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

Zhejiang University

Status and phase

Completed

Phase 1

Conditions

Safety Issues

Treatments

Drug: dexlansoprazole injection

Other: placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03011125

ASKC263-LC-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.