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CompletedNCT03011125Updated Mar 16, 2017

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

A Phase 1 interventional study of dexlansoprazole injection and placebo in Safety Issues, sponsored by First Affiliated Hospital of Zhejiang University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-16.

Sponsored by First Affiliated Hospital of Zhejiang University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Safety Issues
03

In context

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (estimated)

Study arms

  • Placebo comparator
    placebo

    Other: placebo

  • Experimental
    Dexlansoprazole Injection

    Drug: dexlansoprazole injection

Interventions

  • Drugdexlansoprazole injection
  • Otherplacebo
06

What researchers measure

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

    Time frame: 3 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03011125
Lead sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 5, 2017
Start date
Jan 2017
Primary completion
Mar 9, 2017
Completion
Mar 9, 2017
Last update
Mar 16, 2017

Study contacts

Lihua Wu, Doctor
principal investigator · First Affiliated Hospital of Zhejiang University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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