Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001199606
Ethics application status
Approved
Date submitted
26/10/2023
Date registered
21/11/2023
Date last updated
11/07/2024
Date data sharing statement initially provided
21/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after single and multiple ascending dose administrations in healthy participants
Scientific title
A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after single and multiple ascending dose administrations in healthy participants
Secondary ID [1] 310808 0
FB102-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autoimmune and Inflammatory Diseases


 331800 0
Condition category
Condition code
Inflammatory and Immune System 328535 328535 0 0
Autoimmune diseases
Inflammatory and Immune System 328536 328536 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized, double-blind, placebo-controlled study of FB102 in healthy participants. Part A is the single ascending dose (SAD) portion, and Part B is the multiple ascending dose (MAD) portion.

Part A: (SAD) Up to 6 groups (Groups A1 to A6) of 8 healthy participants per group.
Group A1: 3 mg/kg Intravenous (IV) dose
Group A2: 7.5 mg/kg IV dose
Group A3: 15 mg/kg IV dose
Group A4: 1 mg/kg Subcutaneous (SC) dose
Group A5: 3 mg/kg SC dose
Group A6: IV or SC dose (TBD) of FB102*
* The SMC will determine the dose for Group A6 based on cumulative review of safety and PK data from prior groups. The dose will not exceed 15 mg/kg.

Part B: (MAD) Up to 4 groups (Groups B1 to B4) of 8 healthy participants. Within each group, participants will receive 4 weekly doses
Group B1: 3 mg/kg IV doses
Group B2: 10 mg/kg IV doses
Group B3: 15 mg/kg IV doses
Group B4: multiple lV or SC doses (TBD)#
#The SMC will determine the dose and route (IV or SC) for Group B4 based on cumulative
review of safety and PK data from prior groups. The dose will not exceed 15 mg/kg.

Adherence to Intervention will be managed via recording in appropriate drug accountability records.
Intervention code [1] 327220 0
Treatment: Drugs
Comparator / control treatment
Placebo will be formulated the same as the Investigational Product (IP) in 25mM L-Histidine, 9% sucrose,0.1% polysorbate 80 without the antibody.
Control group
Placebo

Outcomes
Primary outcome [1] 336355 0
To assess the safety and tolerability of single intravenous (IV) and subcutaneous (SC) doses of FB102.
Timepoint [1] 336355 0
Adverse events - will be graded using the most current version of the Common Terminology Criteria for Adverse Events (CTCAE) (Version 5) and assessed continuously as they are reported or observed and reviewed daily through to end of study.

Electrocardiogram (ECG) - single 12-lead ECG recordings will be obtained at screening, pre-dose Day 1 - 1 and 6 hrs post-dose. Days 2, 3, 8, 15, 22, 36, 50 and Day 85 post commencement of intervention.

Vital signs - Blood pressure and heart rate is measured using sphygmomanometer, respiratory rate by manual breath count and temperature by thermometer. Measured from screening, Day -1, pre-dose Day 1 - 1, 2, 6 & 12 hrs post-dose, then daily on Day 2, 3, 8, 15, 22, 36, 50 and Day 85 post commencement of intervention.

Clinical laboratory evaluations (haematology, serum chemistry and urinalysis) - blood and urine samples will be collected from screening, Day -1, Days 2, 8, 15, 22, 36, 50 and Day 85 post commencement of intervention.

Physical examinations will be conducted at screening and then symptom-directed examinations conducted as required daily on Days -1, 1, 2, 8, 15, 22, 36, 50 and Day 85 post commencement of intervention.


Primary outcome [2] 336356 0
To assess the safety and tolerability of multiple intravenous (IV) and subcutaneous (SC) doses of FB102.
Timepoint [2] 336356 0
Adverse events - will be graded using the most current version of the Common Terminology Criteria for Adverse Events (CTCAE) (Version 5) and assessed continuously as they are reported or observed and reviewed daily through to end of study.

Electrocardiogram (ECG) - single 12-lead ECG recordings will be obtained at screening, Day -1, pre-dose Day 1 - 1 and 6 hrs post-dose. Days 2, 3, 8, 15, pre-second dose Day 22 - 1 and 6 hrs post-second dose, Days 23, 24, 29, 36, 50, 78 and Day 113 post commencement of intervention.

Vital signs - Blood pressure and heart rate is measured using sphygmomanometer, respiratory rate by manual breath count and temperature by thermometer. Measured from screening, Day -1, pre-dose Days 1, 8, 15, and 22, then 1, 2, 6, 12, 24 and 48 hrs post-dose, daily on Days 3, 23, 24, 29, 36, 50, 78 and Day 113 post commencement of intervention.

Clinical laboratory evaluations (haematology, serum chemistry and urinalysis) - blood and urine samples will be collected from screening, Day -1, Day 2, pre-dose Days 8, 15, and 22, then Days 36, 50, 78 and Day 113 post commencement of intervention.

Physical examinations will be conducted at screening and then symptom-directed examinations conducted as required daily on Days -1, 1, 2, 8, 15, 22, 36, 50, 78 and Day 113 post commencement of intervention.
Secondary outcome [1] 427991 0
To characterize the pharmacokinetics (PK) of single IV and SC doses of FB102.
Timepoint [1] 427991 0
Blood serum samples will be collected for single IV dose on Day 1 pre-dose and 0.083, 0.25, 1, 3, 6, and 12 hrs post-dose, Days 2, 3, 8, 15, 22, 36, 50 and Day 85 post commencement of intervention.

Blood serum samples will be collected for single-dose SC on Day 1 pre-dose and 1, 6, 12, 24, 36, 48, 60, 72, and 84 hours post-dose. Days 8, 15, 22, 36, 50 and Day 85 post commencement of intervention.
Secondary outcome [2] 427992 0
To characterize the PK of multiple IV doses of FB102.
Timepoint [2] 427992 0
Blood serum samples will be collected Day 1 pre-dose and 0.083, 0.25, 1, 3, 6, 12, 24, and 48 hours post-dose, pre-dose Day 8 and 15, Day 22 pre-dose and 0.083, 0.25, 1, 3, 6, 12, 24, and 48 hours post-dose. Days 29, 36, 50, 78 and Day 113 post commencement of intervention.
Secondary outcome [3] 427993 0
To evaluate the immunogenicity of FB102 following single IV and SC doses of FB102.
Timepoint [3] 427993 0
Blood serum samples will be collected pre-dose Day 1 then on Days 8, 36, 50 and Day 85 post commencement of intervention.
Secondary outcome [4] 427994 0
To evaluate the immunogenicity of FB102 following multiple IV doses of FB102.
Timepoint [4] 427994 0
Blood serum samples will be collected pre-dose Day 1 then at any time during visits on Day 15, 29, 50, 78 and Day 113 post commencement of intervention.

Eligibility
Key inclusion criteria
1. Men and women ages 18 to 60 years old, inclusive, at screening.
2. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at screening.
3. Weight greater than or equal to 50 kg and less than or equal to 100kg for men and greater than or equal to 45 kg and less than or equal to 95kg for women.
4. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
5. Willing and able to understand and sign the participant informed consent form (PICF).
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of any clinically significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies, significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), immunosuppressive conditions or medications, recent or recurrent infections, or any other clinically significant disease, as assessed by the Investigator. Basal cell or squamous cell carcinoma of the skin that has been fully excised and is considered cured is acceptable.
2. Any other medical condition or social circumstance, which in the opinion of the Investigator, would impede compliance with or hinder completion of the study.

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)
Participants will be randomized 3:1 to receive FB102 or placebo. The unblinded CRO biostatistician will prepare the study randomization schedule and treatment assignment list and distribute to the site’s unblinded pharmacy team to be kept in an area with restricted access per institutional guidelines. Emergency unblinding codes will be stored securely by the unblinded pharmacy at the research facility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization schedule and corresponding treatment assignment will be generated by the CRO’s biostatistics department per CRO standard operating procedures (SOPs).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Participant disposition and demographic characteristics will be summarized using descriptive statistic for the safety Population. All participants administered any amount of study drug will be included in the safety analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/12/2023
Actual
6/12/2023
Date of last participant enrolment
Anticipated
1/08/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25765 0
Linear Clinical Research - Joondalup - Joondalup
Recruitment postcode(s) [1] 41590 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 315050 0
Commercial sector/Industry
Name [1] 315050 0
Forte Biosciences Australia Pty Ltd
Country [1] 315050 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Forte Biosciences Australia Pty Ltd
Address
Suite 7 Level 7 330 Collins Street Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 317073 0
Commercial sector/Industry
Name [1] 317073 0
Avance Clinical Pty Ltd
Address [1] 317073 0
213 Glynburn Road, Firle, South Australia, 5070
Country [1] 317073 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314005 0
Bellberry Limited HREC
Ethics committee address [1] 314005 0
Ethics committee country [1] 314005 0
Australia
Date submitted for ethics approval [1] 314005 0
18/10/2023
Approval date [1] 314005 0
15/11/2023
Ethics approval number [1] 314005 0
2023-04-456

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130094 0
Prof Michaela Lucas
Address 130094 0
Linear Clinical Research - Joondalup, 14/189 Lakeside Dr, Joondalup WA 6027
Country 130094 0
Australia
Phone 130094 0
+61 0466553256
Fax 130094 0
Email 130094 0
[email protected]
Contact person for public queries
Name 130095 0
Michaela Lucas
Address 130095 0
Linear Clinical Research - Joondalup, 14/189 Lakeside Dr, Joondalup WA 6027
Country 130095 0
Australia
Phone 130095 0
+61 0466553256
Fax 130095 0
Email 130095 0
[email protected]
Contact person for scientific queries
Name 130096 0
Michaela Lucas
Address 130096 0
Linear Clinical Research - Joondalup, 14/189 Lakeside Dr, Joondalup WA 6027
Country 130096 0
Australia
Phone 130096 0
+61 0466553256
Fax 130096 0
Email 130096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.