The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-HSD in healthy participants (Part A) and multiple doses of ALN-HSD in patients with NASH (Parts B and C).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6
Clinical Trial Site
Fleming Island, Florida, United States
Clinical Trial Site
Marrero, Louisiana, United States
Clinical Trial Site
Baltimore, Maryland, United States
Parts A and B: Frequency of Adverse Events
Time frame: Part A: Up to 3.5 months; Part B: up to 12.5 months
Part C: Change from Baseline of Liver Hydroxysteroid 17β Dehydrogenase 13 (HSD17B13) Messenger Ribonucleic Acid (mRNA)
Time frame: Baseline and Month 6
Part A: Area Under the Plasma Concentration-time Curve (AUC) for ALN-HSD and Potential Metabolites
Time frame: Day 1 predose and up to 48 hours postdose
Pat A: Maximum Plasma Concentration (Cmax) for ALN-HSD and Potential Metabolites
Time frame: Day 1 predose and up to 48 hours postdose
Part A: Fraction Excreted in Urine (fe) of ALN-HSD and Potential Metabolites
Time frame: Day 1 up to 24 hours postdose
Part B: Plasma Concentrations of ALN-HSD and Potential Major Metabolite(s)
Time frame: Day 1 and Month 3 predose and up to 4 hours postdose
Part B: Change from Baseline of Liver HSD17B13 mRNA
Hepatic HSD17B13 mRNA will be measured by quantitative reverse-transcription polymerase chain reaction using ribonucleic acid (RNA) isolated from liver biopsy.
Time frame: Predose and up to 9 months postdose
Part C: Frequency of Adverse Events
Time frame: Up to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Trial Site
Hermitage, Tennessee, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
Brussels, Belgium
Clinical Trial Site
Sofia, Bulgaria
Clinical Trial Site
Balçova, Turkey (Türkiye)
...and 3 more locations