HealhtyPhase 1NCT07784335
Pharmacokinetics of Huperzine A Oral Solution in Healthy Participants
A Phase 1 study testing Huperzine A Oral Solution in people with Healhty, run by Wanbangde Pharmaceutical Group Co., LTD at 1 site in China.
Trial summary
In this study, 4 dose groups are planned: Group 1 (0.22 mg, QD), Group 2 (0.22 mg, BID), Group 3 (0.44 mg, QD), and Group 4 (0.44 mg, BID). Ten healthy study participants will be enrolled in each dose group, and randomized to the investigational drug group or the placebo group in a 4:1 ratio (i.e., 8 study… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healhty
- What is being tested?
- Huperzine A Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must provide written informed consent prior to the study, with full understanding of the study's objectives, procedures, and potential adverse reactions;
- Participants must be able to communicate effectively with the investigators and comply with the protocol requirements throughout the study.
- Healthy male or female, aged 18 to 55 years (inclusive);
- Body mass index (BMI) range: 19.0 to 26.0 kg/m2 [BMI = body weight/height2 (kg/m2)] (inclusive); male weight ≥50 kg, female weight ≥45 kg.
Who cannot join
- History of allergy to huperzine A or any drug component (pharmaceutical-grade sodium benzoate); history of allergies to two or more drugs, foods, etc.;
- History or suspected history of gastrointestinal bleeding, or conditions posing a risk of gastrointestinal bleeding (e.g., peptic ulcer, inflammatory bowel disease, diverticula, hemorrhoids, colonic polyps, etc.);
- Currently diagnosed with or suspected of having epilepsy, angina pectoris, bronchial asthma, mechanical intestinal obstruction, renal insufficiency, or urinary tract obstruction;
- Currently diagnosed with or suspected of having other serious diseases that, in the judgment of the investigator, make the individual unsuitable for participation in the study. These may include, but are not limited to, diseases related to the respiratory, circulatory, digestive, hematologic, endocrine, immune, integumentary, neuropsychiatric, or otorhinolaryngologic systems;
- Underwent major surgery within 180 days prior to the first dose or plans to undergo surgery during the study period;
- Participants with significant abnormalities in vital signs (normal reference ranges for vital signs (including critical values): body temperature (aural) 35.9 ℃ to 37.4 ℃, sitting systolic blood pressure 90 mmHg to 140 mmHg, sitting diastolic blood pressure 60 mmHg to 90 mmHg, sitting pulse 50 to 100 beats per minute, respiratory rate 12 to 20 breaths per minute), physical examination, electrocardiogram (QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms (males) or >460 ms (females)), or laboratory test results, and judged by the investigator as unsuitable for participation in this study;
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- History of hepatitis B, hepatitis C, HIV, or syphilis and/or those with one or more abnormal results in infectious disease screening (anti-HIV antibody, hepatitis B surface antigen, anti-hepatitis C virus antibody, anti-Treponema pallidum antibody) that are considered clinically significant by the investigator;
- Study participants who have experienced blood loss (excluding normal physiological blood loss in females) or donated ≥200 mL of blood or donated blood components (e.g., plasma, platelets, peripheral blood stem cells, etc.) within 90 days prior to the first dose;
- Individuals who used any drugs that alter hepatic enzyme activity within 30 days prior to the first dose (e.g., inducers such as barbiturates, carbamazepine, phenytoin sodium, dexamethasone; inhibitors such as selective serotonin reuptake inhibitors [SSRIs], ciprofloxacin, diltiazem, macrolides, metronidazole, ketoconazole, verapamil, fluoroquinolones, etc.), or non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen, naproxen, etc.);
- Use of any medications (including prescription drugs, over-the-counter drugs, and herbal medicines) and health supplements within 14 days prior to the first dose or within 5 half-lives of previous medication (whichever is longer), with the exception of topical medications and ophthalmic drops intended for local use.
- Study participants who have been vaccinated within 30 days prior to the first dose or plan to be vaccinated within 30 days after the end of the study;
- Participation in any clinical study within 90 days prior to the first dose;
- History of drug abuse within 5 years prior to screening, and/or use of illicit drugs within 90 days prior to screening, and/or history of drug dependence, including herbal medicine, or positive urine drug screening;
- Average daily smoking of more than 5 cigarettes within 90 days prior to screening, or unwillingness to avoid using any tobacco products within 48 h prior to the first dose and during hospitalization, or positive result in nicotine screening;
- Regular alcohol consumption within 180 days prior to screening, defined as consuming more than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits or 150 mL of wine), or unwillingness to stop alcohol intake within 48 h prior to the first dose and during hospitalization, or positive result in alcohol breath test;
- Excessive daily consumption of tea, coffee, and/or caffeine-containing beverages (more than 8 cups, 1 cup = 250 mL) within 90 days prior to screening, or unwillingness to abstain from tea, coffee, and/or caffeine-containing foods, grapefruit (pomelo) and/or grapefruit juice (pomelo juice), and/or poppy-containing products within 48 h prior to the first dose and during hospitalization;
- Individuals who have plans for reproduction (including sperm or egg donation) from the time of signing the informed consent until 90 days after the last administration of the investigational product, and/or who do not agree to use effective non-pharmacological contraceptive methods during the study period;
- Individuals unable to adhere to a standardized diet during the study or those with lactose intolerance (e.g., experiencing diarrhea after consuming milk);
- Individuals with difficulty in venous blood collection (intolerance to venipuncture, history of needle or blood phobia, poor vascular condition, etc.);
- Individuals who are otherwise unable to complete the study or are deemed unsuitable for inclusion by the investigator shall also be excluded.
- In addition to the aforementioned criteria, female participants meeting any of the following conditions shall also be excluded:
- Currently pregnant or breastfeeding, or have a positive pregnancy test result;
- Use of oral contraceptives within 30 days prior to the first dose;
- Use of long-acting estrogen and/or progestin injections and/or implants within 180 days prior to the first dose;
- Unprotected sexual intercourse with a partner within 14 days prior to the first dose.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Ting Li, +86 13587876896, ywlcsy409@163.com
About this study
Official title: A Single-Center, Randomized, Double-Blind, Multiple-Dose, Dose-Escalation Study to Evaluate the Pharmacokinetics of Huperzine A Oral Solution in Healthy Participants
In this study, 4 dose groups are planned: Group 1 (0.22 mg, QD), Group 2 (0.22 mg, BID), Group 3 (0.44 mg, QD), and Group 4 (0.44 mg, BID). Ten healthy study participants will be enrolled in each dose group, and randomized to the investigational drug group or the placebo group in a 4:1 ratio (i.e., 8 study participants in the investigational drug group and 2 study participants in the placebo group). An appropriate gender ratio will be ensured within each dose group.
- Conditions
- Healhty
- Being tested
- Huperzine A Oral Solution, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huperzine A Oral SolutionDrug
Investigational huperzine A oral solution, administered orally in 4 sequential escalating multiple-dose cohorts to healthy adult participants.
PlaceboDrug
Matching placebo, identical in appearance, taste and packaging to huperzine A oral solution, administered orally for multiple doses.
| Study group | Role | What they receive |
|---|---|---|
| Huperzine A Oral Solution | Experimental | Healthy participants receive multiple escalating oral doses of huperzine A oral solution in sequential cohorts. Advancement to subsequent dose cohorts is gated by review from the Safety Monitoring Committee (SMC) and Sponsor. Subjects within each cohort are randomized to study drug or placebo. Receives: Drug: Huperzine A Oral Solution |
| Placebo | Placebo comparator | Healthy participants receive matching placebo oral solution for multiple-dose administration. Randomization to placebo occurs within each sequential dose cohort, following SMC-gated cohort progression rules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Assessments
Assess safety and tolerability by evaluating treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant abnormal findings from vital signs, physical examinations, 12-lead ECG (QTcF, PR interval, QRS duration, RR interval), and clinical laboratory tests.
Measured: From first study drug administration through Day 9
Secondary outcomes (18)
Time to Peak Plasma Concentration (Tmax)
Measured: Day 1 and Day 7
Peak Plasma Concentration (Cmax)
Measured: Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t)
Measured: Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC0-∞)
Measured: Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve Over One Dosing Interval (AUC0-τ)
Measured: Day 1 and Day 7
Percentage of Area Under the Curve Extrapolated to Infinite Time (AUC_%Extrap)
Measured: Day 1 and Day 7
Apparent Volume of Distribution Based on Terminal Phase (Vz/F)
Measured: Day 1 and Day 7
Apparent Total Clearance Based on Terminal Phase (CLz/F)
Measured: Day 1 and Day 7
Terminal Elimination Rate Constant (λz)
Measured: Day 1 and Day 7
Terminal Elimination Half-Life (t1/2)
Measured: Day 1 and Day 7
Mean Residence Time From Time Zero to Last Quantifiable Concentration (MRT0-t)
Measured: Day 1 and Day 7
Mean Residence Time From Time Zero Extrapolated to Infinite Time (MRT0-∞)
Measured: Day 1 and Day 7
Steady-State Trough Plasma Concentration (Cmin,ss)
Measured: Day 7
Steady-State Average Plasma Concentration Over One Dosing Interval (Cav,ss)
Measured: Day 7
Steady-State Peak-to-Trough Swing Factor (Swing)
Measured: Day 7
Steady-State Peak-to-Trough Degree of Fluctuation (DF)
Measured: Day 7
Accumulation Ratio Based on Peak Plasma Concentration (Rcmax)
Measured: Day 1 and Day 7
Accumulation Ratio Based on Area Under Curve Over One Dosing Interval (RAUC)
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start25 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealhtyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wanbangde Pharmaceutical Group Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784335
- Sponsor's protocol ID
- WP107-101
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Multiple-Dose, Dose-Escalation Study to Evaluate the Pharmacokinetics of Huperzine A Oral Solution in Healthy Participants
- ClinicalTrials.gov ID
- NCT07784335
- Acronym / sponsor ID
- WP107-101
- Conditions
- Healhty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wanbangde Pharmaceutical Group Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Aug 2026 (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.
In this study, 4 dose groups are planned: Group 1 (0.22 mg, QD), Group 2 (0.22 mg, BID), Group 3 (0.44 mg, QD), and Group 4 (0.44 mg, BID). Ten healthy study participants will be enrolled in each dose group, and randomized to the investigational drug group or the placebo group in a 4:1 ratio (i.e., 8 study participants in the investigational drug group and 2 study participants in the placebo group). An appropriate gender ratio will be ensured within each dose group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huperzine A Oral Solution | Experimental | Drug: Huperzine A Oral SolutionHealthy participants receive multiple escalating oral doses of huperzine A oral solution in sequential cohorts. Advancement to subsequent dose cohorts is gated by review from the Safety Monitoring Committee (SMC) and Sponsor. Subjects within each cohort are randomized to study drug or placebo. |
| Placebo | Placebo comparator | Drug: PlaceboHealthy participants receive matching placebo oral solution for multiple-dose administration. Randomization to placebo occurs within each sequential dose cohort, following SMC-gated cohort progression rules. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must provide written informed consent prior to the study, with full understanding of the study's objectives, procedures, and potential adverse reactions;
- Participants must be able to communicate effectively with the investigators and comply with the protocol requirements throughout the study.
- Healthy male or female, aged 18 to 55 years (inclusive);
- Body mass index (BMI) range: 19.0 to 26.0 kg/m2 [BMI = body weight/height2 (kg/m2)] (inclusive); male weight ≥50 kg, female weight ≥45 kg.
Key exclusion criteria (25 listed)
- History of allergy to huperzine A or any drug component (pharmaceutical-grade sodium benzoate); history of allergies to two or more drugs, foods, etc.;
- History or suspected history of gastrointestinal bleeding, or conditions posing a risk of gastrointestinal bleeding (e.g., peptic ulcer, inflammatory bowel disease, diverticula, hemorrhoids, colonic polyps, etc.);
- Currently diagnosed with or suspected of having epilepsy, angina pectoris, bronchial asthma, mechanical intestinal obstruction, renal insufficiency, or urinary tract obstruction;
- Currently diagnosed with or suspected of having other serious diseases that, in the judgment of the investigator, make the individual unsuitable for participation in the study. These may include, but are not limited to, diseases related to the respiratory, circulatory, digestive, hematologic, endocrine, immune, integumentary, neuropsychiatric, or otorhinolaryngologic systems;
- Underwent major surgery within 180 days prior to the first dose or plans to undergo surgery during the study period;
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 |
|---|---|---|
| Huperzine A Oral SolutionInvestigational huperzine A oral solution, administered orally in 4 sequential escalating multiple-dose cohorts to healthy adult participants. | Drug | Huperzine A Oral Solution |
| PlaceboMatching placebo, identical in appearance, taste and packaging to huperzine A oral solution, administered orally for multiple doses. | Drug | Placebo |
Primary outcome
Safety and Tolerability Assessments
Time frame: From first study drug administration through Day 9
Assess safety and tolerability by evaluating treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant abnormal findings from vital signs, physical examinations, 12-lead ECG (QTcF, PR interval, QRS duration, RR interval), and clinical laboratory tests.
18 secondary outcomes
Time to Peak Plasma Concentration (Tmax)
Time frame: Day 1 and Day 7
Peak Plasma Concentration (Cmax)
Time frame: Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t)
Time frame: Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC0-∞)
Time frame: Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve Over One Dosing Interval (AUC0-τ)
Time frame: Day 1 and Day 7
Percentage of Area Under the Curve Extrapolated to Infinite Time (AUC_%Extrap)
Time frame: Day 1 and Day 7
Apparent Volume of Distribution Based on Terminal Phase (Vz/F)
Time frame: Day 1 and Day 7
Apparent Total Clearance Based on Terminal Phase (CLz/F)
Time frame: Day 1 and Day 7
Terminal Elimination Rate Constant (λz)
Time frame: Day 1 and Day 7
Terminal Elimination Half-Life (t1/2)
Time frame: Day 1 and Day 7
Mean Residence Time From Time Zero to Last Quantifiable Concentration (MRT0-t)
Time frame: Day 1 and Day 7
Mean Residence Time From Time Zero Extrapolated to Infinite Time (MRT0-∞)
Time frame: Day 1 and Day 7
Steady-State Trough Plasma Concentration (Cmin,ss)
Time frame: Day 7
Steady-State Average Plasma Concentration Over One Dosing Interval (Cav,ss)
Time frame: Day 7
Steady-State Peak-to-Trough Swing Factor (Swing)
Time frame: Day 7
Steady-State Peak-to-Trough Degree of Fluctuation (DF)
Time frame: Day 7
Accumulation Ratio Based on Peak Plasma Concentration (Rcmax)
Time frame: Day 1 and Day 7
Accumulation Ratio Based on Area Under Curve Over One Dosing Interval (RAUC)
Time frame: Day 1 and Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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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.
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 Huperzine A Oral Solution in people with Healhty, run by Wanbangde Pharmaceutical Group Co., LTD 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 4 inclusion and 25 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: opening soon, as of the sponsor's last update on 25 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Li (+8613735826039, lijuan@wepon.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability Assessments (time frame: From first study drug administration through Day 9). 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 25 Aug 2026.