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

Phase 1

Completed

• Conditions: Diabetic Foot
• Interventions: Drug: WH-1 ointment

• Registration Number: NCT02353273
• Lead Sponsor: Oneness Biotech Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-02
• Study Start: 2015-07-22
• Primary Completion: 2016-07-05
• Study Completion: 2016-09-05
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Male or female is at least 20 years of age;

2. Diabetes mellitus (type I or II) was diagnosed with an HbA1c ≤ 12.0% measured during screening or within three months prior to randomization;

3. 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;

4. If female and of childbearing potential has a negative pregnancy test and is neither breastfeeding or intending to become pregnant during the study;

5. Able and willing to follow with study scheduled visits, comply with study procedures, and sign the informed consent.

Exclusion Criteria

1. Acute Charcot' s neuroarthropathy as determined by clinical and/or radiographic examination;
2. Poor nutritional status defined as an albumin < 2.5 g/dL;
3. AST and/or ALT > 3X of the normal upper limit;
4. Clearance of Creatinine (Ccr) < 30 ml/min;
5. Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids within 4 weeks prior to enroll;
6. 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
7. Subjects who have received an experimental agent within 30 days, prior to enroll.
8. Subjects who have received WH-1 ointment within 30 days, prior to enroll.
9. Subjects who have history of smoking (define as more than 20 cigarettes per day) within 3 months prior to admission to the Hospital site.
10. Judged by the investigator not to be suitable for the study for any other reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ)	Day1; Day14	AUC0-∞, AUC0-t, Cmax: 1. Area under the concentration-time curve from time 0 to infinity (AUC0-∞); 2. Area under the concentration-time curve from 0 to the time of last quantifiable level (AUC0-t); 3. Maximum observed level (Cmax); Cmax,ss, AUC0-τ: 1. Maximum observed plasma concentration at steady state (Cmax,ss); 2. Area under the concentration versus time curve from time zero to the end of a dosing interval (AUC0-τ).

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F)	Day1	1. Time to peak concentration (Tmax); 2. Mean residence time (MRT); 3. Elimination half-life (T1/2); 4. Apparent volume of distribution (Vd/F); 5. Apparent clearance (CL/F)
Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss)	Day14	Time to peak concentration at steady state (Tmax,ss)

Trial Locations

Locations (1)

Clinical Research Division; 🇨🇳 Taipei, Taiwan