NCT05655221

A Trial to Evaluate the Safety Tolerability and Pharmacokinetics of B1344 by Subcutaneous Injection in Healthy Subjects

A First-in-human, Randomized, Double-blind, Parallel, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of B1344 by Subcutaneous Injection in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Tasly Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability, and immunogenicity of B1344 by single subcutaneous (s.c.) injection in healthy subjects

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	B1344	multi-site abdominal s.c. injections (maximum 2 mL at each site)
OTHER	Placebo	multi-site abdominal s.c. injections (maximum 2 mL at each site)

Timeline

• Start date: 2022-08-30
• Primary completion: 2023-07-31
• Completion: 2024-01-30
• First posted: 2022-12-19
• Last updated: 2022-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study