| Trial ID: | L0387 |
| Source ID: | JPRN-jRCT2051210005
|
| Associated Drug: |
BFKB8488A
|
| Title: |
A Double-blind, Radomized, Placebo-Controlled, Phase 1 Study, to Evaluate the Safety, Tolerability, and Pharmacokinetics of BFKB8488A in Japanese Nonalcoholic Fatty Liver Disease (NAFLD) patients.
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
nonalcoholic fatty liver disease
|
| Interventions: |
BFKB8488A : 50-130mg Q2W
|
| Outcome Measures: |
safety<br>Confirm the safety and tolerability of repeated subcutaneous administration of BFKB8488A by comparison with placebo<br>- Adverse events<br>- Vital signs<br>- Laboratory examination<br>- 12-lead electrocardiogram<br>phamacokinetics<br>Evaluate the pharmacokinetic profile of repeated subcutaneous doses of BFKB8488A<br>- BFKB8488A serum levels and other pharmacokinetic parametersother<br>Evaluate immunogenicity after repeated subcutaneous administration of BFKB8488A<br>- Expression frequency of Anti-Drug Antibodies against BFKB8488A
|
| Sponsor/Collaborators: |
Nanki Toshihiro
|
| Gender: |
All
|
| Age: |
>= 20age old<= 75age old
|
| Phases: |
Phase 1
|
| Enrollment: |
32
|
| Study Type: |
Interventional
|
| Study Designs: |
randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose
|
| Start Date: |
09/04/2021
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
10 January 2022
|
| Locations: |
Japan
|
| URL: |
https://jrct.niph.go.jp/latest-detail/jRCT2051210005
|
