40 Participants Needed

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

SC
Overseen ByStudy Contact
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Janssen Research & Development, LLC

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Who Is on the Research Team?

JR

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
See 2 more

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.
See 2 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: JNJ-88260237Experimental Treatment1 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: PlaceboPlacebo Group1 Intervention
Participants in Cohorts 1 to 4 and 6 will receive single oral dose of matching placebo on Day 1.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

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 profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

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

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security