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The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot

Status

Completed

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

WH-1 ointment

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring WH-1,Diabetic Foot,Ulcer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female is at least 20 years of age;
Diabetes mellitus (type I or II) was diagnosed with an HbA1c ≤ 12.0% measured during screening or within three months prior to randomization;
The target diabetic foot ulcer must have the following characteristics:
1. ≤ Grade 2 per Wagner Ulcer Classification System;
2. Lower limbs;
3. No-infected;
4. A cross-sectional area of between 1 and 25 cm2 post-debridement;
If female and of childbearing potential has a negative pregnancy test and is neither breastfeeding or intending to become pregnant during the study;
Able and willing to follow with study scheduled visits, comply with study procedures, and sign the informed consent.

Exclusion Criteria:

Acute Charcot' s neuroarthropathy as determined by clinical and/or radiographic examination;
Poor nutritional status defined as an albumin < 2.5 g/dL;
AST and/or ALT > 3X of the normal upper limit;
Clearance of Creatinine (Ccr) < 30 ml/min;
Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids within 4 weeks prior to enroll;
A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject' s medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance
Subjects who have received an experimental agent within 30 days, prior to enroll.
Subjects who have received WH-1 ointment within 30 days, prior to enroll.
Subjects who have history of smoking (define as more than 20 cigarettes per day) within 3 months prior to admission to the Hospital site.
Judged by the investigator not to be suitable for the study for any other reason.

Sites / Locations

Clinical Research Division

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WH-1 ointment

Arm Description

WH-1 ointment(1.25%),15g ointment per tube.

Outcomes

Primary Outcome Measures

Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ)

AUC0-∞, AUC0-t, Cmax: Area under the concentration-time curve from time 0 to infinity (AUC0-∞) Area under the concentration-time curve from 0 to the time of last quantifiable level (AUC0-t) Maximum observed level (Cmax) Cmax,ss, AUC0-τ: Maximum observed plasma concentration at steady state (Cmax,ss) Area under the concentration versus time curve from time zero to the end of a dosing interval (AUC0-τ).

Secondary Outcome Measures

Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F)

Time to peak concentration (Tmax) Mean residence time (MRT) Elimination half-life (T1/2) Apparent volume of distribution (Vd/F) Apparent clearance (CL/F)

Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss)

Time to peak concentration at steady state (Tmax,ss)

Full Information

NCT ID

NCT02353273

First Posted

January 21, 2015

Last Updated

March 26, 2018

Sponsor

Oneness Biotech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02353273

Brief Title

The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers

Official Title

The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

July 22, 2015 (Actual)

Primary Completion Date

July 5, 2016 (Actual)

Study Completion Date

September 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oneness Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study is to evaluate the systemic exposures of WH-1 ointment which includes Salvigenin and Asiaticoside A in subjects with chronic diabetic foot ulcers following topical application of WH-1.

Detailed Description

This trial is designed as an open label, non-comparative study to evaluate the pharmacokinetic profiles of salvigenin and asiaticoside A in subjects who received the treatment of WH-1 ointment for diabetic foot ulcers. A total of 12 subjects will be completed in study. Each subject will be applied the one dose of WH-1 ointment on Day 1 following with the blood sampling collection, then twice a day of WH-1 application from Day 2 to Day 13, and another blood sampling collection scheduled on Day 14 after one dose application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot

Keywords

WH-1,Diabetic Foot,Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WH-1 ointment

Arm Type

Experimental

Arm Description

WH-1 ointment(1.25%),15g ointment per tube.

Intervention Type

Drug

Intervention Name(s)

WH-1 ointment

Other Intervention Name(s)

No other intervention drug

Intervention Description

Each subject will be applied the one dose of WH-1 ointment on Day 1, and twice a day of WH-1 application from Day 2 to Day 13, then one dose for Day 14.

Primary Outcome Measure Information:

Title

Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ)

Description

Time Frame

Day1; Day14

Secondary Outcome Measure Information:

Title

Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F)

Description

Time to peak concentration (Tmax) Mean residence time (MRT) Elimination half-life (T1/2) Apparent volume of distribution (Vd/F) Apparent clearance (CL/F)

Time Frame

Day1

Title

Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss)

Description

Time to peak concentration at steady state (Tmax,ss)

Time Frame

Day14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female is at least 20 years of age; Diabetes mellitus (type I or II) was diagnosed with an HbA1c ≤ 12.0% measured during screening or within three months prior to randomization; The target diabetic foot ulcer must have the following characteristics: ≤ Grade 2 per Wagner Ulcer Classification System; Lower limbs; No-infected; A cross-sectional area of between 1 and 25 cm2 post-debridement; If female and of childbearing potential has a negative pregnancy test and is neither breastfeeding or intending to become pregnant during the study; Able and willing to follow with study scheduled visits, comply with study procedures, and sign the informed consent. Exclusion Criteria: Acute Charcot' s neuroarthropathy as determined by clinical and/or radiographic examination; Poor nutritional status defined as an albumin < 2.5 g/dL; AST and/or ALT > 3X of the normal upper limit; Clearance of Creatinine (Ccr) < 30 ml/min; Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids within 4 weeks prior to enroll; A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject' s medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance Subjects who have received an experimental agent within 30 days, prior to enroll. Subjects who have received WH-1 ointment within 30 days, prior to enroll. Subjects who have history of smoking (define as more than 20 cigarettes per day) within 3 months prior to admission to the Hospital site. Judged by the investigator not to be suitable for the study for any other reason.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kai-Min Chu

Organizational Affiliation

Tri-Service General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Division

City

Taipei

ZIP/Postal Code

115

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers

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