NASH - Nonalcoholic Steatohepatitis
Conditions
Brief summary
A Randomized Study of ALG-055009 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses in Healthy Volunteers and Subjects with Hyperlipidemia
Interventions
DRUGALG-055009
Single or multiple doses of ALG-055009
DRUGPlacebo
Single or multiple doses of Placebo
Sponsors
Aligos Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
for Healthy Subjects: 1. Male and Female between 18 and 55 years old 2. BMI 18.0 to 32.0 kg/m\^2 Inclusion Criteria for Subjects with Mild Hyperlipidemia: 1. Male and Female between 18 and 65 years old 2. BMI 18.0 to 35.0 kg/m\^2 3. Subject must be on a stable diet for the 3 months prior to screening with a fasting LDL-C level \>110 mg/dL at screening
Exclusion criteria
for All Subjects: 1. Subjects with any current or previous 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 that could prevent, limit, or confound the protocol specified assessments or study results' interpretation 2. Subjects with Hepatitis A, B, C or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection 3. Subjects with renal dysfunction (e.g., estimated creatinine clearance \<90 mL/min/1.73 m\^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) 4. Subjects with history of thyroid disorder or abnormal thyroid function tests at screening or known sensitivity to thyroid medications 5. Subjects receiving, or urgently requiring, any lipid lowering therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Up to 14 days for Part 1 | The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration time curve [AUC] | Predose (between -0.25 hours and 0 hours) up to 35 Days | Pharmacokinetic parameters of ALG-055009 in plasma |
| Time to maximum plasma concentration [Tmax] | Predose (between -0.25 hours and 0 hours) up to 35 Days | Pharmacokinetic parameters of ALG-055009 in plasma |
| Maximum Plasma Concentration [Cmax] | Predose (between -0.25 hours and 0 hours) up to 35 Days | Pharmacokinetic parameters of ALG-055009 in plasma |
| Minimum Plasma Concentration [Cmin] | Predose (between -0.25 hours and 0 hours) up to 35 Days | Pharmacokinetic parameters of ALG-055009 in plasma |
| Change in lipid / lipoprotein levels from baseline through Day 28 in Multiple Dose in Subjects with Mild Hyperlipidemia | Screening, Day -1 to Day 28 | — |
| Half-life [t1/2] | Predose (between -0.25 hours and 0 hours) up to 35 Days | Pharmacokinetic parameters of ALG-055009 in plasma |
Countries
France
Outcome results
None listed