Safety and Tolerability of BSI-045B in Healthy Adult Subjects and Patients With Atopic Dermatitis

Summary

This randomized, double-blind, single center, placebo-controlled, phase 1 single ascending dose (SAD)/multiple ascending dose (MAD) study is designed to assess the safety, tolerability, PK, activity, immunogenicity, and PD of BSI-045B. Approximately 68 subjects will be enrolled. Subjects in this study include 56 healthy volunteers (HVs) and 12 patients with AD. This study is divided into 3 parts: 1. Part A: Evaluate the safety, tolerability, PK, immunogenicity, and PD of single ascending doses of BSI-045B administered as a subcutaneous (SC) injection of 120, 240, 480, and 720 mg to HVs 2. Part B: Evaluate the safety, tolerability, PK, activity (as measured by the Eczema Area and Severity Index \[EASI\] score), immunogenicity, and PD of a single dose of BSI-045B administered as a SC injection of 480 mg to patients with AD 3. Part C: Evaluate the safety, tolerability, PK, immunogenicity, and PD of multiple ascending doses of BSI-045B administered as five (5) SC injections of 240, 480, and 600 mg every 7 days (Q7D) to HVs

Timeline

Start

2021-10-25

Primary completion

2023-02-15

Completion

2023-02-15

Drugs

Indications