A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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 (Part B).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

Inclusion Criteria:

• Part A Only

• Has body mass index (BMI) ≥18 kg/m^2 and ≤28 kg/m^2

• Has normal 12-lead electrocardiogram (ECG)

• Part B 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 Criteria:

• Parts A and B:

• 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) ≤60 mL/min/1.73m^2 at screening

• Part B 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