A Study of ALG-055009 in Healthy Volunteers and Subjects With Hyperlipidemia
Phase 1
Completed
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05090111
- Lead Sponsor
- Aligos Therapeutics
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral dose(s) of placebo in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days ALG-055009 ALG-055009 Oral dose(s) of ALG-055009 in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Up to 35 days for Part 3 The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
- Secondary Outcome Measures
Name Time Method Maximum Plasma Concentration [Cmax] Predose (between -0.25 hours and 0 hours) up to 35 Days Pharmacokinetic parameters of ALG-055009 in plasma
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
Half-life [t1/2] 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
Trial Locations
- Locations (1)
Biotrial
🇫🇷Rennes, France