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Completed

NCT Number: NCT05090111

A Study of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biotrial

Rennes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALG-055009

Drug

Single or multiple doses of ALG-055009

Placebo

Drug

Single or multiple doses of Placebo

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Up to 14 days for Part 1

    The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Up to 28 days for Part 2

    The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Up to 35 days for Part 3

    The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1

Secondary outcomes

  1. Maximum Plasma Concentration [Cmax]

    Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days

    Pharmacokinetic parameters of ALG-055009 in plasma

  2. Area under the concentration time curve [AUC]

    Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days

    Pharmacokinetic parameters of ALG-055009 in plasma

  3. Time to maximum plasma concentration [Tmax]

    Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days

    Pharmacokinetic parameters of ALG-055009 in plasma

  4. Half-life [t1/2]

    Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days

    Pharmacokinetic parameters of ALG-055009 in plasma

  5. Minimum Plasma Concentration [Cmin]

    Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days

    Pharmacokinetic parameters of ALG-055009 in plasma

  6. 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

Sponsors and collaborators

Lead sponsor

Aligos Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2021
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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