Single Ascending Dose Study(SAD),Multiple Ascending Dose Study(MAD) , High-fat Diet Study (FE) of… (NCT07394452) | Clinical Trial Compass
CompletedPhase 1
Single Ascending Dose Study(SAD),Multiple Ascending Dose Study(MAD) , High-fat Diet Study (FE) of TJ0113 Capsules in Healthy Subjects
China130 participantsStarted 2023-08-04
Plain-language summary
The study included three clinical studies, namely a single ascending dose (SAD) study, a multiple ascending dose (MAD) study, and a high-fat diet food effect (FE) study.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Voluntarily participate in the clinical trial, sign the informed consent form, understand and agree to follow the protocol, have a full understanding of trial contents, process, and possible adverse reactions, and indicate the date of signing;
✓. Aged 18 \~ 55 years (inclusive), Chinese healthy male or female;
✓. Body weight ≥ 50 kg (male) or ≥ 45 kg (female), body mass index (BMI) within the range of 19.0 \~ 26.0 kg/m2 (inclusive);
✓. Subjects and their partners have no plans for pregnancy, donation of sperm or eggs, and voluntarily take effective contraceptive measures (such as abstinence, condom, etc.) from the screening phase until 6 months after the end of the trial;
✓. Able to communicate well with the investigator, understand and agree to follow all requirements of this trial.
Exclusion criteria
✕. Subjects with a history or current presence of chronic diseases involving the cardiovascular, respiratory, urinary, nervous, psychiatric, hematological, endocrine and metabolic (diabetes, thyroid disease, adrenal disease), and immune systems, and deemed unsuitable for participation by the investigator.
✕. Subjects who have received surgery within 3 months before screening, or plan to receive surgery during the trial; or have received medical or surgical treatment (such as gastrointestinal surgery) permanently changing the absorption, distribution, metabolism and excretion of oral drugs (except for hernia repair); a history of abdominal surgery, such as cholecystectomy (except for uncomplicated appendectomy and endoscopic treatment of gastrointestinal polyps after 6 months);
✕. Subjects with dysphagia or gastrointestinal, liver, or kidney diseases (regardless of whether they have been cured) within 6 months before screening that could affect drug absorption or excretion;
What they're measuring
1
Treatment-emergent adverse event (TEAE) incidence of TJ0113 capsules after single oral administration in SAD study
Timeframe: Within 12 days after the last administration
2
Treatment-emergent adverse event (TEAE) incidence of TJ0113 capsules after multiple oral administration in MAD study
Timeframe: Within 12 days after the last administration
✕. History of clinically significant drug allergy or specific allergic diseases (such as asthma, urticaria) or known hypersensitivity to the investigational product or its excipients;
✕. Subjects who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or supplements within 14 days before the first dose;
✕. Subjects with abnormal and clinically significant results on physical examination, vital signs, laboratory tests (blood routine test, urinalysis + specific gravity, blood biochemistry, coagulation function, etc.) at screening and baseline;
✕. Subjects with clinically significant 12-lead ECG abnormalities at screening or baseline, or with an average QTcF (corrected QT interval using Fridericia's formula) \>450 ms for males, \>470 ms for females, QRS \>120 ms, or a history of long QT syndrome.
✕. Subjects who have special dietary requirements and cannot abide by the standard diet;