Health TrialsbyHealthPanel

Pharmacokinetics of Huperzine A Oral Solution in Healthy Participants

ConditionHealhty
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorWanbangde Pharmaceutical Group Co., LTD

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • Huperzine A Oral Solution

    Drug

    Investigational huperzine A oral solution, administered orally in 4 sequential escalating multiple-dose cohorts to healthy adult participants.

  • Placebo

    Drug

    Matching placebo, identical in appearance, taste and packaging to huperzine A oral solution, administered orally for multiple doses.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Huperzine A Oral SolutionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From first study drug administration through Day 9

Secondary outcomes

1

Time to Peak Plasma Concentration (Tmax)

Time frame
Day 1 and Day 7
2

Peak Plasma Concentration (Cmax)

Time frame
Day 1 and Day 7
3

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t)

Time frame
Day 1 and Day 7
4

Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC0-∞)

Time frame
Day 1 and Day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wanbangde Pharmaceutical Group Co., LTD

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: