Clinical trial NCT05090111: A Study of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia
Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia, and an Open-Label Assessment of Bioavailability and Food-effect in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NASH - Nonalcoholic Steatohepatitis
Lead sponsor: Aligos Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 14 days for Part 1
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 28 days for Part 2
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 35 days for Part 3
Secondary outcomes:
measure: Maximum Plasma Concentration [Cmax]
timeFrame: Predose (between -0.25 hours and 0 hours) up to 35 Days
measure: Area under the concentration time curve [AUC]
timeFrame: Predose (between -0.25 hours and 0 hours) up to 35 Days
measure: Time to maximum plasma concentration [Tmax]
timeFrame: Predose (between -0.25 hours and 0 hours) up to 35 Days
measure: Half-life [t1/2]
timeFrame: Predose (between -0.25 hours and 0 hours) up to 35 Days
measure: Minimum Plasma Concentration [Cmin]
timeFrame: Predose (between -0.25 hours and 0 hours) up to 35 Days
measure: Change in lipid / lipoprotein levels from baseline through Day 28 in Multiple Dose in Subjects with Mild Hyperlipidemia
timeFrame: Screening, Day -1 to Day 28
Other outcomes:
Locations:
city: Rennes
country: France
facility: Biotrial
Study officials:
References: