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

NCT05541315 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10922788260237CKD1001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (10)

• Cohort 1 to 4 and Cohort 6: Number of Participants with Adverse Events (AEs)

  Number of participants with AEs will be reported.

  Up to Day 14

• Cohort 5: Number of Participants with Adverse Events (AEs)

  Number of participants with AEs will be reported.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Up to Day 21

Secondary Outcomes (7)

• Maximum Observed Whole Blood Concentration (Cmax) of JNJ-88260237

  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

  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

  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

  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

  Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

JNJ-88260237 DRUG

JNJ-88260237 will be administered orally.

JNJ-88260237

Placebo DRUG

Matching placebo will be administered orally.

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 15, 2022
• Study Start: September 14, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)