JNJ-88260237 for Healthy Volunteers

Overseen By Study Contact

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Disqualifiers: Liver, Renal, Cardiac, Malignancy, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of a new oral drug, JNJ-88260237, in healthy individuals. Participants receive either the drug or a placebo (a harmless pill with no active ingredient) to compare effects. The study aims to understand how the body processes the drug and determine its safety for future use. This trial suits healthy individuals without major medical conditions who are willing to follow specific guidelines about donating eggs or sperm.

As a Phase 1 trial, participants will be among the first to receive this new treatment, contributing to essential research on its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it might imply that you should not be on any regular medication. Please check with the study coordinators for confirmation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that JNJ-88260237 is being tested for safety as a single dose in healthy individuals. As this is an early-stage study, limited information is available about its safety. However, this phase focuses on safety and tolerability, so researchers closely monitor for any side effects or adverse reactions.

In studies like this, participants typically start with a low dose. If participants tolerate the low dose well, researchers may increase the dose for new participants. This careful approach helps ensure that any potential risks are quickly identified and minimized. Overall, joining this type of study contributes to an important process to ensure a new treatment's safety for future use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JNJ-88260237 because it presents a new approach to treatment through its escalating dosing strategy based on safety and pharmacokinetics data. Unlike traditional treatments that might stick to a fixed dose, this tailored approach allows for adjustments that maximize efficacy while minimizing side effects. Additionally, the investigation into the effects of the drug under both fasted and fed conditions offers a comprehensive understanding of its behavior in the body, which could lead to more flexible dosing schedules for patients. This adaptability and thoroughness could set JNJ-88260237 apart from existing options, potentially offering a more personalized and effective treatment path.

What evidence suggests that JNJ-88260237 could be effective?

Research shows that JNJ-88260237 is being tested in this trial to determine its safety and tolerability in healthy individuals. Participants will be randomized to receive either JNJ-88260237 or a placebo. The study examines how the body processes the drug and its initial effects. As this is a new treatment, limited information exists on its efficacy for specific illnesses. However, the drug's mechanism suggests potential future benefits, depending on the body's response in these trials. Early results from these studies are crucial in deciding whether further research is warranted. ^{1 2 3 5 6}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Your body mass index (BMI) falls between 18 and 30 kg/m^2.

Otherwise, healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) evaluations performed at screening

Exclusion Criteria

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)

You have had cancer before, except for certain types of skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of JNJ-88260237 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics after treatment

Up to 24 days

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-88260237
• Placebo

How Is the Trial Designed?

Group I: JNJ-88260237 Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

Participants in Cohorts 1 to 4 and 6 will receive single oral dose of matching placebo on Day 1.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05541315

A Single Ascending Dose Study of JNJ-88260237 in ... The purpose of this study is to assess the safety and tolerability of a single oral dose of JNJ-88260237 in healthy participants. Official Title.

2. synapse.patsnap.com synapse.patsnap.com/drug/4175e612386b44299facd56a430ccbec

JNJ-88260237 - Drug Targets, Indications, Patents A double-blind, randomized, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JNJ-88260237 in healthy ...

3. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-8-2022-96b06

A Single Ascending Dose Study of JNJ-88260237 in ... This trial is testing a new drug called JNJ-88260237 to see if it is safe and well-tolerated when taken by healthy people in a single dose.

4. ctv.veeva.com ctv.veeva.com/study/a-single-ascending-dose-study-of-jnj-88260237-in-healthy-participants

A Single Ascending Dose Study of JNJ-88260237 in Healthy ... The purpose of this study is to assess the safety and tolerability of a single oral dose of JNJ-88260237 in healthy participants.

5. investor.jnj.com investor.jnj.com/pipeline/development-pipeline/default.aspx

Development pipeline - JNJ Investor Relations Investor Links. Investor news · Pipeline · Financials - Quarterly results · Events & presentations · Stock info · Governance · Resources - Investor FAQs ...

6. adisinsight.springer.com adisinsight.springer.com/drugs/800070188

JNJ 88260237 - AdisInsight - Springer JNJ 88260237 is an orally administered drug is being developed by Janssen Research & Development for an unspecified indication Clinical development is.