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 range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Ischemic Stroke trials