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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05114889




Registration number
NCT05114889
Ethics application status
Date submitted
9/09/2021
Date registered
10/11/2021
Date last updated
1/08/2023

Titles & IDs
Public title
Safety and Tolerability of BSI-045B in Healthy Adult Subjects and Patients With Atopic Dermatitis
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate Safety and Tolerability of BSI-045B mAb Injection in Healthy Adult Subjects and Patients With Atopic Dermatitis
Secondary ID [1] 0 0
BSI-045B-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BSI-045B

Experimental: Single Ascending Dose Healthy Volunteer - BSI-045B

Experimental: Multiple Ascending Dose Healthy Volunteer - BSI-045B

Experimental: Single Dose Atopic Dermatitis patients - BSI-045B


Other interventions: BSI-045B
BSI-045B will be administered weekly, subcutaneously
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
baseline to 17 weeks
Primary outcome [2] 0 0
Laboratory Tests
Timepoint [2] 0 0
baseline to 17 weeks
Primary outcome [3] 0 0
Vital signs
Timepoint [3] 0 0
baseline to 17 weeks
Primary outcome [4] 0 0
ECG
Timepoint [4] 0 0
baseline to 17 weeks
Secondary outcome [1] 0 0
Pharmacokinetic parameters
Timepoint [1] 0 0
baseline to 17 weeks
Secondary outcome [2] 0 0
Pharmacodynamics (PD)
Timepoint [2] 0 0
baseline to 17 weeks
Secondary outcome [3] 0 0
Immunogenicity
Timepoint [3] 0 0
baseline to 17 weeks
Secondary outcome [4] 0 0
Clinical activity
Timepoint [4] 0 0
baseline to 16 weeks

Eligibility
Key inclusion criteria
- Subject eligibility is determined according to the following criteria prior to entry
into the study:

1. In the opinion of the Investigator, the subject is capable of understanding and
complying with protocol requirements.

2. The subject signs and dates a written Informed Consent Form (ICF) and any
required privacy authorization prior to the initiation of any study procedures.

3. The subject is a healthy adult male or female.

4. The subject is aged 18 to 55 years, inclusive at the time of consent.

5. 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.

6. 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.

7. 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.

8. The subject has a negative urine/blood result for drugs of abuse (defined as any
illicit drug use) at Screening or on Day -1.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any subject who meets any of the following criteria will not qualify for entry into
the study:

1. 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.

2. 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.

3. 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.

4. The subject has a known hypersensitivity to any component of the formulation of
BSI-045B.

5. 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.

6. The subject has taken any prohibited concomitant medications (Section 5.5).

7. The subject had a major elective surgical procedure within 8 weeks prior to Day
1.

8. 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.

9. 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

10. The subject has had previous episodes of seizures or convulsions (lifetime)
including absence seizure and febrile convulsion.

11. The subject or any immediate family member has a history of epilepsy (including
febrile convulsions).

12. 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.

13. The subject has a history of cerebral arteriosclerosis.

14. 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).

15. The subject has a positive test result for hepatitis B surface antigen (HbsAg),
anti- hepatitis C virus (HCV), or a known history of human immunodeficiency virus
(HIV) infection at Screening.

16. The subject has poor peripheral venous access.

17. The subject has donated or lost =450 mL of his or her blood (including
plasmapheresis) or had a transfusion of any blood product within 90 days prior to
Day 1.

18. The subject has an abnormal (clinically significant) electrocardiogram (ECG) at
Screening or on Day -1. Entry of any subject with an abnormal (not clinically
significant) ECG must be approved and documented by signature of the Principal
Investigator or medically qualified Sub-Investigator. In the case of a corrected
QT interval (Fridericia) (QTcF) >450 ms or >470 ms (HVs or AD patients with
bundle branch block) or PR interval outside the range of 115 to 220 ms,
assessment may be repeated once for eligibility determination at Screening and/or
on Day -1.

19. The subject has a supine systolic blood pressure <90 or >144 mm Hg or a supine
diastolic blood pressure <50 or >94 mm Hg. If out of range, assessment may be
repeated once for eligibility determination at Screening and/or on Day -1.

20. The subject has a resting heart rate <40 or >90 bpm (not on ECGs) and considered
clinically significant by the Investigator. If out of range, the assessment may
be repeated once for eligibility determination at Screening and/or on Day -1.

21. The subject has abnormal laboratory values at Screening that suggest a clinically
significant underlying disease, or the subject has the following laboratory
abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase
(AST) >1.5 times the upper limit of normal unless otherwise agreed to by the
Sponsor and Principal Investigator.

In addition to the general criteria above, AD patients in Part B must meet the following
inclusion criteria to enter the study:

1. The patient has a diagnosis of AD (according to the criteria established by Hanifin et
al, 2001 and Rajka et al, 1989).

2. The EASI score is =15 at Screening.

3. The score on the Investigator's Global Assessment is =3 at Screening.

4. The score on the SCORing Atopic Dermatitis instrument is =20 at Screening.

5. The total body surface area affected by AD is =10% as assessed by the EASI at
Screening.

6. The patient has an inadequate response to topical medications, or topical treatment is
medically inadvisable.

In addition to the general criteria above, AD patients in Part B must not meet any of the
following exclusion criteria:

1. The patient has another dermatologic condition that might confound a diagnosis of AD
or a treatment assessment.

2. The patient has a history of anaphylaxis following biologic therapy.

3. The patient has a history of clinically significant infections within 4 weeks prior to
Day -1.

4. The patient has a diagnosis of helminthic parasitic infection within 6 months prior to
Screening.

5. The patient has received any marketed or investigational biologic agent within 5
half-lives prior to Screening.

6. The patient has received treatment with immunosuppressive or immunomodulatory drugs
without adequate washout, or has received phototherapy for AD within 4 weeks prior to
Day 1. For drugs, an adequate washout period is 5 half-lives (e.g., 10 weeks for
dupilumab).

7. The patient has initiated treatment with topical corticosteroids (TCS) or topical
calcineurin inhibitors within 1 week prior to Day -1. If rescue medications are deemed
warranted by the PI class IV TCS may be used as rescue medication after Day -1 (see
Table 13).

8. The patient has initiated treatment with prescription moisturizers or moisturizers
containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation
products during the Screening period (patients may continue to use stable doses of
such moisturizers if initiated before the Screening visit, but should not change to a
different product during the study).

9. The patient plans to use any other prohibited medication or undergo any prohibited
procedure during the study. Oral antibiotics are permitted. Bleach baths are not
permitted.

10. The patient has received any investigational compound within 30 days or 5 half-lives
(whichever is greater) days prior to Day 1.

11. The subject has a risk of suicide per the Columbia-Suicide Severity Rating Scale (a
score of 4 or above on ideation or any suicidal behavior) or according to the
Investigator's clinical judgment, has made a suicide attempt in the previous 6 months,
or has a history of deliberate self-harm in the past 6 months. A subject with a lower
score may be enrolled in the study.

12. The patient has any clinically relevant abnormal finding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/02/2023
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 0 0
- Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biosion, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Southern Star Research Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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. 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05114889
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Argent, M.D.
Address 0 0
Scientia Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05114889