Not Yet RecruitingPhase 1ACTRN12625001434482

A Single and Multiple Ascending Dose Study of JNJ-90858638 in Healthy Participants (Part 1 and 2: Single and Multiple Ascending Dose)

A Phase 1, Single and Multiple Ascending Dose, Drug-drug Interaction, and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-90858638 in Healthy Participants (Part 1 and 2: Single and Multiple Ascending Dose)

Sponsor

Janssen Research & Development, LLC

Enrollment

120 participants

Start Date

Jan 8, 2026

Study Type

Interventional

Conditions

Autoimmune Diseases

Summary

The purpose of this study is to assess the safety and tolerability of JNJ-90858638 compared with placebo after single and multiple ascending dose administration in healthy participants (Part 1 and 2).

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria4

Healthy on the basis of physical examination, medical history, vital signs,12-lead electrocardiogram (ECG) and echocardiography performed at screening and/or Day-1
Body mass index (BMI) between 18 and 32 kilogram/meter square (kg/m^2), and a body weight of no less than 50 kg
All females must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test on Day -1 and agree to further pregnancy tests
Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria5

History of chronic liver or renal insufficiency significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Have an active, acute or chronic infection
Has or has had a serious infection (for example [e.g.], sepsis, pneumonia or pyelonephritis) or has been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 4 months prior to screening
Has or has had an acute illness, including a common cold, within 2 weeks prior to study intervention administration
Has or has had a nontuberculous mycobacterial infection or opportunistic infection (for example, cytomegalovirus, pneumocystosis, and aspergillosis) at any time prior to screening

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Interventions

ARM: Experimental: Part 1: Single Ascending Dose (SAD) Cohort Participants will receive a single dose of JNJ-90858638 orally in a fasted or fed state. The high-fat, high-calorie meal will consis

ARM: Experimental: Part 1: Single Ascending Dose (SAD) Cohort Participants will receive a single dose of JNJ-90858638 orally in a fasted or fed state. The high-fat, high-calorie meal will consist of 800-1000 total kilocalorie (kcal) with approximately 500-600 kcal (greater than [>] 50 percent [%]) derived from fat. SAD has 5 planned fasted cohorts, 1 fasted and food effect cohort and 2 optional cohorts; an optional additional food effect cohort, if required. Each participant will participate in 1 cohort only. ASSIGNED INTERVENTION: Drug: JNJ-90858638 JNJ-90858638 will be administered orally. The starting dose for SAD will be 5 milligram (mg); incremental doses are unknown but will be based on PK and safety from preceding cohorts. There is a projected maximum dose of 100 mg. It will be administered by medical professionals including registered nurses. ARM: Experimental: Part 2: Multiple Ascending Dose (MAD) Cohort Participants will receive oral doses of JNJ-90858638 once daily for 28 days in MAD in an ascending fashion in a fasted or fed based (standard meal) state; the dosing regimen will be confirmed based on SAD pharmacokinetic (PK) and safety data. The standard meal will consist of 500-800 kcal with approximately 25-50% of kcal derived from fat. A total of 6 cohorts are planned for Part 2 (4 escalating cohorts [Cohorts 1 to 4] and 2 optional cohorts [Cohorts 5 and 6]). Each participant will participate in 1 cohort only ASSIGNED INTERVENTION: Drug: JNJ-90858638 JNJ-90858638 will be administered orally. The starting dose for MAD will be selected based on PK and safety data from the preceding SAD part. It will be administered by medical professionals including registered nurses.