A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamic… (NCT04536337) | Clinical Trial Compass
CompletedPhase 1
A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
The goal of this clinical trial is to learn if ALG-000184 is safe, well-tolerated, and works to treat chronic hepatitis B virus (HBV) infection. The main questions it aims to answer are:
Is ALG-000184 safe and well-tolerated when given alone or with entecavir (a standard HBV treatment)? Does ALG-000184 reduce HBV viral levels in the blood of patients with chronic hepatitis B? How does the body process ALG-000184 (pharmacokinetics)?
Researchers will compare ALG-000184 to placebo (a look-alike substance that contains no drug) to see if ALG-000184 works better at reducing hepatitis B viral markers.
The study has five parts:
Parts 1 and 2: Healthy volunteers will receive single or multiple doses of ALG-000184 or placebo Part 3: Patients with chronic hepatitis B will receive ALG-000184 or placebo daily for 28 days Part 4: Patients with chronic hepatitis B will receive ALG-000184 or placebo combined with entecavir for 12 weeks (may be extended up to 96 weeks) Part 5: Additional groups of patients with chronic hepatitis B will receive ALG-000184 with entecavir for 12 weeks (may be extended up to 96 weeks)
Participants will:
Take study medication orally as directed Visit the clinic regularly for blood tests, physical examinations, and other safety assessments Have their HBV viral markers measured to determine if the treatment is working
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Female subjects must have a negative serum pregnancy test at screening
✓. Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria
✓. Male or female between 18 and 55 years of age, extremes included.
✓. 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 must have a BMI of 18.0 to 35.0 kg/m2, extremes included.
✓.CHB subjects who at screening, have not received treatment with an approved or investigational medicine, or have never received treatment with HBV antiviral medicines
✓.Subjects must be 18 to 65 years of age, extremes included.
✓.Subjects must have a BMI of 18.0 to 35.0 kg/m2, extremes included
Exclusion criteria
✕. 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
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: up to 8 days for Part 1
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: up to 21 days for Part 2
3
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: up to 112 days for Part 3
4
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
✕. 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.
✕. Subjects with a history of clinically significant drug allergy
✕. Subject with a current history of clinically significant (as determined by investigator) skin disease requiring intermittent or chronic treatment
✕. Excessive use of alcohol, defined as regular consumption of ≥14 standard drinks/week for women and ≥21 standard drinks/week for men
✕. Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
✕. Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow up.
✕. Positive alcohol or cotinine test at screening and Day -1.