A Phase 1 study of BFKB8488A in Japanese NAFLD patients.

JRCT ID: jRCT2051210005

Registered date:09/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: nonalcoholic fatty liver disease
• Date of first enrollment: 12/06/2021
• Target sample size: 32
• Study type: Interventional
• Intervention(s): BFKB8488A : 50-130mg Q2W

Outcome(s)

Primary Outcome

safety
Confirm the safety and tolerability of repeated subcutaneous administration of BFKB8488A by comparison with placebo
- Adverse events
- Vital signs
- Laboratory examination
- 12-lead electrocardiogram
phamacokinetics
Evaluate the pharmacokinetic profile of repeated subcutaneous doses of BFKB8488A
- BFKB8488A serum levels and other pharmacokinetic parameters

Secondary Outcome

other
Evaluate immunogenicity after repeated subcutaneous administration of BFKB8488A
- Expression frequency of Anti-Drug Antibodies against BFKB8488A

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

- Subjects who signed informed consent form
- Japanese subjects at 20-75 years old
- Diagnosed with NAFLD
- Body Mass Index (BMI) of 25-40
- Confirmed a certain amount of liver fat by ultrasonography and MRI

Exclude criteria

- With a history or current liver diseases, liver dysfunction, or liver disease-related symptoms other than NAFLD
- With a history of liver transplantation
- With a history or current of eating disorders
- Current with Type 1 diabetes, or uncontrolled type 2 diabetes
- With a history or current of significant cardiac disease
- With a history or current of severe allergic reaction
- Current receiving weight loss therapy or diet therapy
- With a history of alcohol abuse
- A certain amount of blood loss due to blood donation
- Women who are pregnant, breastfeeding, possibly pregnant

Related Information

• Primary Sponsor: Nanki Toshihiro