Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on DA414

Last updated: July 23, 2024
Sponsor: Chendu DIAO Nine Hong Pharmaceutical Factory
Overall Status: Active - Recruiting

Phase

1

Condition

Blood Clots

Stroke

Thrombosis

Treatment

DA414 placebo

DA414 Granules

Clinical Study ID

NCT06525168
Chendu DIAO NineHong Factory
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  1. Subjects are fully aware of the purpose, nature, procedures, and possibleadverse effects of the trial, volunteer as subjects, and sign an informedconsent form prior to the start of any study procedures;

  2. Healthy subjects aged 18-45 years (including the threshold);

  3. Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index (BMI) in therange of 19.0-26.0 kg/m2 (including threshold values);

  4. 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 todonate sperm or eggs;

  5. Those who are able to communicate well with the researcher and understand andcomply with the requirements of this study.

Exclusion

  • Exclusion Criteria:
  1. Have a history of specific allergies (asthma, urticaria, eczema, etc.) orallergic constitution (such as known allergy to two or more substances), orknown history of allergy to DA414 and related excipients

  2. Those with an acute illness occurring within 2 weeks prior to screening;

  3. 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 oneyear prior to screening, or a history of gastrointestinal disorders (includingexisting) within one year prior to screening This includes chronic or activeupper gastrointestinal diseases such as esophageal disease, gastritis,duodenitis, peptic ulcers, or active gastrointestinal bleeding, orgastrointestinal surgery;

  4. Screening vital signs, physical examination, clinical laboratory tests (routineblood, urine, blood biochemistry, coagulation, blood transfusion), chest X-ray,abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidneys), andresults of clinically significant abnormality as judged by the investigator;

  5. Those whose ECG results showed QTc>440ms at screening (Fridericia's formulacorrection, calculated as QTcF= QT/(RR0.33));

  6. Those who have undergone major surgical procedures (excluding diagnosticsurgical procedures) within 6 months prior to screening, or who are scheduledto 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;

  7. Those who have used any medications (including any prescription drugs,over-the-counter drugs, herbal preparations and formulas, etc.) andnutraceuticals within 2 weeks prior to the first dose;

  8. Inhibitors or inducers of CYP3A4, CYP2B6 within 30 days prior to first dosee.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.

  9. Those who ingested strong tea, caffeine-containing, alcoholic beverages, orfoods that interfere with drug metabolism, such as popcorn, papaya, blackberry,grapefruit, or grapefruit products, within 48h prior to drug administration;

  10. Those who had received a live attenuated vaccination within 2 weeks prior toscreening or who required live attenuated vaccination during the trial;

  11. Participants who have participated in other clinical trials within 3 monthsprior to screening (Note: End time is defined as the date of exit from the lastclinical trial in which they participated);

  12. Those who have donated blood within 3 months prior to screening, those who havelost a total of 400 mL or more of blood from blood donation or other causeswithin 6 months (except for normal blood loss during physiological periods inwomen), or those who have had unexplained abnormal bleeding in the past;

  13. Persons who have consumed an average of more than 2 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol liquor or 150 mL of wine)during the past year, or who were unable to abstain from alcohol during thetest period, or who have had a breath test result of greater than 0.0 mg/100 mLof alcohol;

  14. Those who smoked more than 5 cigarettes per day in the 3 months prior toscreening or who were unable to stop using any tobacco products during thetrial.

  15. Those with a history of substance abuse (including repeated, heavy non-medicaluse of all types of narcotic drugs and psychotropic substances) or a positivesubstance abuse screen (including: morphine, methamphetamine (meth), ketamine,ecstasy (MDMA), marijuana (tetrahydrocannabinolic acid (THC)), etc.) within thepast year;

  16. Individuals who cannot tolerate venipuncture/indwelling needles,or who have ahistory of needle and blood sickness,or who have difficulty swallowing;

  17. lactose-intolerant

  18. Those who have special dietary requirements and cannot accept a uniform diet;

  19. Other subjects judged by the investigator to be unsuitable forparticipation.Female subjects shall be excluded if, in addition to the aboverequirements, they meet the following criteria:

  20. Those who used oral contraceptives within 30 days prior to screening;

  21. Use of long-acting estrogen or progestin injections (with progestin-based IUDs)or implants within 6 months prior to screening;

  22. Unprotected sex with partner within 14 days prior to screening

  23. A woman who has a positive pregnancy test or a test result that is not withinnormal values or within the range of non-pregnant status;

  24. Pregnant or lactating women;

Study Design

Total Participants: 82
Treatment Group(s): 2
Primary Treatment: DA414 placebo
Phase: 1
Study Start date:
February 06, 2024
Estimated Completion Date:
September 30, 2026

Study Description

Acute ischemic stroke is the most common type of stroke, characterized by high incidence, prevalence, recurrence, disability, and mortality rates, posing a serious threat to public health. However, the current treatment measures are limited and often ineffective. According to existing preclinical data, DA414 has demonstrated significant development potential in both in vitro and in vivo pharmacodynamic studies across multiple batches and models. Based on the data-driven insights, the sponsor will conduct single ascending dose (SAD) studies, multiple ascending dose (MAD) studies, and food effect studies of DA414 in healthy subjects.

Connect with a study center

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China

    Wuhan, Hubei.China 430000
    China

    Active - Recruiting

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