Phase
Condition
Reproductive Health
Treatment
[14C]SHR7280
Clinical Study ID
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Sign the informed consent form prior to the trial and have a full understanding ofthe trial's procedures, content, and potential adverse reactions;
Healthy adult females and males between 18 and 45 years;
Body weight ≥50 kg(for male), body weight ≥45 kg(for female), and the body massindex (BMI) of 19 to 26 kg/m2;
From the signing of the informed consent form until 12 months after the lastadministration, the subject (including partner) has no family planning and iswilling to use the high-efficiency contraceptive measures specified in the plan;
The first three menstrual cycles for women were regular, with a menstrual cycle of 21-35 days, and no abnormal uterine bleeding occurred.
Exclusion
Exclusion Criteria:
Comprehensive physical examination, vital signs, laboratory tests (blood routine,blood biochemistry, coagulation function, urine analysis, fecal routine+occultblood, thyroid function), full chest X-ray, 12 lead electrocardiogram, abdominalultrasound, digital rectal examination, bilateral breast, uterus, and bilateralaccessory ultrasound results that the researcher deems clinically significant;
Serum testosterone (T) <3.46 ng/mL during screening for male; serum folliclestimulating hormone (FSH) ≥ 25mIU/mL during screening period for female;
Patients with QTcF>450 msec (male) and QTcF>470 msec (female) at the time ofscreening or baseline, or other clinically significant abnormalities determined bythe researcher;
Hepatitis B surface antigen (HBsAg) positive, or anti hepatitis C virus (HCV)antibody positive, or human immunodeficiency virus (HIV) antigen/antibody combinedtest positive, or Treponema pallidum antibody positive;
Screening period or baseline period (D-1) serum pregnancy testing (serum β- The HCGtest )result is positive for female;
Women use the following contraceptive methods during screening visits:sustained-release intrauterine devices, sustained-release contraceptives (subcutaneous implants, vaginal rings, microspheres, and microcapsules); Beforescreening, use long-acting contraceptive pills (using medroxyprogesterone acetatefor 3 months and other injections for 1 month), oral contraceptives (such as shortacting, long-acting, or emergency contraceptives) for 2 months before screening, andcontraceptive patches for 1 month before screening; Special circumstances to bedetermined by the researcher;
Abuse of drugs or use of soft drugs (such as marijuana) in the three months prior toscreening, or use of hard drugs (such as amphetamines, phencyclidine, etc.) in theyear prior to screening; Or screening period urine drug test positive individuals,including: morphine, methamphetamine (methamphetamine), ketamine, ecstasy (methamphetamine), marijuana (tetrahydrocannabidiol acid);
Using any prescription, over-the-counter, herbal or dietary supplements before thefirst two screening weeks;
Women with a history of pregnancy, miscarriage, childbirth, or breastfeeding in the 6 months prior to screening;
Any clinical history of serious diseases or conditions that the researcher believesmay affect the trial results, including but not limited to a history of circulatory,endocrine, nervous, digestive, urinary, or blood, immune, mental, and metabolicdiseases;
Individuals with a history of malignant tumors or suspected to have sex hormonedependent malignant tumors;
Allergic constitution, or suspected allergy to any ingredient in SHR7280formulation;
Individuals who have undergone any surgery in the first 3 months prior to screening,have not yet recovered after surgery, or are expected to have surgery orhospitalization plans during the trial period;
Perianal diseases with hemorrhoids or periodic/ongoing rectal bleeding; The subjectis unable to swallow, or has a history of gastrointestinal dysfunction such asirritable bowel syndrome, inflammatory bowel disease, or has undergone surgery suchas gastrectomy, which the researcher determines may affect drug absorption;
Habitual constipation or diarrhea;
Have a history of severe vomiting;
Individuals with a history of smoking in the first three months prior to screening (average daily smoking>5 cigarettes);
In the three months before screening, the average daily intake of alcohol exceeded 25 g (for example, 750 mL of beer, 250 mL of wine, or 50 mL of Baijiu); Or thosewith an alcohol breath test result of ≥ 20 mg/dl during the screening period;
Habitually drinking grapefruit juice or excessive amounts of tea, coffee, and/orcaffeinated beverages, or unable to quit during the trial period;
Select clinical trial participants who have participated in any other drug ormedical device within the first 3 months or within 5 half-lives of the drug (depending on whether the drug is administered or the device is used);
Those who receive the vaccine within 2 weeks before the first administration orwithin 1 month after the last administration during the study period;
Individuals who have donated (or lost) blood and have donated (or lost) more than 400 mL of blood, or have received blood transfusions in the first 3 months prior toscreening;
Engaged in workers who require long-term exposure to radioactive conditions; Orselect individuals who have been significantly exposed to radiation (chest/abdominalCT ≥ 2 times, or other types of X-ray examinations ≥ 3 times) or have participatedin radiopharmaceutical labeling trials in the one year prior to screening;
Difficulty swallowing, difficulty in venous blood collection, or physical conditionunable to withstand blood collection; Or subjects who are expected to be unable tocomplete the entire trial follow-up;
According to the researcher's judgment, the subjects may have factors that affectdrug absorption, distribution, metabolism, and excretion, or may reduce compliance,or other factors that are not suitable for participation in this study.
Study Design
Connect with a study center
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu 215008
ChinaSite Not Available
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