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

NCT02353273 | Completed Phase 1

• 1 other identifier: ON101CLPK01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

WH-1,Diabetic Foot,Ulcer

Outcome Measures

Primary Outcomes (1)

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

  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).

  Day1; Day14

Secondary Outcomes (2)

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

  Day1

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

  Day14

Study Arms (1)

WH-1 ointment

EXPERIMENTAL

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

Drug: WH-1 ointment

Interventions

WH-1 ointment DRUG

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.

Also known as: No other intervention drug

WH-1 ointment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oneness Biotech Co., Ltd.: lead

Study Sites (1)

Clinical Research Division

Taipei, 115, Taiwan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Kai-Min Chu

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 2, 2015
• Study Start: July 22, 2015
• Primary Completion: July 5, 2016
• Study Completion: September 5, 2016
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

TW (1)