Phase
Condition
N/ATreatment
RBD5044
Placebo
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria are met:
Willing to comply with protocol required visit schedule and visit requirements andprovide written informed consent.
Male and female subjects, aged 18 to 65 years (inclusive).
Body mass index between 18 and 32 kg/m2, inclusive.
Fasting TG ≥ 0.9 mmol/L (80 mg/dL) and ≤ 3.4 mmol/L (300 mg/dL) at screening.
Fasting LDL-C < 4.9 mmol/L (<190 mg/dL) at screening.
Healthy as determined by pre-study medical history, physical examination, clinicallaboratory assessments, and 12-lead electrocardiogram (ECG).
Satisfy one of the following:
Females: must be non-pregnant and non-lactating; surgically sterile,post-menopausal, abstinent, or if engaged in sexual relations of child-bearingpotential, the subject is using an acceptable contraceptive method (refer toSection 4.6.3) for four weeks before, during, and for at least 6 months afterthe last dose of study drug administration.
Males: must be surgically sterile, abstinent, or if engaged in sexual relationsof child-bearing potential, the subject is utilizing an acceptablecontraceptive method (refer to Section 4.6.3)) during and for at least 6 monthsafter the last dose of study drug administration.
- Non-smokers and non-nicotine users for at least 90 days before screening
Exclusion
Exclusion Criteria:
A subject meeting any of the following exclusion criteria will not be allowed to participate in this study:
Any uncontrolled or serious disease, or any medical or surgical condition, mayinterfere with participation in the clinical study and/or put the subject atsignificant risk (according to the investigator's judgment) if he/she participatesin the clinical study.
History or presence of cardiovascular disease (including peripheral artery andcerebrovascular disease).
Systolic blood pressure (SBP) > 140 mmHg and/or diastolic blood pressure (DBP) > 90mmHg after 10 minutes of supine rest, unless determined by the investigator to benot clinically relevant.
Diagnosis of diabetes mellitus.
Received any medication or nutraceutical to alter serum lipids within 30 days beforescreening.
Active serious mental illness or psychiatric disorder, including but not limited toschizophrenia, bipolar disorder, or severe depression, which require currentpharmacological intervention.
Alanine aminotransferase (ALT) and/or total bilirubin are above the upper limit ofnormal reference range (ULN); no investigator discretion and repeat assessments areallowed.
Aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyltransferase (GGT) > 2 × ULN (no investigator discretion); or, if AST, ALP, or GGT >ULN, but ≤ 2 × ULN and considered clinically relevant by the investigator.
Used prescription drugs within 14 days or 7 half-lives (whichever is longer) beforethe first dose of study drug.
Used over-the-counter medication, excluding routine vitamins, within 7 days beforethe first dose of the study drug, unless determined by the investigator to be notclinically relevant, and unlikely to impact blood lipids level.
Received an investigational product within 30 days or 7 half-lives (whichever islonger) before the first dose of the study drug or are in the follow-up of anotherclinical study. If subjects used advanced therapy (ASO/siRNA/gene therapy/celltherapy), it should be judged by the investigator.
Hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), syphilisinfection, or positive hepatitis B surface antigen (HBsAg), hepatitis B coreantibody (HBcAb), hepatitis C virus antibody (HCVAb), HIV antibody (HIVAb),treponema pallidum antibody (TP-Ab) at screening.
Clinically significant illness within 7 days before the first dose of the studydrug.
Consume more than 14 (female) or 21 (male) units of alcohol per week (unit: 1 glassof wine [125 mL] = 1 measure of spirits = ½ pint of beer) within the 12 monthsbefore screening or positive screen for alcohol abuse.
History or clinical evidence of drug abuse within the 12 months before screening orpositive screen for drug abuse. Drug abuse is defined as compulsive, repetitive,and/or chronic use of drugs or other substances with or without problems related totheir use and/or where stopping or a dose reduction will lead to withdrawalsymptoms.
Donated more than 500 mL of blood within 90 days before the first dose of the studydrug.
History of multiple drug allergies or history of allergic reaction to anoligonucleotide or N-acetylgalactosamine (GalNAc).
History of intolerance to subcutaneous (SC) injection or relevant abdominal scarring (surgical, burns, etc.).
Any conditions which would make the subject unsuitable for enrollment or couldinterfere with the subject's participation in or completion of the study in theopinion of the investigator.
Study Design
Connect with a study center
Q-Pharm Pty Limited
Brisbane,
AustraliaSite Not Available

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