Ischemic StrokePhase 1DA414NCT06525168
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on DA414
A Phase 1 study testing DA414 Granules in people with Ischemic Stroke, run by Chendu DIAO Nine Hong Pharmaceutical Factory at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- DA414 Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2024to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Individuals who cannot tolerate venipuncture/indwelling needles,or who have a history of needle and blood sickness,or who have difficulty swallowing;
- lactose-intolerant
- Those who have special dietary requirements and cannot accept a uniform diet;
- Other subjects judged by the investigator to be unsuitable for participation.Female subjects shall be excluded if, in addition to the above requirements, they meet the following criteria:
- Those who used oral contraceptives within 30 days prior to screening;
- Use of long-acting estrogen or progestin injections (with progestin-based IUDs) or implants within 6 months prior to screening;
- Unprotected sex with partner within 14 days prior to screening
- A woman who has a positive pregnancy test or a test result that is not within normal values or within the range of non-pregnant status;
- Pregnant or lactating women;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Wuhan, Hubei.China, 430000
Yongning Lv, Docter, 13971596529, luyn_union@163.com
About this study
Official title: Phase I Clinical Study of the Safety, Tolerability, Food Effect and Pharmacokinetics of DA414 Granules After Single and Multiple Administration in Healthy Subjects
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.
Read the detailed 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.
- Conditions
- Ischemic Stroke
- Being tested
- DA414 Granules, DA414 placebo
- Keywords
- Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA414 GranulesDrug
Also called DA414
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.
DA414 placeboDrug
Also called Placebo
DA414 placebo single ascending doses. DA414 placebowill be orally administrated at single ascending doses of 25mg, 50 mg, 100mg and 200 mg.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: DA414 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0.
Measured: Through study completion, an average of 28 days.
Secondary outcomes (7)
Cmax
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: 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
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: 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
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: 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
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: 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
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.
Vz/F
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: 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-∞
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start6 Feb 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chendu DIAO Nine Hong Pharmaceutical Factory
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525168
- Sponsor's protocol ID
- Chendu DIAO NineHong Factory
- Acronym
- DA414
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of the Safety, Tolerability, Food Effect and Pharmacokinetics of DA414 Granules After Single and Multiple Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06525168
- Acronym / sponsor ID
- DA414 / Chendu DIAO NineHong Factory
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Chendu DIAO Nine Hong Pharmaceutical FactoryIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA414 Granules | Experimental | Drug: DA414 GranulesThe 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). |
| DA414 Placebo | Placebo comparator | Drug: DA414 placeboThe 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (24 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA414 GranulesAlso: DA414DA414 Granules single ascending doses. DA414 will be orally administrated at single ascending doses of 12.5 mg, 25mg, 50 mg, 100mg and 200 mg. | Drug | DA414 Granules |
| DA414 placeboAlso: PlaceboDA414 placebo single ascending doses. DA414 placebowill be orally administrated at single ascending doses of 25mg, 50 mg, 100mg and 200 mg. | Drug | DA414 Placebo |
Primary outcome
safety and tolerability
Time frame: Through study completion, an average of 28 days.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0.
7 secondary outcomes
Cmax
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.
Vz/F
Time frame: 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-∞
Time frame: Measured on 1 hour before administration and 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 72, 96, 144, 192 hours after administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DA414 Granules in people with Ischemic Stroke, run by Chendu DIAO Nine Hong Pharmaceutical Factory at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangxin Dong, Docter (13668161898, dongguangxin@diao.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability (time frame: Through study completion, an average of 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.