Can a single injection of huperzine a unlock new treatments?
NCT ID NCT06570655
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This early-stage trial is testing how a single injection of huperzine A moves through the body and affects a key enzyme in red blood cells. Twelve healthy Chinese volunteers will receive the drug in four different ways to measure its concentration over time and its effect on acetylcholinesterase activity. The goal is to understand the drug's behavior and dosing, which could inform future studies for conditions like Alzheimer's disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Huperzine A injection
- What this could lead to
- If successful, this could help determine the right dosing for huperzine A, potentially supporting its development as a treatment for conditions like Alzheimer's disease.
- What could go wrong
- This is an early-phase study in a small group of healthy volunteers, so results may not predict effects in patients. The drug may also cause side effects, and the study is not designed to test effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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12 people
The number who actually took part.
- Started
-
May 2024
- Finished
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Aug 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The subject voluntarily confirms his or her willingness to participate in a particular trial and signed the written informed consent, after having been informed of all aspects of the trial that are relevant to the subject\'s decision to participate.They were fully aware of the adverse reactions and voluntarily signed the written informed consent. 2. The subjects were able to communicate well with the investigators and complete the trial in accordance with the protocol; 3. Gender: Chinese male or female; 4. Age: 18-45 years old (including boundary value); 5. Body mass index (BMI) 19.0-26.0 kg/m2 \[BMI = weight/height 2 (kg/m2)\] (including boundary values), body weight ≥50kg for men and ≥45kg for women. Exclusion Criteria: 1. Allergic history to huperzine A or any of its components; Patients with a history of allergy to two or more drugs or foods; 2. patients who have the following clinically significant diseases at present, including but not limited to diseases of the respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, mental nervous system, ENT and other related diseases; 3. existing or suspected existing epilepsy, angina pectoris, bronchial asthma, mechanical intestinal obstruction, renal insufficiency, urinary obstruction; 4. underwent major surgical procedures within 6 months before screening or planned to undergo surgical procedures during the trial; 5. if the vital signs, physical examination, electrocardiogram and laboratory findings are clinically significant; 6. patients with a history of hepatitis B, hepatitis C, AIDS, syphilis and/or clinically significant abnormalities in one or more of the four hemodialysis tests; 7. those who had lost blood within 3 months before screening (except physiological blood loss in women) or donated blood ≥200mL or donated blood components (such as plasma, platelets, peripheral blood stem cells, etc.) within 3 months; 8. use of any drugs that alter liver enzyme activity within 30 days before screening (e.g., inductors-barbiturates, carbamazepine, phenytoin, dexamethasone, etc.; \"Inhibitors - SSRI antidepressants, ciprofloxacin, diltiazem, macrolides, metronidazole, ketoconazole, verapamil. Rice, fluoroquinolones); 9. patients who had used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicine) and health products within 14 days before screening, except topical drugs and eye drops; 10. vaccinated within 1 month before screening or during the planned trial period and within 1 month after the end of the trial; 11. participants who participated in a clinical trial and took a drug within 3 months before screening; 12. had a history of drug abuse within 5 years, and/or used drugs within 3 months before screening, and/or had a history of drug dependence, including herbal medicine, or screened positive for drug abuse; 13. smokers or those who did not agree to avoid using any tobacco products 48 hours before administration and during hospitalization, or who screened positive for nicotine at the first admission; 14. Regular drinkers in the preceding 6 months, defined as consuming more than 14 units of alcohol per week (1 unit =360mL of 5% beer or 45mL of 40% spirits or 150mL of 12% wine), Or did not agree to stop alcohol intake 48 hours before administration and during hospitalization, or had a positive breath alcohol test at first admission; 15. subjects who consumed excessive amounts of tea, coffee and/or caffeinated beverages (\> 8 cups, 1 cup =250mL) per day before screening or disagreed with the prohibition of tea, coffee and/or caffeinated beverages 48 hours before drug administration and during hospitalization Or caffeinated foods, grapefruit (grapefruit) and/or grapefruit juice (grapefruit juice), and/or products containing poppy; 16. have a fertility plan (including sperm and egg donation plans) and/or do not agree to use an effective contraceptive method (non-drug during the trial) from the time of signing the informed consent until 3 months after the last dose of medication. Of; 17. difficulty in venous blood collection (unable to tolerate venipuncture, with a history of dizzy with needles and blood, poor vascular conditions, etc.); 18. subjects may not be able to complete the study for other reasons or should not be included according to the investigator\'s opinion. In addition to the above requirements, female subjects who meet the following conditions should also be excluded: 19. pregnant or lactating women or those with a positive pregnancy test; 20. who used oral contraceptives within 30 days before screening; 21. using long-acting estrogen and/or progestin injections and/or implants within 6 months before screening; 22. had unprotected sex with a partner within 14 days before screening.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinical trial institution of the Zhejiang Xiaoshan hospital
Hangzhou, China/Zhejiang, 310000, China
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