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

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.

Study Overview

• Status: Completed
• Conditions: Safety Issues
• Intervention / Treatment: Other: placebo; Drug: dexlansoprazole injection

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 Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Other: placebo
Experimental: Dexlansoprazole Injection	Drug: dexlansoprazole injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborators: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): March 9, 2017
• Study Completion (Actual): March 9, 2017

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 16, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: ASKC263-LC-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO