HealthyPhase 1NCT05541315

A Single Ascending Dose Study of JNJ-88260237 in Healthy Participants

A Phase 1 study testing JNJ-88260237 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety and tolerability of a single oral dose of JNJ-88260237 in healthy participants Read more about this study

Who is it for?: Ages 25 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: JNJ-88260237
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 14 Sep 2022to 9 May 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 25 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Otherwise, healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) evaluations performed at screening
Body mass index (BMI) within the range 18 to 30 kilogram/meter^2 (kg/m^2) (inclusive)
A female must be a) not of childbearing potential defined as postmenopausal or permanently sterile
A female must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 30 days after administration of study intervention
A male participant must agree not to donate sperm for the purpose of reproduction or plan to father a child during the study and for a minimum of 90 days after receiving study intervention

Who cannot join

History of liver (with the exception of Gilbert's syndrome or asymptomatic gallstones) or renal insufficiency (estimated glomerular filtration rate [eGFR] below 90 mL/minute at screening only); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Any history of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin)
Had major surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has any surgery planned during the time the participant is expected to participate in the study or within 4 weeks after study intervention administration
History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the study intervention(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed)
Any current active infections, including localized infections, or any recent history (within 4 weeks prior to administration of study intervention) of active infections, or a history of recurrent, severe, or chronic infections, or otherwise increased risk of infection

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: A Double-blind, Randomized, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-88260237 in Healthy Participants

The purpose of this study is to assess the safety and tolerability of a single oral dose of JNJ-88260237 in healthy participants

Conditions: Healthy
Being tested: JNJ-88260237, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JNJ-88260237Drug
JNJ-88260237 will be administered orally.
PlaceboDrug
Matching placebo will be administered orally.

Study groups in NCT05541315
Study group	Role	What they receive
JNJ-88260237	Experimental	Participants will be randomized into 6 cohorts to receive single oral dose of JNJ-88260237 on Day 1. The doses in each cohort (Cohorts 2 to 4 and 6) will be escalated based on the safety and pharmacokinetics (PK) data of the previous cohort. For Cohort 5, participants will receive a single-dose of JNJ-82260237 in fasted conditions and a single dose of JNJ-82260237 in fed conditions with dosing sequence determined by randomization. Receives: Drug: JNJ-88260237
Placebo	Placebo comparator	Participants in Cohorts 1 to 4 and 6 will receive single oral dose of matching placebo on Day 1. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohort 1 to 4 and Cohort 6: Number of Participants with Adverse Events (AEs)
Number of participants with AEs will be reported.
Measured: Up to Day 14
Cohort 5: Number of Participants with Adverse Events (AEs)
Number of participants with AEs will be reported.
Measured: Up to Day 24
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Measured: Up to Day 7
Cohort 5: Number of Participants with Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Measured: Up to Day 21
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Electrocardiogram (ECG)
Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.
Measured: Up to Day 7
Cohort 5: Number of Participants with Abnormalities in Electrocardiogram (ECG)
Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.
Measured: Up to Day 21
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters
Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.
Measured: Up to Day 7
Cohort 5: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters
Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.
Measured: Up to Day 21
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Physical Examinations
Number of participants with abnormalities in physical examinations will be reported.
Measured: Up to Day 7
Cohort 5: Number of Participants with Abnormalities in Physical Examinations
Number of participants with abnormalities in physical examinations will be reported.
Measured: Up to Day 21

Secondary outcomes (7)

Maximum Observed Whole Blood Concentration (Cmax) of JNJ-88260237
Cmax is defined as the maximum whole blood concentration of JNJ-88260237.
Measured: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Time to Reach the Maximum Whole Blood Concentration (Tmax) of JNJ-88260237
Tmax is defined as the time to reach the maximum whole blood concentration of JNJ-88260237.
Measured: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last]) of JNJ-88260237
AUC (0-Last) is defined as the area under the whole blood concentration versus time curve from time zero to time of the last measurable concentration of JNJ-88260237.
Measured: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Infinite Time (AUC [0-Infinity]) of JNJ-88260237
AUC (0-infinity) is defined as the area under the whole blood concentration versus time curve from time zero to infinite time of JNJ-88260237.
Measured: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Terminal Half-life (T1/2) of JNJ-88260237
T1/2 is defined as the terminal half-life of JNJ-88260237.
Measured: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Apparent Oral Whole Blood Clearance (CL/F) of JNJ-88260237
CL/F is defined as apparent oral whole blood clearance of JNJ-88260237.
Measured: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Apparent Volume of Distribution (Vz/F) of JNJ-88260237
Vz/F is defined as the apparent volume of distribution of JNJ-88260237.
Measured: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 20229 May 2023

First posted15 Sep 2022
Study start14 Sep 2022
Primary completion9 May 2023
Study completion9 May 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05541315
Sponsor's protocol ID: CR109227
Other IDs: 88260237CKD1001
Status last verified: Mar 2025
First submitted: 14 Sep 2022
Last updated: 30 Mar 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-88260237 in Healthy Participants
ClinicalTrials.gov ID: NCT05541315
Acronym / sponsor ID: CR109227
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 14 Sep 2022 (actual)
Primary completion: 9 May 2023 (actual)
Study completion: 9 May 2023 (actual)
First posted: 15 Sep 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 assess the safety and tolerability of a single oral dose of JNJ-88260237 in healthy participants

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
JNJ-88260237	Experimental	Drug: JNJ-88260237Participants will be randomized into 6 cohorts to receive single oral dose of JNJ-88260237 on Day 1. The doses in each cohort (Cohorts 2 to 4 and 6) will be escalated based on the safety and pharmacokinetics (PK) data of the previous cohort. For Cohort 5, participants will receive a single-dose of JNJ-82260237 in fasted conditions and a single dose of JNJ-82260237 in fed conditions with dosing sequence determined by randomization.
Placebo	Placebo comparator	Drug: PlaceboParticipants in Cohorts 1 to 4 and 6 will receive single oral dose of matching placebo on Day 1.

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Otherwise, healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) evaluations performed at screening
Body mass index (BMI) within the range 18 to 30 kilogram/meter^2 (kg/m^2) (inclusive)
A female must be a) not of childbearing potential defined as postmenopausal or permanently sterile
A female must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 30 days after administration of study intervention
A male participant must agree not to donate sperm for the purpose of reproduction or plan to father a child during the study and for a minimum of 90 days after receiving study intervention

Key exclusion criteria (5 listed)

History of liver (with the exception of Gilbert's syndrome or asymptomatic gallstones) or renal insufficiency (estimated glomerular filtration rate [eGFR] below 90 mL/minute at screening only); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Any history of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin)
Had major surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has any surgery planned during the time the participant is expected to participate in the study or within 4 weeks after study intervention administration
History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the study intervention(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed)
Any current active infections, including localized infections, or any recent history (within 4 weeks prior to administration of study intervention) of active infections, or a history of recurrent, severe, or chronic infections, or otherwise increased risk of infection

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-88260237JNJ-88260237 will be administered orally.	Drug	JNJ-88260237
PlaceboMatching placebo will be administered orally.	Drug	Placebo

Primary outcome

Cohort 1 to 4 and Cohort 6: Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 14
Number of participants with AEs will be reported.
Cohort 5: Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 24
Number of participants with AEs will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Vital Signs
Time frame: Up to Day 7
Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Cohort 5: Number of Participants with Abnormalities in Vital Signs
Time frame: Up to Day 21
Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Electrocardiogram (ECG)
Time frame: Up to Day 7
Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.
Cohort 5: Number of Participants with Abnormalities in Electrocardiogram (ECG)
Time frame: Up to Day 21
Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters
Time frame: Up to Day 7
Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.
Cohort 5: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters
Time frame: Up to Day 21
Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Physical Examinations
Time frame: Up to Day 7
Number of participants with abnormalities in physical examinations will be reported.
Cohort 5: Number of Participants with Abnormalities in Physical Examinations
Time frame: Up to Day 21
Number of participants with abnormalities in physical examinations will be reported.

7 secondary outcomes

Maximum Observed Whole Blood Concentration (Cmax) of JNJ-88260237
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Time to Reach the Maximum Whole Blood Concentration (Tmax) of JNJ-88260237
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last]) of JNJ-88260237
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Infinite Time (AUC [0-Infinity]) of JNJ-88260237
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Terminal Half-life (T1/2) of JNJ-88260237
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Apparent Oral Whole Blood Clearance (CL/F) of JNJ-88260237
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Apparent Volume of Distribution (Vz/F) of JNJ-88260237
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21

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 30 Mar 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-88260237 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 30 Mar 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. 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 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?

Cohort 1 to 4 and Cohort 6: Number of Participants with Adverse Events (AEs) (time frame: Up to Day 14). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05541315.

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 30 Mar 2025.