Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on DA414

NCT06525168 | Recruiting Phase 1

• 1 other identifier: Chendu DIAO NineHong Factory
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• safety and tolerability

  Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0.

  Through study completion, an average of 28 days.

Secondary Outcomes (7)

• Cmax

  Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.

• AUC0-t

  Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.

• Tmax

  Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.

• T1/2

  Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.

• CL/F

  Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.

Study Arms (2)

DA414 Granules

EXPERIMENTAL

The trial plans to conduct studies with five dosage groups. The 12.5 mg dosage group will include 2 subjects, both receiving DA414 granules. The 25 mg, 50 mg, and 100 mg dosage groups will each include 10 subjects randomly assigned in a 8:2 ratio (8 receiving the investigational drug and 2 receiving placebo). The 200 mg dosage group will include 8 subjects, randomly assigned in a 6:2 ratio (6 receiving the investigational drug and 2 receiving placebo).

Drug: DA414 Granules

DA414 Placebo

PLACEBO COMPARATOR

The trial plans to conduct studies with five dosage groups. The 12.5 mg dosage group will include 2 subjects, both receiving DA414 granules. The 25 mg, 50 mg, and 100 mg dosage groups will each include 10 subjects randomly assigned in a 8:2 ratio (8 receiving the investigational drug and 2 receiving placebo). The 200 mg dosage group will include 8 subjects, randomly assigned in a 6:2 ratio (6 receiving the investigational drug and 2 receiving placebo).

Drug: DA414 placebo

Interventions

DA414 Granules DRUG

DA414 Granules single ascending doses. DA414 will be orally administrated at single ascending doses of 12.5 mg, 25mg, 50 mg, 100mg and 200 mg.

Also known as: DA414

DA414 Granules

DA414 placebo DRUG

DA414 placebo single ascending doses. DA414 placebowill be orally administrated at single ascending doses of 25mg, 50 mg, 100mg and 200 mg.

Also known as: Placebo

DA414 Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Those who ingested strong tea, caffeine-containing, alcoholic beverages, or foods that interfere with drug metabolism, such as popcorn, papaya, blackberry, grapefruit, or grapefruit products, within 48h prior to drug administration;
• Those who had received a live attenuated vaccination within 2 weeks prior to screening or who required live attenuated vaccination during the trial;
• Participants who have participated in other clinical trials within 3 months prior to screening (Note: End time is defined as the date of exit from the last clinical trial in which they participated);
• Those who have donated blood within 3 months prior to screening, those who have lost a total of 400 mL or more of blood from blood donation or other causes within 6 months (except for normal blood loss during physiological periods in women), or those who have had unexplained abnormal bleeding in the past;
• 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 the test period, or who have had a breath test result of greater than 0.0 mg/100 mL of alcohol;
• Those who smoked more than 5 cigarettes per day in the 3 months prior to screening or who were unable to stop using any tobacco products during the trial.
• Those with a history of substance abuse (including repeated, heavy non-medical use of all types of narcotic drugs and psychotropic substances) or a positive substance abuse screen (including: morphine, methamphetamine (meth), ketamine, ecstasy (MDMA), marijuana (tetrahydrocannabinolic acid (THC)), etc.) within the past year;

Sponsors & Collaborators

• Chendu DIAO Nine Hong Pharmaceutical Factory: lead

Study Sites (1)

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

Wuhan, Hubei.China, 430000, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Guangxin Dong, Docter

CONTACT

13668161898; dongguangxin@diao.com

Xiaolong Qin, PM

CONTACT

18781997925; luyn_union@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 29, 2024
• Study Start: February 6, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

CN (1)