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

NCT03011125 | Completed Phase 1

• 1 other identifier: ASKC263-LC-1
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

placebo

PLACEBO COMPARATOR

Other: placebo

Dexlansoprazole Injection

EXPERIMENTAL

Drug: dexlansoprazole injection

Interventions

dexlansoprazole injection DRUG

Dexlansoprazole Injection

placebo OTHER

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Jiangsu Aosaikang Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Interventions

Dexlansoprazole

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lihua Wu, Doctor

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 5, 2017
• Study Start: January 1, 2017
• Primary Completion: March 9, 2017
• Study Completion: March 9, 2017
• Last Updated: March 16, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share