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JNJ-88260237 for Healthy Subjects

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
Awards & highlights

Study Summary

This trial will test the safety of a new drug, JNJ-88260237, in healthy volunteers. Researchers will monitor participants for any adverse effects.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,268 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,865 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications are necessary to participate in this clinical investigation?

"In order to be accepted into the trial, applicants must have healthy subjects status and fall between 25-55 years of age. This study is currently recruiting roughly 48 individuals for participation."

Answered by AI

Are there vacancies available for participants in this investigation?

"As per the clinicaltrials.gov website, enrollment for this medical trial is underway. It first appeared on September 14th 2022 and was last amended on November 8th of the same year."

Answered by AI

What benefits are expected to be derived from this medical experiment?

"Per the trial sponsor, Janssen Research & Development LLC, their primary assessment period is 14 days and will measure Participant Abnormalities in Vital Signs. Secondary measurements will evaluate Apparent Volume of Distribution (Vz/F), Apparent Oral Whole Blood Clearance (CL/F) ,and Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Infinite Time (AUC [0-Infinity]) for JNJ-88260237."

Answered by AI

Has the FDA authorized JNJ-88260237 for public consumption?

"Due to being in the earliest stages of clinical research, our team at Power has assigned JNJ-88260237 a safety rating of 1. As such, there is limited data currently available regarding its efficacy and safety."

Answered by AI

How many individuals are being enrolled in the trial at this juncture?

"Affirmative. Clinicaltrials.gov reports that the experiment, which was first posted on September 14th 2022, is still in search of applicants. The study aims to recruit 48 individuals from a single medical centre."

Answered by AI

Are seniors admissible for this clinical experiment?

"Applicants aged 25 to 55 are qualified for this medical trial. There are 50 clinical trials available specifically for minors, and 373 experiments catered towards elderly individuals."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Single Ascending Dose Study of JNJ-88260237 in Healthy Participants
2022. "A Single Ascending Dose Study of JNJ-88260237 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05541315.
~15 spots leftby Apr 2025
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