Gout
Conditions
Interventions
ABP-671 group:The investigational product will be administered in an escalating dose regimen as follows: 0.5 mg on Days 1-3, 1 mg on Days 4-6, 4 mg on Days 7-9, and 8 mg on Days 10-12, with a dosing f
Placebo group:The placebo group will follow an identical dosing schedule (both in amount and frequency) as the investigational drug group
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria Subjects must meet all the following inclusion criteria to be eligible for this trial: 1.Voluntarily sign a written informed consent form before the initiation of activities related to the trial, understand the procedures and methods of the trial, and be willing to complete the trial in strict accordance with the clinical trial protocol; 2.Males or females aged between 18 (inclusive) and 45 (inclusive) years at the time of signing the informed consent form; 3.Male subject weight >= 50 kg, female subject weight >= 45.0 kg; BMI (BMI, calculated as BMI = weight/height squared, Unit: kg/m2) is between 19.0 (inclusive) and 26.0 (inclusive) kg/m2; 4.Blood uric acid (UA) level at screening is between 240 µmol/L (inclusive) and 420 µmol/L (inclusive) and the subject has no medical history of gout; 5.Those who have no family planning from the time of signing the informed consent form to within 3 months after the last dose and who volunteer to use effective contraceptive methods and have no plan as sperm or egg donor. 6.Be able to communicate well with the investigators and understand and comply with the requirements of the trial.
Exclusion criteria
Exclusion criteria: Exclusion criteria Subjects who meet any of the following criteria will be excluded from the trial: 1.Known to have a history of allergies to ABP-671 or its related excipients or equivalent drugs, or have allergies to other drugs, foods and the environment, or be allergic constitution, or have a history of atopic allergic disease (e.g. asthma, urticaria, eczematous dermatitis, etc.); 2.Physical examination, vital signs, electrocardiogram (ECG), abdomen ultrasound (liver, gallbladder, pancreas, spleen, kidneys and bilateral ureters), chest PA & LAT x-ray examination, laboratory tests and other examinations are abnormal but clinically significant (subject to the clinician's judgment); 3.Those with chronic diseases, including but not limited to the respiratory system, digestive system, cardiovascular system, urological system, blood system, endocrine system, the immune system, etc.; 4.Those with electrolyte metabolic disorders such as hyperkalemia, hypokalemia, hypermagnesaemia, hypomagnesaemia, hypercalcemia, hypocalcemia, etc. and those with clinical significance judged by the investigator; 5.Those who had other risk factors for ventricular tachycardia with Torsades de Pointes (twisting of the points), or have a family history of short QT syndrome or long QT syndrome, or whose first degree relatives (i.e., biological parents, siblings, or children) in a family have sudden death of unknown cause in their youth (= 450 ms [Fridericia formula QTcF=QT/ (RR^0.33) calculation], or QRS>= 120 ms, or PR>= 200 ms, and with abnormality but clinical significance judged by the investigator; 7.Those with positive results at screening for any of the hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody, and treponema pallidum-specific antibody tests; 8.Those who had participated in a clinical trial of any drug or medical device within 3 months before the first dose, or who were in the follow-up visit period of a clinical study or within 5 half-lives of a trial drug before screening, whichever is longer; 9.Those who had undergone surgery within 6 months before the first dose, according to the investigator's judgment, would affect absorption, distribution, metabolism, or excretion of the trial drug; or who had undergone surgery within 4 weeks before the first dose; or who plan to undergo surgery during the trial; 10.Those who have used any medication (including Chinese herbs, health care products, etc.) within 14 days before the first dose of the trial drug or plan to take it during the trial (except the trial drug, placebo and sodium bicarbonate tablet in this trial); 11.Those who have donated blood or a large amount of blood loss (> 400 mL) within 3 months before the first dose, or who have received a blood transfusion or used blood products, or who intend to donate blood or blood components during the trial or within 3 months after the end of the trial; 12.Those with a history of drug abuse (including repeated and substantial use of various narcotic drugs and psychotropic substances for non-medical purposes) or positive for any of urine drug abuse screens; 13.Heavy smokers or those who smoked more than 5 cigarettes per day within 3 months before the first dose, or those who are unable to abstain from any tobacco products during the trial; 14.Alcoholics or regular drinkers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline- and placebo-corrected QTcF; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiogram (ECG) parameters;Plasma PK;Safety and tolerability endpoints; | — |
Countries
China
Contacts
Public ContactLi Haiyan
Peking University Third Hospital
Outcome results
None listed