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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03011125

Enrollment

Registered

2017-01-05

Start date

2017-01-31

Completion date

2017-03-09

Last updated

2017-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety Issues

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.

Interventions

DRUGdexlansoprazole injection

OTHERplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	3 days	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026