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

NCT ID: NCT03011125

Last Updated: 2017-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-03-09

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.

Conditions

Safety Issues

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Dexlansoprazole Injection

Group Type: EXPERIMENTAL

dexlansoprazole injection

Intervention Type: DRUG

Interventions

dexlansoprazole injection

Intervention Type: DRUG

placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Aosaikang Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lihua Wu, Doctor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Other Identifiers

ASKC263-LC-1

Identifier Type: -

Identifier Source: org_study_id