The Study of Pharmacokinetics and Pharmacodynamics of Huperzine a Injection in Healthy Chinese Subjects

NCT06570655 | Completed Phase 1

• 1 other identifier: 2024040905
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study used a single-center, open, sequential single-dose design. To evaluate the pharmacokinetics and dose-exposure relationship of huperzine A injection

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Maximum blood concentration of Huperzine A(Cmax)

  To measure the Cmax of Huperzine A in 4 different periods of sequential administration in 12 healthy subjects.

  Day1、Day8、Day15、Day22

• PK: Area under the Huperzine A blood concentration-time curve from 0min to the time of last concentration(AUC0-t)

  To measure the AUC0-t of Huperzine A in 4 different periods of sequential administration in 12 healthy subjects.

  Day1、Day8、Day15、Day22

• PK：Area under the Huperzine A blood concentration-time curve from 0min to the infinity time (AUC0-∞)

  To measure the AUC0-∞ of Huperzine A in 4 different periods of sequential administration in 12 healthy subjects.

  Day1、Day8、Day15、Day22

Secondary Outcomes (18)

• PD: maximum efficacy(Emax)

  Day1、Day8、Day15、Day22

• PD: Area under the efficacy curve(AUEC)

  Day1、Day8、Day15、Day22

• PD: Time to reach maximum efficacy(Tmax)

  Day1、Day8、Day15、Day22

• PK: Time to peak maximum concentration of the Huperzine A(Tmax)

  Day1、Day8、Day15、Day22

• PK: half life of Huperzine A(t1/2)

  Day1、Day8、Day15、Day22

Study Arms (1)

experimental group

EXPERIMENTAL

The same 12 subjects first received 0.2 mg single dose intravenously, then received intramuscular injection of single-dose 0.1 mg, followed by single-dose 0.2 mg, and finally single-dose 0.4 mg. A wash-out period of 7 days was applied between the doses.

Drug: Huperzine A injection

Interventions

Huperzine A injection DRUG

intramuscular

experimental group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• The subjects were able to communicate well with the investigators and complete the trial in accordance with the protocol;
• Gender: Chinese male or female;
• Age: 18-45 years old (including boundary value);
• 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.

You may not qualify if:

• Allergic history to huperzine A or any of its components; Patients with a history of allergy to two or more drugs or foods;
• 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;
• existing or suspected existing epilepsy, angina pectoris, bronchial asthma, mechanical intestinal obstruction, renal insufficiency, urinary obstruction;
• underwent major surgical procedures within 6 months before screening or planned to undergo surgical procedures during the trial;
• if the vital signs, physical examination, electrocardiogram and laboratory findings are clinically significant;
• 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;
• 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;
• 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);
• 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;
• vaccinated within 1 month before screening or during the planned trial period and within 1 month after the end of the trial;
• participants who participated in a clinical trial and took a drug within 3 months before screening;
• 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;
• 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;
• 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;

Sponsors & Collaborators

• Wanbangde Pharmaceutical Group Co., LTD: lead
• Zhejiang Hospital: collaborator

Study Sites (1)

Clinical trial institution of the Zhejiang Xiaoshan hospital

Hangzhou, China/Zhejiang, 310000, China

Location

MeSH Terms

Interventions

huperzine A

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: August 26, 2024
• Study Start: May 16, 2024
• Primary Completion: June 20, 2024
• Study Completion: August 29, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)