A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose and Multiple-dose X842 in Healthy Subjects.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Vital signs of blood pressure
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of X842 after administration of single and multiple doses in healthy subjects
Detailed Description
This is a single-center, open label, First-In-human (FIH), Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of single dose and multiple doses of X842 capsules in healthy subjects.
The study comprises a Single Ascending Dose (SAD) part, a Multiple Ascending Dose (MAD) part, and a Food Effect (FE) study.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Those aged 18-45 years old (inclusive the upper and lower limits).
- •Body weight of ≥ 50kg for male and ≥ 45kg for female , with a body mass index (BMI) of 19.0-26.0 kg/m2 (inclusive the upper and lower limits, BMI = weight (kg) / height (m) 2).
- •Understand and able to give written informed consent form for participation in this study voluntarily.
- •Those who fail to meet any of the above conditions shall not be enrolled.
Exclusion Criteria
- •Those who meet any of the following conditions shall not be enrolled:
- •History of any clinically significant disease or disorder in cardiovascular system, respiratory system, digestive system, endocrine system, nervous/mental system, blood and lymphatic system, and musculoskeletal system according to the investigator.
- •Comprehensive physical examination, vital signs, laboratory test, 12-lead ECG, or chest X-ray examination (anteroposterior and lateral view) suggests that there are abnormalities that are determined by the investigator to be clinically significant.
- •Those who received helicobacter pylori eradication therapy within 6 months prior to the study drug administration;
- •The results of helicobacter pylori screening (C-14 urea breath test) is positive;
- •Any positive result for hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV), or Treponema pallidum antibody (TP-Ab).
- •History of any food or drug allergy, or any other history of allergic disease (such as asthma, urticaria, and eczematous dermatitis, etc.) considered as clinical significant by the investigator.
- •Subjects who had taken any drug within 2 weeks prior to screening, which may affect the results of the study according to the investigator.
- •History of drug abuse within 12 months prior to screening or positive urine drug result at screening.
- •Those who regularly drink alcohol within 6 months prior to screening, that is, more than 14 units of alcohol weekly (1 unit = 360 mL of beer or 45 mL of spirit with 40% alcohol or 150 mL of wine), or those who could not guarantee the abandonment of drinking during the study, or subjects with positive result of alcohol breath test.
- •Subjects who smoke more than 5 cigarettes daily within 3 months prior to screening or those could not guarantee the abandonment of smoking during the study.
- •Those who have participated in any other drug clinical trial within 3 months prior to screening (with the last visit date of the trial considered as the starting time for time counting).
- •Those who donated blood or blood products of ≥400ml or 2 units within 3 months or had lost of ≥400 mL blood within 6 months prior to screening.
- •Those who do not agree to stop alcohol drinking or caffeinated beverages within 48 hours before the study drug administration and throughout the whole trial, or do not agree to stop strenuous exercise or to avoid other factors that may affect the drug absorption, distribution, metabolism, or excretion.
- •Women who are pregnant or lactating, or who have a positive pregnancy test before the study drug administration; or those who could not or do not take the requested effective contraceptive measures accepted by the investigator during the trial.
- •Subjects with difficulties in venous blood collection, fear of needles or hemophobia.
- •Other conditions that may not be suitable for participating in the study judged by the investigator.
Arms & Interventions
Single Ascending Dose Study
Healthy subjects will be screened and different doses of X842 will be administered in a single dose to assess the safety, tolerability, PK and PD profile of X842.
Intervention: Single ascending dose of X842 (Drug)
Multiple Ascending Dose Study
Healthy subjects will be screened and different doses of X842 will be administered in multiple doses to assess the safety, tolerability, PK and PD profile of X842. The dose ascending at this stage will be based on the results of the single dose tolerability study.
Intervention: Multiple ascending dose of X842 (Drug)
Food Effect Study
A randomized, open label, single-dose, self-controlled, double-cycle, two-way crossover clinical trial.
Intervention: Food Effect (Other)
Outcomes
Primary Outcomes
Vital signs of blood pressure
Time Frame: Five Weeks
Blood pressure measurements included systolic (mmHg) and diastolic (mmHg).
Number of clinically significant changes in Electrocardiograms (ECGs)
Time Frame: Five Weeks
The investigator or the sub-investigator interpreted the ECG using one of the following categories: "within normal limits", "abnormal but not clinically significant", or "abnormal and clinically significant".
Number of Clinically significant changes in lab assessment of blood serum
Time Frame: Five Weeks
Number of Clinically significant changes in the lab assessment of urine
Time Frame: Five Weeks
Vital signs of body temperature
Time Frame: Five Weeks
Occurrence and frequency of AEs after single and multiple doses of X842.
Time Frame: Five Weeks
Safety and tolerability will be assessed by occurrence and frequency of AEs. The adverse event assessment will follow the recommendations and grading system of Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Summary statistics will be applied.
Vital signs of respiratory rate
Time Frame: Five Weeks
Physical Examination of height
Time Frame: Five Weeks
Physical Examination of weight
Time Frame: Five Weeks
Number of Clinically significant changes in the lab assessment of blood
Time Frame: Five Weeks
Secondary Outcomes
- Measurement of the PK profile (t1/2)(Up to 48 hours after dosing)
- Measurement of the PK profile (Cmax)(Up to 48 hours after dosing)
- Measurement of the PD profile (intragastric pH)(Up to 24 hours after dosing)