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

NCT05114889 | Completed Phase 1 DMC

• 1 other identifier: BSI-045B-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

• Treatment-emergent adverse events (TEAEs)

  The incidence of TEAEs (AEs and SAEs) summarized by system organ class and preferred term.

  baseline to 17 weeks

• Laboratory Tests

  Number of subjects with clinically significant change from baseline in safety lab (e.g. hematology, chemistry)

  baseline to 17 weeks

• Vital signs

  Number of subjects with clinically significant change from baseline in vital signs (heart rate, blood pressure, and weight)

  baseline to 17 weeks

• ECG

  Number of subjects with clinically significant change from baseline in ECG (rhythm, QT interval)

  baseline to 17 weeks

Secondary Outcomes (4)

• Pharmacokinetic parameters

  baseline to 17 weeks

• Pharmacodynamics (PD)

  baseline to 17 weeks

• Immunogenicity

  baseline to 17 weeks

• Clinical activity

  baseline to 16 weeks

Study Arms (3)

Single Ascending Dose Healthy Volunteer

EXPERIMENTAL

BSI-045B

Biological: BSI-045B

Multiple Ascending Dose Healthy Volunteer

EXPERIMENTAL

BSI-045B

Biological: BSI-045B

Single Dose Atopic Dermatitis patients

EXPERIMENTAL

BSI-045B

Biological: BSI-045B

Interventions

BSI-045B BIOLOGICAL

BSI-045B will be administered weekly, subcutaneously

Multiple Ascending Dose Healthy Volunteer; Single Ascending Dose Healthy Volunteer; Single Dose Atopic Dermatitis patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject eligibility is determined according to the following criteria prior to entry into the study:
• In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements.
• The subject signs and dates a written Informed Consent Form (ICF) and any required privacy authorization prior to the initiation of any study procedures.
• The subject is a healthy adult male or female.
• The subject is aged 18 to 55 years, inclusive at the time of consent.
• A female subject weighs at least 45 kg and a male subject weighs at least 50 kg. The subject has a body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive at Screening.
• A male subject who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use highly effective contraception from the time of signing the ICF throughout the duration of the study and for 90 days (\~5 half-lives) have elapsed since the last dose of study drug. Examples of highly effective contraception can be found in Appendix 1.
• A female subject of childbearing potential who is sexually active with a non-sterilized male partner agrees to routinely use highly effective contraception from the time of signing the ICF throughout the duration of the study and for 90 days have elapsed since the last dose of study drug. Examples of highly effective contraception can be found in Appendix 1.
• The subject has a negative urine/blood result for drugs of abuse (defined as any illicit drug use) at Screening or on Day -1.

You may not qualify if:

• Any subject who meets any of the following criteria will not qualify for entry into the study:
• The subject has received any investigational compound within 30 days or five half-lives (whichever is greater) prior to the first dose of study drug.
• The subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of the study (e.g., spouse, parent, child, sibling) or makes consent under duress.
• The subject has any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, neurologic, immunologic, endocrine, or psychiatric disease or disorder, current infection with coronavirus disease 2019 (COVID-19), or other abnormality that may affect safety, increase the risk for seizure or lower the seizure threshold, or potentially confound the study results. It is the responsibility of the Investigator to assess the clinical significance of a subject's condition; however, consultation with the Biosion Medical Monitor may be warranted.
• The subject has a known hypersensitivity to any component of the formulation of BSI-045B.
• The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to Screening or is unwilling to agree to abstain from alcohol and drugs throughout the study.
• The subject has taken any prohibited concomitant medications (Section 5.5).
• The subject had a major elective surgical procedure within 8 weeks prior to Day 1.
• The subject is pregnant or lactating or intends to become pregnant or donate ova before, during, or within 90 days (\~ 5 half-lives) since the last dose of study drug.
• If male, the subject intends to donate sperm during the course of this study or within 90 days (\~ 5 half-lives) since the last dose of study drug
• The subject has had previous episodes of seizures or convulsions (lifetime) including absence seizure and febrile convulsion.
• The subject or any immediate family member has a history of epilepsy (including febrile convulsions).
• The subject has a history of neurologic abnormalities including abnormal electroencephalography, brain injury including traumatic injury, perinatal cerebropathy, postnatal brain damage, blood-brain barrier abnormality, and cavernous angioma.
• The subject has a history of cerebral arteriosclerosis.
• The subject has a history of cancer. Subjects with basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix may be included in the study if they have completed curative treatment at least 12 months before the first visit. Subjects with other malignant tumors may be included if they have completed curative treatment at least 5 years before the first visit (Day 1).

Sponsors & Collaborators

• Southern Star Research: collaborator
• Biosion, Inc.: lead

Study Sites (1)

Scientia Clinical Research

Randwick, New South Wales, Australia

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Argent Christopher

  Scientia Clinical Research Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: November 10, 2021
• Study Start: October 25, 2021
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)