental | A single oral dose of 1000 mg GS-441524 Receives: Drug: GS-441524 |
| SAD Cohort 5 | Experimental | Optional Cohort - dose TBD Receives: Drug: GS-441524 |
| Food Effect | Experimental | Randomized, balanced, single-dose, two-treatment (fed vs fasting), two-period, two sequence crossover study part in healthy human subjects Treatment A: a single oral dose of TBD mg GS-441524 under fasted conditions Treatment B: a single oral dose of TBD mg GS-441524 under fed conditions Receives: Drug: GS-441524 |
| MAD Cohort 1 | Experimental | Multiple oral doses of TBD mg GS-441524under fasted or fed conditions twice daily for 5 days (Days 1 to 5) and only a morning dose on Day 6 Receives: Drug: GS-441524 |
| MAD Cohort 2 | Experimental | Multiple oral doses of TBD mg GS-441524under fasted or fed conditions twice daily for 5 days (Days 1 to 5) and only a morning dose on Day 6 Receives: Drug: GS-441524 |
| MAD Cohort 3 | Experimental | Multiple oral doses of TBD mg GS-441524under fasted or fed conditions twice daily for 5 days (Days 1 to 5) and only a morning dose on Day 6 Receives: Drug: GS-441524 |
| MAD Placebo | Placebo comparator | Matching Placebo under fasted or fed conditions Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs)
Number of incidences
Measured: 10 days
Blood Pressure in mm/Hg
Changes from baseline
Measured: 10 days
Pulse in beats/min
Changes from baseline
Measured: 10 days
Respiratory Rate in breaths per minute
Changes from baseline
Measured: 10 days
Body Temperature in degrees
Changes from baseline
Measured: 10 days
Electrocardiogram (ECG) as measured by PR interval
Changes from baseline
Measured: 10 days
Electrocardiogram (ECG) as measured by QT interval
Changes from baseline
Measured: 10 days
Electrocardiogram (ECG) as measured by QT corrected (Fridericia's)
Changes from baseline
Measured: 10 days
Secondary outcomes (16)
Plasma PK Parameter C-Max
Maximum observed plasma concentration
Measured: 10 days
Plasma PK Parameter t-max
Time to attain maximum observed plasma concentration
Measured: 10 days
Plasma PK Parameter t-lag
Time before the first concentration above the lower limit of quantitation
Measured: 10 days
Plasma PK Parameter AUC 0-last
Area under the plasma concentration time curve from time zero to the last quantifiable time point
Measured: 6 days
Plasma PK Parameter AUC 0-inf
Area under the plasma concentration time curve from time 0 to infinity
Measured: 6 days
Plasma PK Parameter t 1/2
Terminal elimination half-life
Measured: 10 days
Plasma PK Parameter CL/F
Apparent oral clearance
Measured: 10 days
Plasma PK Parameter Vz/F
Apparent volume of distribution
Measured: 10 days
Urine PK Parameter Ae urine
Cumulative amount of study drug excreted in urine
Measured: 10 days
Urine PK Parameter Fe urine
Fraction of the dose administered excreted (unchanged in urine)
Measured: 10 days
Urine PK Parameter CL R
Renal clearance
Measured: 10 days
Plasma PK Parameter C trough
Trough Plasma concentration
Measured: 10 days
Plasma PK Parameter AUC 0-tau
Area under the plasma concentration time curve over a dosing interval tau
Measured: 10 days
Plasma PK Parameter CL/F ss
Apparent oral clearance at steady state
Measured: 10 days
Plasma PK Parameter Vz/F ss
Apparent volume of distribution at steady state
Measured: 10 days
Plasma PK Parameter R ac
Accumulation ration, based on Auc 0-tau of day 6 versus day1
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start15 Jun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Operational Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Advancing Translational Sciences (NCATS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Leidos Biomedical Research, Inc., ICON plc
- Responsible party
- Sponsor
- Investigators
- Philip E Sanderson, PhD, Study director, NCATS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274853
- Sponsor's protocol ID
- 170327-0001
- Other IDs
- 6830/0003
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2024
- Last updated
- 14 Feb 2025
- 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 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose, Multiple Ascending Dose, and Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-441524 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06274853
- Acronym / sponsor ID
- 170327-0001
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Operational Reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Center for Advancing Translational Sciences (NCATS)US National Institutes of Health
- Collaborators
- Leidos Biomedical Research, Inc., ICON plc
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Feb 2024 (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 goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of GS-441524 in healthy subjects. The main questions to answer are: 1) What dosage of GS-441524 is required for adequate therapeutic plasma levels? 2) Does fed or fasted state produce variability in plasma levels? 3) How is GS-441524 eliminated from the body.
Participants will receive varying levels of GS-441524 or placebo to evaluate AEs and plasma levels.
Detailed description
This study will consist of 3 parts: an a single ascending dose (SAD) part, an food effect (FE) part, and an multiple ascending dose (MAD) part.
- SAD Part This will be a randomized, double-blind, placebo-controlled single-dose study part of GS-441524 in healthy human subjects. The SAD part will consist of at least 4 cohorts and up to 5 cohorts. Subjects will be randomized into one dose cohort and receive either active drug or placebo. Within each cohort, 6 subjects will receive GS-441524 and 2 subjects will receive placebo. The proposed doses are: 100 mg, 300 mg, 600 mg, and 1000 mg.
A sentinel group of 2 subjects will be randomized to active drug or placebo (1 active; 1 placebo) and will be dosed ahead of the rest of each cohort. There will be a minimum of 48 hours between dosing of the 2 sentinel subjects and the remainder of the cohort. A review of sentinel group safety data after dosing will be completed before dose administration will continue in the remaining 6 subjects (5 active; 1 placebo) of each cohort. An optional fifth dose level may be added based on safety and PK data from the first 4 cohorts.
- FE Part This will be a randomized, balanced, single-dose, two-treatment (fed vs fasting), two-period, two sequence crossover study part in healthy human subjects using a clinically relevant dose of GS-441524 (a dose that may achieve an anticipated efficacious exposure of 2 µM3). The dose will be selected from the SAD part and will be given once under fasting conditions and once under fed conditions (after completion of a standard FDA defined high-fat breakfast) in 1 cohort of 6 subjects.
- MAD Part This will be a randomized, double-blind, placebo-controlled, repeat-dose study part of GS-441524 in healthy human subjects. There will be up to 3 dose cohorts. Subjects will be randomized into one dose cohort to receive either active drug or placebo. Within each cohort, 6 subjects will receive GS-441524 and 2 subjects will receive placebo. Subjects will be administered GS-441524 or placebo twice daily for 5 days (Days 1 to 5) and only a morning dose on Day 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1 | Experimental | Drug: GS-441524A single oral dose of 100 mg GS-441524 under fasted conditions |
| SAD Placebo | Placebo comparator | Drug: PlaceboMatching Placebo under fasted conditions |
| SAD Cohort 2 | Experimental | Drug: GS-441524A single oral dose of 300 mg GS-441524 |
| SAD Cohort 3 | Experimental | Drug: GS-441524A single oral dose of 600 mg GS-441524 |
| SAD Cohort 4 | Experimental | Drug: GS-441524A single oral dose of 1000 mg GS-441524 |
| SAD Cohort 5 | Experimental | Drug: GS-441524Optional Cohort - dose TBD |
| Food Effect | Experimental | Drug: GS-441524Randomized, balanced, single-dose, two-treatment (fed vs fasting), two-period, two sequence crossover study part in healthy human subjects Treatment A: a single oral dose of TBD mg GS-441524 under fasted conditions Treatment B: a single oral dose of TBD mg GS-441524 under fed conditions |
| MAD Cohort 1 | Experimental | Drug: GS-441524Multiple oral doses of TBD mg GS-441524under fasted or fed conditions twice daily for 5 days (Days 1 to 5) and only a morning dose on Day 6 |
| MAD Cohort 2 | Experimental | Drug: GS-441524Multiple oral doses of TBD mg GS-441524under fasted or fed conditions twice daily for 5 days (Days 1 to 5) and only a morning dose on Day 6 |
| MAD Cohort 3 | Experimental | Drug: GS-441524Multiple oral doses of TBD mg GS-441524under fasted or fed conditions twice daily for 5 days (Days 1 to 5) and only a morning dose on Day 6 |
| MAD Placebo | Placebo comparator | Drug: PlaceboMatching Placebo under fasted or fed conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Must be able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, be able to comply with protocol requirements, rules and regulations of study site, and be likely to complete all the study interventions.
- Must be considered a healthy male or healthy female of nonchildbearing potential.
- Women of nonchildbearing potential are considered women who:
- Between 18 and 55 years of age, inclusive.
- Body mass index (BMI) within 18.0 to 32.0 kg/m2, inclusive.
Key exclusion criteria (20 listed)
- Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder as judged by an Investigator.
- Have clinically significant abnormal biochemistry, hematology, or urinalysis results as judged by an Investigator.
- Have disorders that may interfere with drug absorption, distribution, metabolism, and excretion processes.
- Positive test results for human immunodeficiency virus (HIV)-1/HIV-2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody.
- Serious cardiac illness or other medical condition including, but not limited to:
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 |
|---|---|---|
| GS-441524Also: (2R,3R,4S,5R)-2-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-carbonitrileOral GS-441524 capsules | Drug | Food Effect, MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4, SAD Cohort 5 |
| PlaceboAlso: Pregelatinized starch, colloidal silicon dioxide, magnesium stearatePlacebo capsules | Drug | MAD Placebo, SAD Placebo |
Primary outcome
Treatment-emergent adverse events (TEAEs)
Time frame: 10 days
Number of incidences
Blood Pressure in mm/Hg
Time frame: 10 days
Changes from baseline
Pulse in beats/min
Time frame: 10 days
Changes from baseline
Respiratory Rate in breaths per minute
Time frame: 10 days
Changes from baseline
Body Temperature in degrees
Time frame: 10 days
Changes from baseline
Electrocardiogram (ECG) as measured by PR interval
Time frame: 10 days
Changes from baseline
Electrocardiogram (ECG) as measured by QT interval
Time frame: 10 days
Changes from baseline
Electrocardiogram (ECG) as measured by QT corrected (Fridericia's)
Time frame: 10 days
Changes from baseline
16 secondary outcomes
Plasma PK Parameter C-Max
Time frame: 10 days
Plasma PK Parameter t-max
Time frame: 10 days
Plasma PK Parameter t-lag
Time frame: 10 days
Plasma PK Parameter AUC 0-last
Time frame: 6 days
Plasma PK Parameter AUC 0-inf
Time frame: 6 days
Plasma PK Parameter t 1/2
Time frame: 10 days
Plasma PK Parameter CL/F
Time frame: 10 days
Plasma PK Parameter Vz/F
Time frame: 10 days
Urine PK Parameter Ae urine
Time frame: 10 days
Urine PK Parameter Fe urine
Time frame: 10 days
Urine PK Parameter CL R
Time frame: 10 days
Plasma PK Parameter C trough
Time frame: 10 days
Plasma PK Parameter AUC 0-tau
Time frame: 10 days
Plasma PK Parameter CL/F ss
Time frame: 10 days
Plasma PK Parameter Vz/F ss
Time frame: 10 days
Plasma PK Parameter R ac
Time frame: 10 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- 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.
Philip E Sanderson, PhD study director
NCATS
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-441524 in people with COVID-19, run by National Center for Advancing Translational Sciences (NCATS).
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 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Treatment-emergent adverse events (TEAEs) (time frame: 10 days). The study lists 8 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 14 Feb 2025.