A Phase I Study of LX22001 for Injection in Healthy Subjects
- Conditions
- Healthy
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria:<br><br> 1. Subjects who fully understand the objectives, nature, methods and possible AEs of<br> the study, voluntarily participate in the clinical study, and sign the Informed<br> Consent Form (ICF) before the initiation of any study procedure, and warrant that<br> any study procedure will be participated in by themselves;<br><br> 2. Healthy Chinese subjects aged 18-45 years (inclusive, at the date of signing the<br> ICF), both males and females;<br><br> 3. Body mass index (BMI): 19.0-26.0 kg/m2 (inclusive); weight: = 50 kg for male and =<br> 45 kg for female;<br><br> 4. Subjects who are willing to use effective contraception and have no sperm or egg<br> donation plan from the time of signing the informed consent form until 3 months<br> after the last dose (see Appendix 20.1 for details of contraceptive measures and<br> contraceptive requirements);<br><br> 5. Subjects who can communicate well with the investigator, and understand and comply<br> with the requirements of this study.<br><br>Exclusion Criteria:<br><br> 1. Allergy (such as: allergic to two or more drugs, foods, or pollen), history of<br> atopic allergic disease (such as: asthma, urticaria, eczematous dermatitis, etc.),<br> history of allergy to any of the components and excipients of the study drugs<br> (LX22001 for injection, tegoprazan tablets, and Esomeprazole Sodium for injection),<br> or allergy to penicillin, cephalosporin, and other antibiotics;<br><br> 2. Any disease or history of disease that may significantly affect drug absorption,<br> distribution, metabolism, and excretion, or any condition that may pose a hazard to<br> the subject, such as: inflammatory bowel disease, gastric ulcer, duodenal ulcer,<br> gastrointestinal/rectal bleeding, persistent nausea, or other clinically significant<br> gastrointestinal anomalies; history of major gastrointestinal surgery (such as:<br> gastrectomy, gastrointestinal anastomosis, bowel resection, gastric bypass, gastric<br> banding, cholecystectomy, except for appendicitis surgery and prolapse surgery);<br><br> 3. History of chronic or serious illness or present illness of cardiovascular, hepatic,<br> renal, respiratory, hematologic and lymphatic, endocrine, immunologic, psychiatric,<br> neurologic, gastrointestinal, metabolic, and skeletal systems within the last 1<br> year;<br><br> 4. Clinically significant abnormalities in physical examination and laboratory tests at<br> screening, judged by the investigators;<br><br> 5. For those with clinically significant abnormalities in vital signs at screening<br> which will be judged by the investigators based on the actual situations;<br><br> 6. The serological virology test shows positive results of HIV antigen antibody<br> (HIV-Ag/Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or<br> treponema pallidum antibody (TP-Ab) at screening;<br><br> 7. Women who have not taken effective contraception within 15 days prior to the<br> screening period, or have a positive blood pregnancy test or are breastfeeding<br> during the screening period;<br><br> 8. Those who have a history of drug abuse within the past five years or drug use in the<br> three months prior to screening, or positive results for urine drug test during the<br> screening period;<br><br> 9. Those who smoke more than 5 cigarettes per day or had a habit of using<br> nicotine-containing products within 3 months prior to screening, or test positive<br> for nicotine test at screening;<br><br> 10. Those who drink more than 14 units of alcohol per week (1 unit of alcohol = 360 mL<br> of beer or 45 mL of ABV 40% spirit or 150 mL of wine) within 3 months prior to<br> screening or have consumed an alcohol-containing product 48h prior to the dose or<br> test positive for alcohol breath test at screening;<br><br> 11. Those who have used any medication (including prescription, over-the-counter,<br> nutritional supplements, Chinese herbal medicine, vitamins, etc.) or are on<br> medication within 1 month prior to screening;<br><br> 12. Those who have participated in other clinical studies and used other investigational<br> drugs or interventional therapies within 3 months prior to screening;<br><br> 13. Those who have donated or lost more than 200 mL of blood or received blood<br> transfusion or used blood products within 3 months prior to screening;<br><br> 14. Those who have consumed any food or beverage containing caffeine or producing<br> caffeine or xanthine metabolites (e.g., coffee, tea, chocolate) within 48h prior to<br> the dose;<br><br> 15. Those who have consumed grapefruit, limes, carambola,pitaya, mango or food or drinks<br> prepared from them within 7 days prior to screening;<br><br> 16. Those who are unable to establish intravenous access or intolerable to intravenous<br> administration;<br><br> 17. Those who are involved in the planning and execution of this study;<br><br> 18. Any other circumstance that, in the opinion of the investigator, the subject may be<br> hindered from providing informed consent or following the protocol, or the subject's<br> participation in the study may affect the results of the study or his or her own<br> safety.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve From Time 0 to the 24-Hour Time Point (AUC0-24);Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf);Maximum Observed Plasma Concentration (Cmax);Terminal elimination half-life(t1/2);Apparent total body clearance (CL);Apparent volume of distribution(Vd);Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) at Steady State;Cmax at Steady State (Cmax,ss);Percentage of Time Gastric pH above 4 over 24h;Percentage of Time Gastric pH above 6 over 24h;Mean Gastric pH over 24h