Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000212459p
Ethics application status
Not yet submitted
Date submitted
5/02/2025
Date registered
21/02/2025
Date last updated
21/02/2025
Date data sharing statement initially provided
21/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 1 Study to Investigate ABS-101 in Healthy Adult Participants
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 First-in-Human Study of Single Ascending Doses of ABS-101 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Adult Participants
Secondary ID [1] 313591 0
Absci Pty Ltd Study ABS101-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Inflammatory Disease 336417 0
Condition category
Condition code
Oral and Gastrointestinal 332939 332939 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study evaluates the single-dose administration of ABS-101 or matched placebo, administered subcutaneously (SC) at 4 dose levels (150, 300, 600 and 1000 mg) and intravenously (IV) at 1 dose level at 300 mg which will be in parallel with the 1000 mg SC dose..

Each cohort will consist of 8 participants who will each receive a single dose of investigational drug or matched placebo. Healthy volunteers will stay in the clinical research unit for a period of 4 days in total, including admission on the day before dosing, and 3 days observation following administration of study intervention. Each of the cohorts will be followed-up afterwards for safety.

Safety, tolerability, and available PK data will be reviewed by the Safety Review Committee (SRC) for dose escalation by evaluating adverse events and laboratory values.
Intervention code [1] 330374 0
Treatment: Drugs
Comparator / control treatment
Matching placebo: The placebo contains matched solvent with no active ingredient
Control group
Placebo

Outcomes
Primary outcome [1] 340549 0
Integrated safety evaluation assessed as a composite primary outcome.
Timepoint [1] 340549 0
Clinical laboratory tests (haematology and clinical chemistry) will be assessed at Screening, and on Days -1, 1 (day of dosing), 2 (1 day post dose), 3 (2 days post-dose), 4 (3 days post dose), 8, 15, 29, 60, 90, 120, 180 and every 60 days from Day 180 until end of study and at the end of study visit. Clinical laboratory test (urinalysis) will be performed at Screening, on Days -1, 4, 15, 29, 90 180 and at the end of study visit. Vital signs will be assessed at Screening, on Days -1, 1, 2, 3, 4, 6, 8, 15, 22, 29, 60, 90, 120, 180 and every 60 days from Day 180 until end of study and at the end of study visit. A complete physical examination will be assessed at screening and end of study visit. A targeted physical examination will be assessed on Days -1, 1, 2, 3, 4, 6, 8, 15, 22, 29, 60, 90, 120, 180, every 60 days until end of study and at the end of study visit. 12-lead ECG will be assessed at Screening, on Days -1, 1, 2, 3, 4, 6, 8, 15, 22, 29, 60, 90, 180, every 60 days until end of study and at the end of study visit. AEs and SAEs will be monitored at all timepoints.
Secondary outcome [1] 444421 0
Pharmacodynamic profile
Timepoint [1] 444421 0
Blood samples collected at pre-dose and 12 hours post-dose, and on days 2, 4, 8, 15, 22, 29, 60, 90, 120, 180 and every 60 days from Day 180 until end of study and at the end of study visit (day 300).
Secondary outcome [2] 444420 0
Pharmacokinetic profile
Timepoint [2] 444420 0
Blood samples collected at pre-dose, 0.5, 1, 4, and 8, hours post-dose, and on Days 2, 3, 4, 6, 8, 15, 22, 29, 60, 90, 120, 180 and every 60 days from Day 180 until end of study and at the end of study visit (day 300),
Secondary outcome [3] 444422 0
Immunogenicity profile
Timepoint [3] 444422 0
Blood samples collected at Screening and on days 4, 8, 15, 29, 60, 90, 120, 180 and every 60 days from Day 180 until end of study (day 300).

Eligibility
Key inclusion criteria
• Must be capable of giving a signed informed consent
• Participants in good health based on medical history, physical examinations, vital signs, 12-lead ECGs, clinical laboratory tests as determined by the Investigator
• Body Mass Index (BMI) within the range 18 to 32 kg/m2 (inclusive), and total body weight more than 60 kg
• Adhere to highly effective contraception or are proven post-menopausal or unable to bear children.
• Must have negative drug, nicotine and alcohol test results.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Any clinical significant abnormalities in laboratory test results or diagnostic assessments deemed clinically significant by the investigator
• History of liver diseases, Gilbert’s syndrome, or abnormal liver function
• Exposure to anti-TL1A or any anti-TL1A therapy
• Positive pregnancy test at Screening, Day -1 and throughout study
• Positive serology test for HIV, Hepatitis B or Hepatitis C
• Pre-existing ADA against ABS-101 at Screening

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)
Allocation concealment in a sealed envelope containing the study intervention assignment for each participant and will be provided to the investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
No efficacy endpoints will be evaluated therefore no sample size calculations were carried out. Cohort numbers are based on historical information and account for possible drop-outs during the study.
All variables will be analyzed using descriptive statistical methods. For continuous data, summary statistics will include the number of observations (n), the arithmetic mean, the arithmetic standard deviation (SD), the median, the minimum (min), and the maximum (max). In addition, log-normally distributed data (e.g., PK concentrations and parameters) will be presented using the geometric mean, the geometric SD, and the geometric coefficient of variation expressed as a percentage (CV%). For categorical data, the frequency counts and percentages will be presented. For the calculation of summary statistics and statistical analysis, unrounded data will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
15/08/2025
Actual
Date of last data collection
Anticipated
15/06/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27573 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 43687 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 318060 0
Commercial sector/Industry
Name [1] 318060 0
Absci Pty Ltd
Country [1] 318060 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Absci Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320413 0
None
Name [1] 320413 0
Address [1] 320413 0
Country [1] 320413 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316710 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316710 0
Ethics committee country [1] 316710 0
Australia
Date submitted for ethics approval [1] 316710 0
05/03/2025
Approval date [1] 316710 0
Ethics approval number [1] 316710 0

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

Contacts
Principal investigator
Name 138750 0
Dr Michael Wong
Address 138750 0
Nucleus Network Pty Ltd, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, 3004, Victoria
Country 138750 0
Australia
Phone 138750 0
+61 737072720
Fax 138750 0
Email 138750 0
[email protected]
Contact person for public queries
Name 138751 0
Dr. Michael Wong
Address 138751 0
Nucleus Network Pty Ltd, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, 3004, Victoria
Country 138751 0
Australia
Phone 138751 0
+61 737072720
Fax 138751 0
Email 138751 0
[email protected]
Contact person for scientific queries
Name 138752 0
Dr. Michael Wong
Address 138752 0
Nucleus Network Pty Ltd, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, 3004, Victoria
Country 138752 0
Australia
Phone 138752 0
+61 737072720
Fax 138752 0
Email 138752 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No individual data will be released in any form



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.