A Safety and Tolerability Study of JNJ-72537634 in Healthy Participants

NCT03931447 | Completed Phase 1

• 3 other identifiers: CR10861572537634IBD10012018-003700-39
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the safety and tolerability of JNJ-72537634 compared with placebo in healthy participants after administration of single and multiple day doses.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Part 1 Single Day (SD) Dose: Percentage of Participants With Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) as a Measure of Safety and Tolerability

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are adverse events (AEs) which will occur up to 24 Weeks that were absent before treatment or that worsened relative to pre-treatment state. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Up to 24 Weeks post final dose

• Part 2 Multiple Day (MD) Dose: Percentage of Participants With TEAE and SAE as a Measure of Safety and Tolerability

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs which will occur up to 26 Weeks that were absent before treatment or that worsened relative to pre-treatment state. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Up to 26 Weeks post final dose

• Part 1 SD: Number of Participants With Abnormalities in Vital Signs, Electrocardiogram (ECG) and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability

  Number of participants with abnormalities in vital signs, ECG and clinically significant laboratory findings will be reported.

  Up to 12 Weeks post final dose

• Part 2 MD: Number of Participants With Abnormalities in Vital Signs, ECG and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability

  Number of participants with abnormalities in vital signs, ECG and clinically significant laboratory findings will be reported.

  Up to 14 Weeks post final dose

Secondary Outcomes (2)

• Part 1: Detection and Abundance of JNJ-72537634

  Up to 24 Weeks

• Part 2: Detection and Abundance of JNJ-72537634

  Up to 26 Weeks

Study Arms (4)

Cohort 1: JNJ-72537634 Dose 1 or Placebo (Part 1 - SD)

EXPERIMENTAL

Each participant will receive pretreatment with oral antibiotic; followed by a single day (SD) study intervention of JNJ-72537634 at dose 1 or placebo after overnight fast on Day 1.

Biological: JNJ-72537634; Biological: Placebo

Cohort 2: JNJ-72537634 Dose 2 or Placebo (Part 1 - SD)

EXPERIMENTAL

Each participant will receive pretreatment with oral antibiotic; followed by a SD study intervention of JNJ-72537634 at dose 2 or placebo after overnight fast on Day 1.

Biological: JNJ-72537634; Biological: Placebo

Cohort 3: JNJ-72537634 Dose 1 or Placebo (Part 2 - MD)

EXPERIMENTAL

Each participant will receive pretreatment with oral antibiotic; followed by a multiple day (MD) study intervention of JNJ-72537634 at dose 1 or placebo after overnight fast on Day 1 for 14 consecutive days.

Biological: JNJ-72537634; Biological: Placebo

Cohort 4: JNJ-72537634 Dose 2 or Placebo (Part 2 - MD)

EXPERIMENTAL

Each participant will receive pretreatment with oral antibiotic; followed by a MD study intervention of JNJ-72537634 at dose 2 or placebo after overnight fast on Day 1 for 14 consecutive days.

Biological: JNJ-72537634; Biological: Placebo

Interventions

JNJ-72537634 BIOLOGICAL

Participants in Cohort 1 and 3 will receive Dose 1 and participants in Cohort 2 and 4 will receive Dose 2 of JNJ-72537634 as oral capsule.

Cohort 1: JNJ-72537634 Dose 1 or Placebo (Part 1 - SD); Cohort 2: JNJ-72537634 Dose 2 or Placebo (Part 1 - SD); Cohort 3: JNJ-72537634 Dose 1 or Placebo (Part 2 - MD); Cohort 4: JNJ-72537634 Dose 2 or Placebo (Part 2 - MD)

Placebo BIOLOGICAL

Participants will receive matching placebo as oral capsule in all cohorts.

Cohort 1: JNJ-72537634 Dose 1 or Placebo (Part 1 - SD); Cohort 2: JNJ-72537634 Dose 2 or Placebo (Part 1 - SD); Cohort 3: JNJ-72537634 Dose 1 or Placebo (Part 2 - MD); Cohort 4: JNJ-72537634 Dose 2 or Placebo (Part 2 - MD)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of at least 50 kilogram (kg)
• Be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening
• Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant
• Have normal bowel movements, ranging from 1 to 3 times daily to every other day and have normal consistencies according to the Bristol Stool Scale, ranging from 3 to 5 at admission
• All women of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test on day of admission

You may not qualify if:

• History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
• Has an active systemic or GI acute or chronic infection as determined by appropriate clinical screening and laboratory tests
• If female, has a positive serum pregnancy test at screening, a positive urine pregnancy test at admission, or is lactating prior to study enrollment
• An active cigarette smoker or has quit cigarette smoking within the previous 6 months
• Has a positive urine toxicology screen at screening or at admission for substances of abuse including but not limited to: barbiturates, benzodiazepines, tetrahydrocannabinol (THC), cocaine, opiates, methamphetamines, tricyclic antidepressants (TCA), methadone, 3,4-methylenedioxymethamphetamine (MDMA), oxycodone, and amphetamines

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

Related Publications (1)

• Silber JL, Norman JM, Kanno T, Crossette EM, Szabady R, Menon R, Marko M, Hao LY, Tomsho L, Bhagat S, Yuan A, Olle B, Lamouse-Smith E. A randomized, double-blind, placebo-controlled, single- and multiple-dose phase 1 study of VE202, a defined bacterial consortium for treatment of inflammatory bowel disease: safety and colonization dynamics of a novel live biotherapeutic product in healthy adults. Eur J Gastroenterol Hepatol. 2025 Oct 23. doi: 10.1097/MEG.0000000000003098. Online ahead of print.

  PMID: 41342324 DERIVED

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: April 26, 2019
• First Posted: April 30, 2019
• Study Start: April 30, 2019
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)