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

Phase 1

Completed

• Conditions: Safety Issues
• Interventions: Drug: dexlansoprazole injection; Other: placebo

• Registration Number: NCT03011125
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Primary Completion: 2017-03-09
• Study Completion: 2017-03-09
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexlansoprazole Injection	dexlansoprazole injection	-
placebo	placebo	-

Primary Outcome Measures

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