Trial | NCT03011125  Report issue

Title

A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults (Part 1)
A Phase 1 Double-blind, Dose-escalation, Placebo-controlled Tolerance Study in Healthy Chinese Adults After Single Intravenous Administration of Dexlansoprazole

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Safety Issues

  • Intervention/Treatment

    dexlansoprazole ...

  • Study Participants

    28
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.
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.
Study Started
Jan 31
2017
Primary Completion
Mar 09
2017
Study Completion
Mar 09
2017
Last Update
Mar 16
2017

Drug dexlansoprazole injection

Other placebo

placebo Placebo Comparator

Dexlansoprazole Injection Experimental

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.
No Results Posted