A Phase 1, double-blind, randomized study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of single dose and multiple doses of CG-0416 in healthy participants. HongKong Curegene Innovation Co. Limited is developing the study drug CG-0416 as a potential new treatment for overweight and obesity. The purpose of this research is to investigate the safety, tolerability (if any side effects occur), pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body), of single and multiple oral doses of a study drug called CG-0416.
Male and female participants aged 18 to 60 years, inclusive, at the time of screening.
BMI of ≥ 18 kg/m2 to ≤ 32 kg/m2 for SAD and ≥ 21 kg/m2 to ≤ 35 kg/m2 for MAD at screening, and body weight > 50 kg for SAD and MAD.
Participants will be assessed to be in good health by the investigator, such as no clinically relevant abnormalities that will affect participant safety in the opinion of the investigator based on medical history, physical examination, clinical laboratory assessments (hematology, serum chemistry, coagulation, urinalysis, TH), and 12-lead ECG.
LDL-C > 1.8 mmol/L (70 mg/dL) in SAD, LDL-C > 2.6 mmol/L (100 mg/dL) in MAD.
Clinically significant infection and/or cardiovascular, hematologic, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunologic, dermatologic, neurologic, current or history of ADHD, anxiety or depression, or psychiatric disease at screening that, or its treatment, may have interfered with the conduct of the study (e.g., study procedure compliance, safety assessment, study results interpretation) or, in the judgment of the investigator, will have placed the participant at an unacceptable risk if participating in the study.
Clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, psychiatric or cardiovascular disease) within 6 months before screening.
Thyroid diseases: a) active hyperthyroidism; b) TSH >7 IU/L with symptoms of hypothyroidism or >10 IU/L without symptoms.
Diagnosis of type 1 or 2 diabetes or other autoimmune diabetes (fully resolved gestational diabetes will be permitted).
Sequential
CG-0416
DrugCG-0416 is a novel selective, liver-directed thyroid hormone receptor beta (THR-β) agonist, given orally once daily.
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Treatment groupsSee each treatment group below.
To determine number of participants with treatment-related adverse events as assessed by CTCAE v6.0 of single dose and multiple doses of CG-0416 in healthy participants.
Number of Incidence and frequency of adverse events (AEs) / SAEs possibly or probably related to study drug.
To determine the safety and tolerability of single dose and multiple doses of CG-0416 in healthy participants
Concentration changes from baseline in clinical laboratory safety tests: thyroid hormones \[TH\] , thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4)\], follicle-stimulating hormone (FSH), luteinizing hormone, estradiol, testosterone, and free testosterone.
To determine the safety and tolerability of single dose and multiple doses of CG-0416 in healthy participants.
Baseline and placebo-corrected QTcF (ΔΔQTcF).
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last).
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Area under the concentration-time curve from time 0 to theoretical infinity (AUC0-inf).
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
peak concentration (Cmax).
To define pharmacokinetics (PK) profile of CG-0416 and its active metabolite CG-0400
Time to peak concentration (Tmax).
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