RecruitingPhase 1

Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on DA414

China82 participantsStarted 2024-02-06

Plain-language summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and Food Effects of DA414 Granules in Chinese healthy subjects with single and multiple doses.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. Subjects are fully aware of the purpose, nature, procedures, and possible adverse effects of the trial, volunteer as subjects, and sign an informed consent form prior to the start of any study procedures;
✓. Healthy subjects aged 18-45 years (including the threshold);
✓. Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including threshold values);
✓. Subjects are voluntarily using effective contraception during the trial and for 6 months after the last dose, and are not planning to have children or to donate sperm or eggs;
✓. Those who are able to communicate well with the researcher and understand and comply with the requirements of this study.

Exclusion criteria

✕. Have a history of specific allergies (asthma, urticaria, eczema, etc.) or allergic constitution (such as known allergy to two or more substances), or known history of allergy to DA414 and related excipients
✕. Those with an acute illness occurring within 2 weeks prior to screening;
✕. Persons with a history of chronic or serious disease of the cardiovascular, hepatic, renal, biliary, respiratory, hematologic and lymphatic, endocrine, immunologic, psychiatric, neuromuscular, or gastrointestinal systems within one year prior to screening, or a history of gastrointestinal disorders (including existing) within one year prior to screening This includes chronic or active upper gastrointestinal diseases such as esophageal disease, gastritis, duodenitis, peptic ulcers, or active gastrointestinal bleeding, or gastrointestinal surgery;
✕. Screening vital signs, physical examination, clinical laboratory tests (routine blood, urine, blood biochemistry, coagulation, blood transfusion), chest X-ray, abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidneys), and results of clinically significant abnormality as judged by the investigator;
✕. Those whose ECG results showed QTc\>440ms at screening (Fridericia's formula correction, calculated as QTcF= QT/(RR0.33));
✕. Those who have undergone major surgical procedures (excluding diagnostic surgical procedures) within 6 months prior to screening, or who are scheduled to undergo surgery during the study period, or who have undergone surgery that, in the judgment of the investigator, would interfere with drug absorption, distribution, metabolism, or excretion;
✕. Those who have used any medications (including any prescription drugs, over-the-counter drugs, herbal preparations and formulas, etc.) and nutraceuticals within 2 weeks prior to the first dose;
✕. Inhibitors or inducers of CYP3A4, CYP2B6 within 30 days prior to first dose e.g., inducers - rifampicin, phenobarbital, carbamazepine, phenytoin; inhibitors - clarithromycin, itraconazole, ketoconazole, ritonavir, azamorelin,zithromycin,verapamil,sertraline, phencyclidine, septiparatide, ticlopidine. azamorelin,zithromycin,verapamil,sertraline, phencyclidine, septiparatide, ticlopidine.

What they're measuring

safety and tolerability

Timeframe: Through study completion, an average of 28 days.

Trial details

NCT IDNCT06525168

SponsorChendu DIAO Nine Hong Pharmaceutical Factory

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-30

Contact for this trial

Guangxin Dong, Docter

13668161898 dongguangxin@diao.com

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