Biotrial
Rennes, France
NCT Number: NCT05090111
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Rennes, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Healthy Subjects:
Inclusion criteria
for Subjects with Mild Hyperlipidemia:
Exclusion criteria
for All Subjects:
Single or multiple doses of ALG-055009
Single or multiple doses of Placebo
Time frame: Up to 14 days for Part 1
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Up to 28 days for Part 2
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Up to 35 days for Part 3
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Pharmacokinetic parameters of ALG-055009 in plasma
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Pharmacokinetic parameters of ALG-055009 in plasma
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Pharmacokinetic parameters of ALG-055009 in plasma
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Pharmacokinetic parameters of ALG-055009 in plasma
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Pharmacokinetic parameters of ALG-055009 in plasma
Time frame: Screening, Day -1 to Day 28
Aligos Therapeutics
Industry
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
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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