Back to resultsA Study of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia
Primary Purpose
NASH - Nonalcoholic Steatohepatitis
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
ALG-055009
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis
Eligibility Criteria
Inclusion Criteria for Healthy Subjects:
- Male and Female between 18 and 55 years old
- BMI 18.0 to 32.0 kg/m^2
Inclusion Criteria for Subjects with Mild Hyperlipidemia:
- Male and Female between 18 and 65 years old
- BMI 18.0 to 35.0 kg/m^2
- 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:
- 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
- Subjects with Hepatitis A, B, C or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
- 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)
- Subjects with history of thyroid disorder or abnormal thyroid function tests at screening or known sensitivity to thyroid medications
- Subjects receiving, or urgently requiring, any lipid lowering therapy
Sites / Locations
- Biotrial
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ALG-055009
Placebo
Arm Description
Oral dose(s) of ALG-055009 in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days
Oral dose(s) of placebo in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Secondary Outcome Measures
Maximum Plasma Concentration [Cmax]
Pharmacokinetic parameters of ALG-055009 in plasma
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-055009 in plasma
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of ALG-055009 in plasma
Half-life [t1/2]
Pharmacokinetic parameters of ALG-055009 in plasma
Minimum Plasma Concentration [Cmin]
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
Full Information
NCT ID
NCT05090111
First Posted
October 11, 2021
Last Updated
September 21, 2023
Sponsor
Aligos Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT05090111
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
June 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aligos Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALG-055009
Arm Type
Experimental
Arm Description
Oral dose(s) of ALG-055009 in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral dose(s) of placebo in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days
Intervention Type
Drug
Intervention Name(s)
ALG-055009
Intervention Description
Single or multiple doses of ALG-055009
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single or multiple doses of Placebo
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time Frame
Up to 14 days for Part 1
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time Frame
Up to 28 days for Part 2
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time Frame
Up to 35 days for Part 3
Secondary Outcome Measure Information:
Title
Maximum Plasma Concentration [Cmax]
Description
Pharmacokinetic parameters of ALG-055009 in plasma
Time Frame
Predose (between -0.25 hours and 0 hours) up to 35 Days
Title
Area under the concentration time curve [AUC]
Description
Pharmacokinetic parameters of ALG-055009 in plasma
Time Frame
Predose (between -0.25 hours and 0 hours) up to 35 Days
Title
Time to maximum plasma concentration [Tmax]
Description
Pharmacokinetic parameters of ALG-055009 in plasma
Time Frame
Predose (between -0.25 hours and 0 hours) up to 35 Days
Title
Half-life [t1/2]
Description
Pharmacokinetic parameters of ALG-055009 in plasma
Time Frame
Predose (between -0.25 hours and 0 hours) up to 35 Days
Title
Minimum Plasma Concentration [Cmin]
Description
Pharmacokinetic parameters of ALG-055009 in plasma
Time Frame
Predose (between -0.25 hours and 0 hours) up to 35 Days
Title
Change in lipid / lipoprotein levels from baseline through Day 28 in Multiple Dose in Subjects with Mild Hyperlipidemia
Time Frame
Screening, Day -1 to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Healthy Subjects:
Male and Female between 18 and 55 years old
BMI 18.0 to 32.0 kg/m^2
Inclusion Criteria for Subjects with Mild Hyperlipidemia:
Male and Female between 18 and 65 years old
BMI 18.0 to 35.0 kg/m^2
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:
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
Subjects with Hepatitis A, B, C or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
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)
Subjects with history of thyroid disorder or abnormal thyroid function tests at screening or known sensitivity to thyroid medications
Subjects receiving, or urgently requiring, any lipid lowering therapy
Facility Information:
Facility Name
Biotrial
City
Rennes
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Study of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia
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