HealthyPhase 1NCT04844463
A Study of JNJ-68179280 in Healthy Participants
A Phase 1 study testing JNJ-68179280 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of JNJ-68179280 compared with placebo after administration of single ascending oral doses of JNJ-68179280 administered to healthy participants (Part 1), multiple ascending oral doses of JNJ-68179280, administered to healthy participants once daily… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-68179280
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to 13 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel (excluding liver enzymes) including hematology, blood coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Have the following pre study intervention clinical laboratory values during screening and check-in to the unit (Day -2 or Day -1): a. aspartate transaminase (AST) less than or equal to (<=) upper limit of normal (ULN), b. alanine aminotransferase (ALT) <= ULN, c. bilirubin <= ULN, d. alkaline phosphatase <= ULN, e. gamma-glutamyl transpeptidase (GGTP) <= ULN, f. albumin greater than or equal to (>=) lower limit of normal (LLN)
- A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at check-in to the unit on Day -2 or Day -1
- Must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (example: nicotine patch, vaping, hookah) for 3 months prior to screening
Who cannot join
- History of liver or renal insufficiency significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- History of malignancy before screening (exceptions are squamous or basal cell carcinomas of the skin and carcinoma in situ of the cervix as long as they are considered cured with minimal risk of recurrence)
- Has an active, acute or chronic infection
- Has taken any disallowed therapies, concomitant therapy before the planned first dose of study intervention
- Has a positive urine drug screen and/or alcohol breath test during screening or on Day 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-68179280 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability of JNJ-68179280 compared with placebo after administration of single ascending oral doses of JNJ-68179280 administered to healthy participants (Part 1), multiple ascending oral doses of JNJ-68179280, administered to healthy participants once daily (Cohorts 1 through 4) or twice daily (Cohort 5) over 14 consecutive days (Part 2) and multiple ascending oral doses of an alternative JNJ-68179280 formulation, administered to healthy participants once daily over 14 consecutive days (Part 3 if conducted).
- Conditions
- Healthy
- Being tested
- JNJ-68179280, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-68179280Drug
JNJ-68179280 will be administered as an oral capsule.
PlaceboOther
Matching placebo will be administered as an oral capsule.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Participants will receive a single ascending oral dose of JNJ-68179280 or placebo capsules under fasted condition (Cohort 1, 2 and 5) and under fasted-fed condition (either Cohort 3 or 4) on Day 1. In 1 of the study cohorts 3 or 4, participants will also receive study intervention on Day 8 under fed condition. One additional optional Cohort 6 may be dosed to assess the safety and pharmacokinetics (PK) of an alternate dose of formulation A under fasted condition. Receives: Drug: JNJ-68179280; Other: Placebo |
| Part 2: Multiple Ascending Dose (MAD) | Experimental | Participants will receive multiple ascending oral doses of JNJ-68179280 or placebo capsules once daily in Cohort 1 through 4 or twice daily in Cohort 5 (optional) on Days 1 through 14 under fasted or fed condition. Receives: Drug: JNJ-68179280; Other: Placebo |
| Part 3: Multiple Dose Alternative Formulation (Optional) | Experimental | Participants will receive multiple oral doses of an alternative JNJ-68179280 formulation once daily in Cohort 1 and Cohort 2 (optional) on Days 1 through 14 under fasted or fed condition. Doses in Part 3 will depend on the safety, tolerability, PK and pharmacodynamics data from Part 1 and Part 2. Receives: Drug: JNJ-68179280 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Measured: Up to 35 days
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to 35 days
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Number of participants with clinically significant abnormalities in vital signs (including temperature [oral or tympanic], pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Measured: Up to 35 days
Number of Participants with Clinically Significant Abnormalities in Physical Examination
Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) will be reported.
Measured: Up to 35 days
Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests
Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported.
Measured: Up to 35 days
Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)
Number of participants with clinically significant abnormalities in ECGs will be reported.
Measured: Up to 28 days
Secondary outcomes (19)
Part 1, 2 and 3: Plasma Concentration of JNJ-68179280
Plasma concentration of JNJ-68179280 will be reported.
Measured: Up to 19 days
Part 1, 2 and 3: Urine Concentration of JNJ-68179280
Urine samples will be analyzed to determine the concentration of JNJ-68179280.
Measured: Up to 19 days
Part 1, 2 and 3: Stool Concentration of JNJ-68179280
Stool samples will be analyzed to determine the concentration of JNJ-68179280.
Measured: Up to 16 days
Part 1: Plasma Concentration of JNJ-68179280 Under Fasted Condition
Plasma concentration of JNJ-68179280 under fasted condition will be reported.
Measured: Up to Day 6
Part 1: Plasma Concentration of JNJ-68179280 Under Fed Condition
Plasma concentration of JNJ-68179280 under fed condition will be reported.
Measured: Up to 13 days
Part 1: Stool Concentration of JNJ-68179280 Under Fasted Condition
Stool samples will be analyzed to determine the concentration of JNJ-68179280 under fasted condition.
Measured: Up to Day 6
Part 1: Stool Concentration of JNJ-68179280 Under Fed Condition
Stool samples will be analyzed to determine the concentration of JNJ-68179280 under fed conditions.
Measured: Up to 13 days
Part 1: Number of Participants with TEAEs Under Fasted Condition
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Measured: Up to 16 days
Part 1: Number of Participants with TEAEs Under Fed Condition
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Measured: Up to 23 days
Part 1: Number of Participants with SAEs Under Fasted Condition
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to 16 days
Part 1: Number of Participants with SAEs Under Fed Condition
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fasted Condition
Number of participants with clinically significant abnormalities in vital signs (including temperature [oral or tympanic], pulse/heart rate, respiratory rate, and blood pressure) under fasted condition will be reported.
Measured: Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fed Condition
Number of participants with clinically significant abnormalities in vital signs (including temperature [oral or tympanic], pulse/heart rate, respiratory rate, and blood pressure) under fed condition will be reported.
Measured: Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fasted Condition
Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) under fasted condition will be reported.
Measured: Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fed Condition
Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) under fed condition will be reported.
Measured: Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fasted Condition
Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) under fasted condition will be reported.
Measured: Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fed Condition
Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) under fed condition will be reported.
Measured: Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fasted Condition
Number of participants with clinically significant abnormalities in ECGs under fasted condition will be reported.
Measured: Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fed Condition
Number of participants with clinically significant abnormalities in ECGs under fed condition will be reported.
Measured: Up to 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start26 May 2021
- Primary completion7 Mar 2023
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844463
- Sponsor's protocol ID
- CR108989
- Other IDs
- 68179280IBD1001
- Status last verified
- Jan 2025
- First submitted
- 13 Apr 2021
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-68179280 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04844463
- Acronym / sponsor ID
- CR108989
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 May 2021 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 14 Apr 2021 (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 and tolerability of JNJ-68179280 compared with placebo after administration of single ascending oral doses of JNJ-68179280 administered to healthy participants (Part 1), multiple ascending oral doses of JNJ-68179280, administered to healthy participants once daily (Cohorts 1 through 4) or twice daily (Cohort 5) over 14 consecutive days (Part 2) and multiple ascending oral doses of an alternative JNJ-68179280 formulation, administered to healthy participants once daily over 14 consecutive days (Part 3 if conducted).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Drug: JNJ-68179280, Other: PlaceboParticipants will receive a single ascending oral dose of JNJ-68179280 or placebo capsules under fasted condition (Cohort 1, 2 and 5) and under fasted-fed condition (either Cohort 3 or 4) on Day 1. In 1 of the study cohorts 3 or 4, participants will also receive study intervention on Day 8 under fed condition. One additional optional Cohort 6 may be dosed to assess the safety and pharmacokinetics (PK) of an alternate dose of formulation A under fasted condition. |
| Part 2: Multiple Ascending Dose (MAD) | Experimental | Drug: JNJ-68179280, Other: PlaceboParticipants will receive multiple ascending oral doses of JNJ-68179280 or placebo capsules once daily in Cohort 1 through 4 or twice daily in Cohort 5 (optional) on Days 1 through 14 under fasted or fed condition. |
| Part 3: Multiple Dose Alternative Formulation (Optional) | Experimental | Drug: JNJ-68179280Participants will receive multiple oral doses of an alternative JNJ-68179280 formulation once daily in Cohort 1 and Cohort 2 (optional) on Days 1 through 14 under fasted or fed condition. Doses in Part 3 will depend on the safety, tolerability, PK and pharmacodynamics data from Part 1 and Part 2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel (excluding liver enzymes) including hematology, blood coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Have the following pre study intervention clinical laboratory values during screening and check-in to the unit (Day -2 or Day -1): a. aspartate transaminase (AST) less than or equal to (<=) upper limit of normal (ULN), b. alanine aminotransferase (ALT) <= ULN, c. bilirubin <= ULN, d. alkaline phosphatase <= ULN, e. gamma-glutamyl transpeptidase (GGTP) <= ULN, f. albumin greater than or equal to (>=) lower limit of normal (LLN)
- A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at check-in to the unit on Day -2 or Day -1
- Must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (example: nicotine patch, vaping, hookah) for 3 months prior to screening
Key exclusion criteria (5 listed)
- History of liver or renal insufficiency significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- History of malignancy before screening (exceptions are squamous or basal cell carcinomas of the skin and carcinoma in situ of the cervix as long as they are considered cured with minimal risk of recurrence)
- Has an active, acute or chronic infection
- Has taken any disallowed therapies, concomitant therapy before the planned first dose of study intervention
- Has a positive urine drug screen and/or alcohol breath test during screening or on Day 2
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 |
|---|---|---|
| JNJ-68179280JNJ-68179280 will be administered as an oral capsule. | Drug | Part 1: Single Ascending Dose (SAD), Part 2: Multiple Ascending Dose (MAD), Part 3: Multiple Dose Alternative Formulation (Optional) |
| PlaceboMatching placebo will be administered as an oral capsule. | Other | Part 1: Single Ascending Dose (SAD), Part 2: Multiple Ascending Dose (MAD) |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 35 days
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Time frame: Up to 35 days
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time frame: Up to 35 days
Number of participants with clinically significant abnormalities in vital signs (including temperature [oral or tympanic], pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Number of Participants with Clinically Significant Abnormalities in Physical Examination
Time frame: Up to 35 days
Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) will be reported.
Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests
Time frame: Up to 35 days
Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported.
Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)
Time frame: Up to 28 days
Number of participants with clinically significant abnormalities in ECGs will be reported.
19 secondary outcomes
Part 1, 2 and 3: Plasma Concentration of JNJ-68179280
Time frame: Up to 19 days
Part 1, 2 and 3: Urine Concentration of JNJ-68179280
Time frame: Up to 19 days
Part 1, 2 and 3: Stool Concentration of JNJ-68179280
Time frame: Up to 16 days
Part 1: Plasma Concentration of JNJ-68179280 Under Fasted Condition
Time frame: Up to Day 6
Part 1: Plasma Concentration of JNJ-68179280 Under Fed Condition
Time frame: Up to 13 days
Part 1: Stool Concentration of JNJ-68179280 Under Fasted Condition
Time frame: Up to Day 6
Part 1: Stool Concentration of JNJ-68179280 Under Fed Condition
Time frame: Up to 13 days
Part 1: Number of Participants with TEAEs Under Fasted Condition
Time frame: Up to 16 days
Part 1: Number of Participants with TEAEs Under Fed Condition
Time frame: Up to 23 days
Part 1: Number of Participants with SAEs Under Fasted Condition
Time frame: Up to 16 days
Part 1: Number of Participants with SAEs Under Fed Condition
Time frame: Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fasted Condition
Time frame: Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fed Condition
Time frame: Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fasted Condition
Time frame: Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fed Condition
Time frame: Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fasted Condition
Time frame: Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fed Condition
Time frame: Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fasted Condition
Time frame: Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fed Condition
Time frame: Up to 23 days
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 3 Feb 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 JNJ-68179280 in people with Healthy, run by Janssen Research & Development, LLC 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 5 inclusion and 5 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 35 days). The study lists 6 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 3 Feb 2025.