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

Phase 1

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cohort 1 to 4 and cohort 6: up to day 7; cohort 5: up to day 21

Summary

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cohort 1 to 4 and cohort 6: up to day 7; cohort 5: up to day 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cohort 1 to 4 and cohort 6: up to day 7; cohort 5: up to day 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and cohort 1 to 4 and cohort 6: up to day 7; cohort 5: up to day 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters

Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Electrocardiogram (ECG)

Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Physical Examinations

+7 more

Secondary study objectives

Apparent Oral Whole Blood Clearance (CL/F) of JNJ-88260237

Apparent Volume of Distribution (Vz/F) of JNJ-88260237

Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Infinite Time (AUC [0-Infinity]) of JNJ-88260237

+4 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JNJ-88260237

2022

Completed Phase 1

~40

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