Metabolic disease
Conditions
Interventions
all groups:oral drug
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Independent Ethics Committee (IEC)-approved written Informed Consent must be obtained from the participant prior to any study-related procedures; 2. The participant is a healthy non-elderly male or female participant aged 18 to 45 years inclusive (at screening) (part 1 and 2) or hyperuricemia male and female (Part 3) participant aged 18 to 45 years inclusive (at screening); 3. Participants have a Body Mass Index (BMI) range of 18.5 – 26.0 kg/m2, inclusive. The male participant weighs at least 50 kg (at screening) and the female participant weighs at least 45 kg (at screening); 4. Female subjects must satisfy one of the following: (1) Agreed not to be pregnant for 28 days after the study and the last time the drug was taken. (2) The serum HCG must be negative before the drug is given. (3) If sexual activity is active, agree to continue the use of effective birth control throughout the study period and 28 days after the last medication, starting with screening. Efficient birth control measures include, but are not limited to: (1) Continuous and correct use of established oral contraception for the suppression of ovulation (2) Contraceptive methods for injection or implantation of hormones; (3) Establish Intrauterine device (IUD) or Intrauterine system (IUS); (4) Barrier contraceptive method: condom or plug cap (diaphragm or neck / cap); (5) Male partners who have undergone effective surgical sterilization; 5. Female subjects must agree not to breastfeed throughout the study period and 28 days after the withdrawal of the drug from screening; 6. Female participants are not allowed to donate eggs from screening and during the course of the study and within 28 days after the withdrawal of the research drug; 7. Male participants are not allowed to donate sperm during the course of the study and within 28 days after the withdrawal of the drug from screening; 8. Male subjects with a pregnant or lactating partner must agree to abstinence or the use of male condoms throughout the study period and 28 days after the withdrawal of the study drug during their partner's pregnancy or breastfeeding; 9. Male subjects agreed to use highly effective contraception, including, but not limited to, condom use throughout the study period and within 28 days after the withdrawal of the drug; 10. Participants agreed not to participate in another study in this study, defined as signing informed consent until the last study visit was completed; 11. part 1 and 2, uric acid = 268umol/l (4.5mg/dl), part 3, serum uric acid in men = 420 umolr / l, in women = 360 umol.
Exclusion criteria
Exclusion criteria: 1. Subjects were treated 28 days before screening (or 5 half-lives, whichever is older); 2. The researchers determined that the subjects were unfit to participate in the study; 3. Female subjects are pregnant or lactating; 4. Subjects had known or suspected allergic reactions to any component of the HP501 or preparation; 5. The subjects had a clinically significant history of allergies (including drug allergies, asthma, eczema, or allergic reactions), but not untreated, asymptomatic seasonal allergies; 6. According to the researchers, the subjects had any clinically significant cardiovascular, gastrointestinal, endocrine, blood, liver, immune, metabolic, urinary, lung, neurological, skin disease, psychosis, History or evidence of kidney and / or other major diseases or malignancies; 7. The subjects met any of the following criteria: (1) history of gout (with the exception of part 3); (2) history of secondary hyperuricemia and hyperparathyroidism; (3) has a history of xanthine urine, inflammatory bowel disease or enterectomy; (4) history of renal tubular acidosis; (5) there was a history of urinary calculi and / or abdominal ultrasonography during screening period found urinary calculi; 8. Subjects had / had fever, disease or symptoms, viruses, bacteria (including upper respiratory tract infections) or fungal (non-skin) infections within 2 days before administration; 9. During the screening period or two days before administration, the researchers determined that the subjects had clinically significant abnormalities, including physical examination, electrocardiogram (ECG) and safe laboratory tests as defined in the protocol; 10. The mean pulse 100 bpm; mean systolic blood pressure 140 mmHg; mean diastolic blood pressure 90 mmHg, if the average pulse or blood pressure exceeded the upper limit and the mean systolic blood pressure was still abnormal; 11. The average QTcF intervals were > 450ms (males) and > 470ms (females) during the screening period or 2 days before administration. If the average QTcF is above the upper limit and three copies of ECG are still abnormal; 12. Subjects had unexplained syncope, cardiac arrest, unexplained arrhythmia or torsion of the tip ventricular tachycardia, structural heart disease or long family history of QT syndrome; 13. Subjects were given any prescription or over-the-counter drugs (including vitamins, natural medicines and herbs such as St. John's wort) two weeks before administration; 14. During the six months before screening, the subjects smoked more than five cigarettes a day; 15. The subjects drank more than 21 units of alcohol (1 unit = 10 g pure alcohol = 250ml beer [5%] or 35ml spirits [35%] or 100ml wine [12%] per week within 2 days before administration) (female subjects > 14 units of alcohol). The subjects tested positive for alcohol 2 days before screening or administration; 16. The subjects had a history of drug abuse within 1 year before administration, or the screening period was positive for drug abuse (methamphetamine, methoxymethamphetamine, ketamine, morphine, heroin) within 2 days before administration; 17. The subjects consumed grapefruit / Seville oranges, grapefruit products or Seville orange products within 72 hours of admission; 18. Subjects were given any metabolic inducer (such as barbiturates, rifampicin, etc.) 3 months before administration and 2 days before administration; 19. The subjects had significant blood loss wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK;PD;safety; | — |
Countries
China
Contacts
Public ContactZheng Li; Gou Zhongping
West China Hospital, Sichuan University
Outcome results
None listed