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

NCT05114889 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-09-19

No results posted yet for this study

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

Conditions

Interventions

BIOLOGICAL

BSI-045B

BSI-045B will be administered weekly, subcutaneously

Sponsors & Collaborators

  • Southern Star Research

    collaborator INDUSTRY

  • Biosion, Inc.

    lead INDUSTRY

Principal Investigators

  • Argent Christopher · Scientia Clinical Research Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2023-02-15
Completion
2023-02-15

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05114889 on ClinicalTrials.gov