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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04536337




Registration number
NCT04536337
Ethics application status
Date submitted
28/08/2020
Date registered
2/09/2020
Date last updated
28/04/2023

Titles & IDs
Public title
A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
Scientific title
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Orally Administered ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single-Ascending Doses (Part 1) and Multiple-Ascending Doses in Healthy Volunteers (Part 2), and Multiple Doses in Subjects With Chronic Hepatitis B (Part 3)
Secondary ID [1] 0 0
ALG-000184-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 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 - ALG-000184
Treatment: Drugs - Placebo
Treatment: Drugs - Entecavir

Experimental: ALG-000184 - Oral tablet(s) of ALG-000184 in HV or CHB subjects once daily for up to 4 weeks

Placebo comparator: Placebo - Oral tablet(s) of placebo in HV or CHB subjects once daily for up to 4 weeks

Active comparator: Entecavir in combination with ALG-000184 -


Treatment: Drugs: ALG-000184
Single or multiple doses of ALG-000184

Treatment: Drugs: Placebo
Single or multiple doses of Placebo

Treatment: Drugs: Entecavir
multiple doses of Entecavir
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timepoint [1] 0 0
up to 8 days for Part 1
Primary outcome [2] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timepoint [2] 0 0
up to 21 days for Part 2
Primary outcome [3] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timepoint [3] 0 0
up to 112 days for Part 3
Primary outcome [4] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timepoint [4] 0 0
Up to 336 days for parts 4 & 5
Secondary outcome [1] 0 0
Maximum Plasma Concentration [Cmax]
Timepoint [1] 0 0
Predose up to 343 Days
Secondary outcome [2] 0 0
Area under the concentration time curve [AUC]
Timepoint [2] 0 0
Predose up to 343 Days
Secondary outcome [3] 0 0
Time to maximum plasma concentration [Tmax]
Timepoint [3] 0 0
Predose up to 343 Days
Secondary outcome [4] 0 0
Half-time [t1/2]
Timepoint [4] 0 0
Predose up to 343 Days
Secondary outcome [5] 0 0
Minimum Plasma Concentration [Cmin]
Timepoint [5] 0 0
Predose up to 343 Days
Secondary outcome [6] 0 0
Change in HBV DNA from baseline through Day 392 in Multiple Dose HBV Infected Patients
Timepoint [6] 0 0
Screening up to Day 392

Eligibility
Key inclusion criteria
Inclusion Criteria for All Subjects:

1. Female subjects must have a negative serum pregnancy test at screening
2. Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria

Inclusion Criteria for Healthy Volunteers:

In addition to inclusion criteria 1-2, the following inclusion criteria also apply to HV's (Parts 1 and 2)
3. Male or female between 18 and 55 years of age, extremes included.
4. Subjects must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 32.0 kg/m2, extremes included.

CHB Subjects:

In addition to inclusion criteria 1-4, the following inclusion criteria also apply to CHB subjects:

All of the Following criteria apply to Part 3 at screening:

5 .Subjects must be 18 to 65 years of age, extremes included.

6.CHB subjects must have a BMI of 18.0 to 35.0 kg/m2, extremes included.

7.CHB subjects who at screening, have not received treatment with an approved or investigational medicine, or have never received treatment with HBV antiviral medicines

All of the following criteria apply to Part 4 Cohorts A & B, unless otherwise specified, at Screening:

8.Subjects must be 18 to 65 years of age, extremes included.

9.Subjects must have a BMI of 18.0 to 35.0 kg/m2, extremes included

10.Subjects must be HBeAg positive (HBeAg =LLOQ and HBeAb negative)

11.Subjects enrolled in Part 4 Cohort A and B must have a history of Chronic Hepatitis B

12. Subjects must have ALT and AST must have =1.2×ULN or =5×ULN

All of the following criteria apply to Part 5 at Screening

13.Subjects must be 18 to 65 years of age, extremes included.

14. Subjects have a BMI of 17.0 to 35.0 kg/m2, extremes included

15.Subjects could belong to any of the following treatment categories: treatment naïve (TN), currently not treated (CNT) , virologically suppressed.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

Exclusion Criteria for All Subjects:

1. Subjects with any previous or current illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject, or pose an additional risk in administering study drug to the subject, or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT syndrome, or history of clinical evidence at screening of significant or unstable cardiac disease etc.
3. Subjects with a history of clinically significant drug allergy
4. Subject with a current history of clinically significant (as determined by investigator) skin disease requiring intermittent or chronic treatment
5. Excessive use of alcohol, defined as regular consumption of =14 standard drinks/week for women and =21 standard drinks/week for men
6. Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection

Exclusion Criteria for Healthy Volunteers (Parts 1 and 2):

In addition to exclusion criteria 1-6, the following exclusion criteria also apply to HV's (Parts 1 and 2)
7. Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow up.
8. Positive alcohol or cotinine test at screening and Day -1.
9. Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m2at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula).

Exclusion Criteria for CHB Subjects (Parts 3, 4, and 5):

All exclusion criteria listed above for healthy volunteers apply also to CHB subjects, except for exclusion Criteria 9 (requirement relative to cotinine).All the following exclusion criteria apply to Parts 3, 4, and 5, unless otherwise specified.
10. Subjects who are positive for anti-HBs antibodies.
11. For HBeAg-positive subjects, they should be negative for anti-HBe antibodies (Parts 4 and 5)
12. Subject with any history or current evidence of hepatic decompensation such as: variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy, or active jaundice (within the last year).
13. History or current evidence of cirrhosis.
14. Subjects with liver fibrosis that is classified as Metavir Score =F3 liver disease
15. Subjects with signs of hepatocellular carcinoma

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 assessing the outcomes
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
336
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Saint Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
Western Health - Footscray
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3011 - Footscray
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Chongqing
Country [2] 0 0
China
State/province [2] 0 0
Guangdong
Country [3] 0 0
China
State/province [3] 0 0
Jilin
Country [4] 0 0
Hong Kong
State/province [4] 0 0
Hong Kong
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Shatin
Country [6] 0 0
Mauritius
State/province [6] 0 0
Quatre Bornes
Country [7] 0 0
Moldova, Republic of
State/province [7] 0 0
Chisinau
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
United Kingdom
State/province [9] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Aligos Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04536337