Safety, Tolerability, and Pharmacokinetics of ARC-520 Injection, an RNA Interference-Based Therapeutic for the Treatment of Chronic Hepatitis B Virus Infection, in Healthy Volunteers

Clinical Pharmacology in Drug Development

Volumn 6, Issue 4, 2017, Pages 350-362

  Schluep, Thomas ^a   Lickliter, Jason ^b   Hamilton, James ^a   Lewis, David L ^a   Lai, Ching Lung ^c   Lau, Johnson YN ^d   Locarnini, Stephen A ^e   Gish, Robert G ^f   Given, Bruce D ^a  

^a Arrowhead Pharmaceuticals Inc   (United States)

^b Nucleus Network   (Australia)

^c UNIVERSITY OF HONG KONG   (Hong Kong)

^d HONG KONG POLYTECHNIC UNIVERSITY   (Hong Kong)

^e VICTORIAN INFECTIOUS DISEASES REFERENCE LABORATORY   (Australia)

^f STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

hepatitis B; pharmacokinetics; pharmacology; phase 1; RNA interference; RNAi; safety; tolerability; treatment; viral hepatitis; volunteers

Indexed keywords

ANTIVIRUS AGENT; ARC 520; BILE SALT EXPORT PUMP; BILIRUBIN; COMPLEMENT; CREATININE; DIPHENHYDRAMINE; DOXYLAMINE; HISTAMINE; INTERLEUKIN 8; MACROPHAGE INFLAMMATORY PROTEIN 1ALPHA; MONOCYTE CHEMOTACTIC PROTEIN 1; PLACEBO; PROMETHAZINE; RNA; SMALL INTERFERING RNA; SODIUM BILE ACID COTRANSPORTER; UNCLASSIFIED DRUG; ANTIHISTAMINIC AGENT;

ABDOMINAL DISCOMFORT; ADULT; ANIMAL CELL; AREA UNDER THE CURVE; ARTICLE; ATRIOVENTRICULAR BLOCK; CARDIOVASCULAR DISEASE; CATHETER COMPLICATION; CATHETER SITE BRUISE; CHRONIC HEPATITIS B; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONTUSION; DEPRESSED BLOOD PRESSURE; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE SEQUENCE; DRUG EXPOSURE; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRY THROAT; DYSGEUSIA; FAINTNESS; FEMALE; FLUSHING; HEADACHE; HEART PALPITATION; HEMATURIA; HISTAMINE RELEASE; HUMAN; HUMAN CELL; HUMAN EXPERIMENT; HYPEREMIA; HYPERVAGAL SYNDROME; HYPOTENSION; LACERATION; LETHARGY; LIMB PAIN; MALE; MAST CELL DEGRANULATION; MAXIMUM PLASMA CONCENTRATION; MOBITZ TYPE I ATRIOVENTRICULAR BLOCK; MYALGIA; NONHUMAN; NORMAL HUMAN; OCULAR HYPEREMIA; ORAL PARESTHESIA; OROPHARYNX PAIN; PHARMACODYNAMICS; PHARYNGITIS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROPHYLAXIS; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; RAT; RNAI THERAPEUTICS; SINGLE DRUG DOSE; SOMNOLENCE; SORE THROAT; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URINARY CAST; URTICARIA; CLINICAL TRIAL; HALF LIFE TIME; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; PRE-EXPOSURE PROPHYLAXIS; PROCEDURES; RNA INTERFERENCE; YOUNG ADULT;

ADULT; ANTIVIRAL AGENTS; DOUBLE-BLIND METHOD; FEMALE; HALF-LIFE; HEALTHY VOLUNTEERS; HEPATITIS B, CHRONIC; HISTAMINE ANTAGONISTS; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; PRE-EXPOSURE PROPHYLAXIS; RNA INTERFERENCE; YOUNG ADULT;

EID: 85023208957     PISSN: 2160763X     EISSN: 21607648     Source Type: Journal    
DOI: 10.1002/cpdd.318     Document Type: Article

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