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Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers

NCT ID: NCT04654065

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2021-01-05

Brief Summary

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To evaluate whether IN-C004 absorbs oral mucosa in healthy volunteers.

Detailed Description

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An Open-label, Single-dose Clinical Study

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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IN-C004

IN-C004

Group Type EXPERIMENTAL

IN-C004

Intervention Type DRUG

One time dose of IN-C004 taken orally.

Interventions

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IN-C004

One time dose of IN-C004 taken orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening.

Exclusion Criteria

* History or evidence of clinically significant disease
* History of drug/alcohol abuse
* Participated in other studies and received investigational products within 6 months prior to the first study dose.
* Not able to use a medically acceptable contraceptive method throughout the study.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min-Gul Kim

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Chonbuk National University Hospital

Jeonju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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IN_KOD_101

Identifier Type: -

Identifier Source: org_study_id