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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06740474




Registration number
NCT06740474
Ethics application status
Date submitted
13/12/2024
Date registered
18/12/2024
Date last updated
7/02/2025

Titles & IDs
Public title
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants
Scientific title
A Phase 1a, Blinded, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Single- and Multiple-Ascending Doses of ABI-6250 in Healthy Subjects
Secondary ID [1] 0 0
ABI-6250-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis Delta Virus 0 0
Hepatitis D 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABI-6250
Treatment: Drugs - Placebo

Experimental: Part A: SAD Cohorts 1-5, ABI-6250 -

Placebo comparator: Part A: SAD Cohorts 1-5, Placebo -

Experimental: Part A: SAD Food Effect Cohort 6 or 7: ABI-6250 -

Placebo comparator: Part A: SAD Food Effect Cohort 6 (if applicable): Placebo -

Experimental: Part B: MAD Cohorts 1-4, ABI-6250 -

Placebo comparator: Part B: MAD Cohorts 1-4, Placebo -


Treatment: Drugs: ABI-6250
Single dose (SAD) or once or twice daily dosing over 10 days (MAD)

Treatment: Drugs: Placebo
Single dose (SAD) or once or twice daily dosing over 10 days (MAD)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with AEs, premature treatment discontinuation due to AEs and abnormal laboratory results
Timepoint [1] 0 0
From enrollment to 10 days after the last dose, at pre-specified timepoints
Primary outcome [2] 0 0
Area Under the Plasma Concentration Time Curve (AUC) of ABI-6250
Timepoint [2] 0 0
From enrollment to 10 days after the last dose, at pre-specified timepoints
Primary outcome [3] 0 0
Maximum Observed Plasma Concentration (Cmax) of ABI-6250
Timepoint [3] 0 0
From enrollment to 10 days after the last dose, at pre-specified timepoints
Primary outcome [4] 0 0
Time to Cmax (Tmax) of ABI-6250
Timepoint [4] 0 0
From enrollment to 10 days after the last dose, at pre-specified timepoints
Primary outcome [5] 0 0
Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250
Timepoint [5] 0 0
From enrollment to 10 days after the last dose, at pre-specified timepoints
Primary outcome [6] 0 0
Apparent Systemic Clearance (CL/F) of ABI-6250
Timepoint [6] 0 0
From enrollment to 10 days after the last dose, at pre-specified timepoints
Primary outcome [7] 0 0
Apparent Volume of Distribution (Vz/F) of ABI-6250
Timepoint [7] 0 0
From enrollment to 10 days after the last dose, at pre-specified timepoints
Primary outcome [8] 0 0
Dose normalized AUCs and Cmax of ABI-6250
Timepoint [8] 0 0
From enrollment to 10 days after the last dose, at pre-specified timepoints
Secondary outcome [1] 0 0
Comparison of plasma AUC between fasted and fed treatments
Timepoint [1] 0 0
From enrollment to 10 days after the last dose, at pre-specified timepoints
Secondary outcome [2] 0 0
Comparison of AUC between fasted and fed treatments
Timepoint [2] 0 0
From enrollment to 10 days after the last dose, at pre-specified timepoints

Eligibility
Key inclusion criteria
* Participant has a body mass index (BMI) between =18.0 and <32.0 kg/m2 and is in good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
* Female participants must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day-1 or Day 1 (predose).
* Participants must agree to comply with protocol-specified contraceptive requirements.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Current infection of human immunodeficiency virus (HIV), hepatitis B virus, (HBV), hepatitis C virus (HCV) or acute hepatitis A virus (HAV).
* History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or condition known to interfere with the absorption /distribution/ elimination of drugs.
* History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson Syndrome, urticaria, or multiple drug allergies.
* History of persistent alcohol abuse or illicit drug abuse within 3 years prior to screening.
* Has participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 half-lives before screening, whatever is longer.

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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Assembly Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to assess safety, tolerability, and pharmacokinetics of single ascending doses (SAD) and multiple-ascending doses (MAD) of ABI-6250 in healthy participants. Effect of food will also be evaluated in Part A.
Trial website
https://clinicaltrials.gov/study/NCT06740474
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Assembly Biosciences
Address 0 0
Country 0 0
Phone 0 0
833-509-4583
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06740474