A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults (Part 1)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1 Double-blind, Dose-escalation, Placebo-controlled Tolerance Study in Healthy Chinese Adults After Single Intravenous Administration of Dexlansoprazole

Conditions
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Safety Issues

Intervention / Treatment
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* Drug: dexlansoprazole injection
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Other: placebo<br> <br> |
| Experimental: Dexlansoprazole Injection<br> | Drug: dexlansoprazole injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | 3 days |