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| ID | Type | Description | Link |
|---|---|---|---|
| 75220795NAS1002 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to assess the safety and tolerability of single subcutaneous (SC) dose of JNJ-75220795 in Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: JNJ-75220795 or Placebo | Experimental | Participants will receive single subcutaneous (SC) dose of JNJ-75220795 Dose 1 or matching placebo on Day 1 in Cohort 1. |
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| Cohort 2: JNJ-75220795 or Placebo | Experimental | Participants will receive single SC dose of JNJ-75220795 Dose 2 or matching placebo on Day 1 in Cohort 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-75220795 | Drug | JNJ-75220795 will be administered as SC injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Signs and Symptoms/Adverse Events (AEs) | Number of participants with treatment-emergent signs and symptoms/adverse events (including allergic reactions/hypersensitivity and local injection site reactions) will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Treatment-emergent adverse events (TEAEs) are defined as AEs with onset or worsening on or after date of first dose of study treatment. | Up to Day 168 |
| Number of Participants With Change From Baseline in Vital Signs Abnormalities | Number of participants with change from baseline in vital signs abnormalities including body temperature (axillary), pulse, respiratory rate and blood pressure will be reported. | Baseline, Up to Day 168 |
| Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities | Number of participants with change from baseline in clinical laboratory abnormalities including hematology, serum chemistry and urinalysis will be reported. | Baseline, Up to Day 168 |
| Number of Participants With Change From Baseline in Physical Examination Abnormalities | Number of participants with change from baseline in physical examination abnormalities will be reported. | Baseline, Up to Day 168 |
| Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities | Number of participants with change from baseline in ECG abnormalities will be reported. | Baseline, Up to Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Liver Fat Content Measured by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) | Percent change in liver fat content as measured by MRI-PDFF will be reported. | From Baseline to Weeks 6, 12, 18, and 24 |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-75220795 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Souseikai Fukuoka Mirai Hospital | Fukuoka | 813-0017 | Japan | |||
| Medical Corporation Heishinkai ToCROM Clinic |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Other | Matching placebo will be administered as SC injection. |
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Cmax of JNJ-75220795 will be reported. |
| Predose up to 48 hours postdose (up to Day 3) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75220795 | Tmax of JNJ-75220795 will be reported. | Predose up to 48 hours postdose (up to Day 3) |
| Apparent Elimination Half-Life (t1/2) of JNJ-75220795 | t1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve. | Predose up to 48 hours postdose (up to Day 3) |
| Area Under the Plasma Concentration Time Curve of JNJ-75220795 from Time Zero to Infinite time (AUC [0-Infinity]) | AUC (0-Infinity) is defined as the area under the plasma concentration versus time curve of JNJ-75220795 from time zero to infinite time. | Predose up to 48 hours postdose (up to Day 3) |
| Area Under the Plasma Concentration versus Time Curve of JNJ-75220795 from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last]) | AUC (0-Last) is defined as area under the plasma concentration versus time curve of JNJ-75220795 from time zero to time of the last measurable concentration. | Predose up to 48 hours postdose (up to Day 3) |
| Total Apparent Clearance (CL/F) of JNJ-75220795 | CL/F is defined as total apparent clearance of JNJ-75220795. | Predose up to 48 hours postdose (up to Day 3) |
| Apparent Volume of Distribution (Vd/F) of JNJ-75220795 | Vd/F is defined as apparent volume of distribution of JNJ-75220795. | Predose up to 48 hours postdose (up to Day 3) |
| Number of Participants with Treatment Emergent Anti-drug Antibody (ADA) | Number of participants with treatment emergent ADA will be reported. | Up to Day 168 |
| Shinjuku-ku |
| 160-0008 |
| Japan |
| Heishinkai TOCROM Clinic | Suita | 565-0853 | Japan |
| Sumida Hospital | Tokyo | 130-0004 | Japan |