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

Safety Issues Clinical Trial

Official title:

A Phase 1 Double-blind, Dose-escalation, Placebo-controlled Tolerance Study in Healthy Chinese Adults After Single Intravenous Administration of Dexlansoprazole

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011125
• Other study ID #: ASKC263-LC-1
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2017
• Last updated: March 15, 2017
• Start date: January 2017
• Est. completion date: March 9, 2017

Study information

• Verified date: January 2017
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 9, 2017
• Est. primary completion date: March 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Safety Issues

Intervention

Drug:
• dexlansoprazole injection

Other:
• placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University	Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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