Status and phase
Conditions
Treatments
About
This will be a single center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study in healthy adult subjects.
Full description
A total of approximately 73 to 89 healthy male and female subjects will be enrolled into this study, it includes two parts:
Part A is single ascending dose stage, approximately 49 to 65 healthy subjects will be enrolled into about eight to ten cohorts. Subjects who meet eligibility criteria at screening will be admitted for baseline evaluations (Day -1). All baseline safety evaluation results must be available prior to dosing. The doses will be progressively escalated, with a sentinel dosing strategy employed for all cohorts.
Part B is multiple ascending dose stage, approximately 24 healthy subjects will be enrolled into about three cohorts. Subjects who meet eligibility criteria at screening will be admitted for baseline evaluations (Day -1). All baseline safety evaluation results must be available prior to dosing. The cohort M1 will be initiated by decision of SRC(safety review committee), then the doses will be progressively escalated.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.
Receiving an investigational agent at the time of enrollment, or within 30 days or 5 half-lifes of enrollment, whichever is longer prior to study drug administration.
Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, COVID-19 vaccine, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. If needed, (i.e., an incidental and limited need of maximum 2 g per day, no more than 3 consecutive days within 2 weeks prior to dosing) paracetamol is acceptable, but must be documented in the Concomitant medications page of the CRF.
Fasting triglyceride concentration >2.8 mmol/L.
A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at Screening or Baseline:
Pregnant or nursing (lactating) women.
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant UNLESS the subject agrees to comply with highly effective, double barrier contraception for the entire duration of the study and for a period of 30 days after the dose of study drug. Fertile males, defined as all males physiologically capable of conceiving offspring UNLESS the subject agrees to comply with highly effective, double barrier contraception for the entire duration of the study and for a period of 30 days after the dose of study drug.
Smokers (use of tobacco products in the previous 1 month). Urine cotinine levels will be measured during screening and at baseline for all subjects. Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine ≥ 500 ng/mL. For light smokers to pass the cotinine test, smoking should be stopped at least 24 hours prior to reporting to the center (i.e., Day -2, early morning). Smoking will not be allowed during the study.
History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays for alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates conducted during screening and/or baseline. Any THC-containing products should not be used at least 7 days prior to screening, and participant needs to abstain any THC-containing products during the trial. Alcohol abuse was defined as consumption of 14 or more standard drinks per week.
A positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test result.
A positive COVID-19 test result.
History of myopathy/myalgia, or susceptible to myopathy/rhabdomyolysis (e.g., hypothyroidism, family history of hereditary myopathy, previous muscle toxicity with HMG-CoA reductase inhibitors or fibrates).
Multiple drug allergies, or history of allergic reactions to rosuvastatin or any components of the study drug.
Donation or loss of more than 400 mL of blood within 3 months prior to study drug administration.
Plasma donation (> 100 ml) within 60 days prior to first dosing.
Hemoglobin levels below 12.0 g/dl at screening.
Recent (within the last 3 years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
Recent (within the last 3 years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated), or cardiac dysfunction or myocardial infarction.
History of significant food allergies (e.g. anaphylactic reactions). Mild (non-anaphylactic, hypersensitivity) food allergies such as lactose intolerance/glucose intolerance are permitted.
Any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The Investigator should make this determination in consideration of the subject's medical history and/or clinical or laboratory evidence of any of the following:
If necessary, laboratory testing may be repeated on one occasion (as soon as possible) prior to randomization, to rule out any laboratory error.
Significant illness resolved within two (2) weeks prior to initial dosing.
Primary purpose
Allocation
Interventional model
Masking
64 participants in 2 patient groups, including a placebo group
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Central trial contact
Jamie Zhang, Master
Data sourced from clinicaltrials.gov
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