A Phase 1 Double-blind, Dose-escalation, Placebo-controlled Tolerance Study in Healthy Chinese Adults After Single Intravenous Administration of Dexlansoprazole
Overview
- Phase
- Phase 1
- Intervention
- placebo
- Conditions
- Safety Issues
- Sponsor
- First Affiliated Hospital of Zhejiang University
- Enrollment
- 28
- Primary Endpoint
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a single center, randomized, double-blind, dose-escalation, placebo-controlled phase 1 clinical trial. This study will determine the safety and side-effect profile of an investigational dexlansoprazole injection after single intravenous administration in healthy Chinese adults.
Detailed Description
This is a single center, double-blind, dose-escalation, placebo-controlled clinical trial. Dose escalation will be proceeded according to 3+3 design in five predefined dosing groups. After completion of the 90mg dosing study, dose-escalation will be stopped, even though MTD is not be observed. A total of 28 participants is scheduled to be recruited. The whole follow-up period for each participant will be 3 days.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 Years;
- •Male (weight ≥50kg) or female (weight ≥45kg);
- •BMI between 19\~28 kg/m2;
- •Healthy subjects (at screening);
- •Subject who totally understand the aim and progress of this clinical trial, make decision by his/her free will, and signed a consent form to follow the progress.
Exclusion Criteria
- •Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;
- •Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;
- •Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values;
- •HIV, HBV, or syphilis positive;
- •Drug dependency or abuse;
- •Heavy smokers (\>5 cigarettes per day);
- •Alcohol use;
- •Participation in another study with an investigational drug within the last 3 months preceding this study;
- •Blood donation within the last 2 months (\>= 400 ml), or have a plan to donate blood within 1 month after this study;
- •Intake of any other drug which might influence the results of the trial during two weeks previous to the start of the study.
Arms & Interventions
placebo
Intervention: placebo
Dexlansoprazole Injection
Intervention: dexlansoprazole injection
Outcomes
Primary Outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 3 days
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment