Status:
COMPLETED
A Phase 1 Study to Evaluate PK Profile of Multiple Oral Administrations of TNP-2092 Capsules in Healthy Subjects
Lead Sponsor:
TenNor Therapeutics (Suzhou) Limited
Collaborating Sponsors:
The First Hospital of Jilin University
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study was a single-center, randomized, double-blind, placebo-controlled, dose-ascending multiple-dose-administration study. The aim of this study was to evaluate the safety, tolerability, and pha...
Detailed Description
This study was a single-center, randomized, double-blind, placebo-controlled, dose-ascending multiple-dose-administration study. The aim of this study was to evaluate the safety, tolerability, and pha...
Eligibility Criteria
Inclusion
- Those who are fully informed of and understand this study and have signed the Informed Consent Form.
- Those who are willing to follow and able to complete all the trial procedures.
- Female subjects of childbearing potential must agree to abstinence or take effective contraceptive measures during the trial and at least 70 days (10 weeks) after administration.
- Male subjects must agree to abstinence or use condoms as a contraceptive measure during the trial and at least 70 days (10 weeks) after administration.
- Sex: male or female.
- Age: 18-45 years, including 18 and 45 years.
- BMI: 19.0-26.0 kg/m2, including 19.0 and 26.0 kg/m2.
- Those who do not smoke, or have smoked less than 5 cigarettes per day within 3 months before screening; those who do not drink alcohol, or have drunk less than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) within 6 months before screening; those who have not smoked or drunk alcohol within 48 hours before admission to the study site.
- Subjects whose clinical laboratory test results are within the normal range or whose test results are abnormal but judged by the investigator to be of no clinical insignificance.
- Those with a positive 14C urea breath test (UBT) result.
Exclusion
- Those with an allergic constitution, a history of allergic diseases or a history of drug allergy.
- Those with a history of alcohol or drug abuse in the past 10 years.
- Those who have donated blood within 3 months before enrollment.
- Those with regular use of any prescription/over-the-counter drugs, including vitamins, minerals, nutritional supplements or herbs, within 2 weeks before enrollment and during the study period.
- Those who have taken any drug that changes the activity of liver enzymes 28 days before taking the investigational product or during the study.
- Those who have participated in any clinical trials within 3 months before enrollment.
- Those with a history of eradication of Helicobacter pylori.
- Those who are suffering or have suffered from digestive tract diseases, including digestive tract ulcer, etc.
- Those with symptoms or past medical history of cardiovascular, respiratory, urinary, neurological, blood, immune, endocrine system diseases or tumor, mental illness, or any situation which, in the opinion of the investigator, may threaten the safety of the subjects or affect the correctness of the trial results.
- Those whose blood pressure remains above 140/90 mmHg after retest.
- Pregnant or lactating women.
- Those who are HIV positive, syphilis positive, hepatitis B surface antigen positive, hepatitis C antibody positive.
- Those who have had beverages or foods containing methylxanthine (coffee, tea, coke, chocolate, and energy drinks), grapefruit (fruit juice) and alcohol within 48 hours (2 days) before the clinical study.
- Other circumstances deemed by the investigator to be unsuitable for the subject to participate in this study.
Key Trial Info
Start Date :
November 8 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06190340
Start Date
November 8 2016
End Date
September 26 2017
Last Update
February 27 2025
Active Locations (1)
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1
The First Hospital of Jilin University
Changchun, Jilin, China