A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)
Reason given: Study ALN-HSD-001 was terminated due to business reasons and changes in the development strategy of the product. No safety issues were found.
Key facts
- Where
- Baltimore, Fleming Island, Hermitage, Marrero, and San Antonio, United StatesSee the 5 sites
- Phase
- Phase 1
Where in United States
- BaltimoreBaltimore, United StatesNo longer taking part
- Fleming IslandFleming Island, United StatesNo longer taking part
- HermitageHermitage, United StatesNo longer taking part
- MarreroMarrero, United StatesNo longer taking part
- San AntonioSan Antonio, United StatesNo longer taking part
Trial details
- Who runs it
- Alnylam Pharmaceuticals
- Trial code
- NCT04565717
- Record updated
- 17 May 2024
- Original description
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).Read full original descriptionShow less
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 3-Part Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-HSD in Healthy Adult Subjects and Multiple Dose ALN-HSD in Adult Patients With Nonalcoholic Steatohepatitis (NASH)
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).
Inclusion: Part A Only; Has body mass index (BMI) ≥18 kg/m\^2 and ≤28 kg/m\^2; Has normal 12-lead electrocardiogram (ECG); Parts B and C Only:; Has BMI ≥18 kg/m\^2 and ≤40 kg/m\^2; Has a diagnosis of NASH documented in the patient's medical history or a clinical suspicion of NASH based on defined study criteria; Has screening liver biopsy with NASH activity score (NAS) score of ≥3 per NASH Clinical Research Network (CRN) criteria.
Exclusion: Parts A, B and C:; Has any clinical safety laboratory result considered clinically significant and unacceptable by the Investigator; Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection; Has known history or evidence of drug abuse, within 12 months prior to screening; Has evidence of other forms of known chronic liver disease; Has recently received an investigational agent; Has any uncontrolled or serious disease, medical or surgical condition that my interfere with participation or data interpretation; Has excessive alcohol intake for ≥ 3 months during past year; Has history of intolerance to SC injection(s); Has international normalized ratio (INR) >1.2; Has platelet count <140x10\^9/L; Part A Only; Has systolic blood pressure (BP) >140 mmHg and diastolic >90 mmHg; Has used certain prescription drugs within last 14 days prior to screening; Has used certain over the counter (OTC) medication within 7 days prior to screening; Has estimated glomerular filtration rate (GFR) <90 mL/min/1.73m\^2 at screening; Parts B and C Only; Has abnormal ECG; Has changes in certain prescription medications defined in the protocol within the specified timeframe prior to screening; Has GFR<45ml/min/1.73m\^2.