Evaluation of ATx201 as a Topical Antibiotic Agent

NCT03009734 | Completed Phase 1 DMC

• 1 other identifier: DECOLAD
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

AntibioTx is developping ATx201 as a topical product for treatment of skin infections, including infected atopic dermatitis.

Conditions

Infection, Bacterial

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of new topical formulations of ATx201

  Number of subjects with treatment related adverse events. AEs will be classified into standardised terminology from the verbatim description (Investigator term) according to the MedDRA Coding Dictionary. AEs will be classified by MedDRA term and associated system organ class. The number and percentage of subjects reporting AEs will be summarised by treatment group, system organ class, MedDRA term, and Phase.

  7 days

Secondary Outcomes (4)

• Assessment of the impact of ATx201 on the treated atopic dermatitis lesion. To determine the systemic exposure of ATx201.

  4 and 7 days

• Treatment success, defined as a 100-fold reduction in the S. aureus colony count / cm2 of sampled skin lesion

  4 and 7 days

• Local dermal tolerability at the sites of application

  7 days

• Safety and tolerability of new topical formulations of ATx201

  4 and 15 days

Study Arms (3)

ATx201 (2% dermal formulation A) and Placebo

OTHER

Drug: ATx201 dermal formulations 2%

ATx201 (2% dermal formulation B) and Placebo

OTHER

Drug: ATx201 dermal formulations 2%

ATx201 (2% dermal formulation C) and Placebo

OTHER

Drug: ATx201 dermal formulations 2%

Interventions

ATx201 dermal formulations 2% DRUG

Topical application of ATx201 dermal formulations 2%

ATx201 (2% dermal formulation A) and Placebo; ATx201 (2% dermal formulation B) and Placebo; ATx201 (2% dermal formulation C) and Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent has been obtained
• Age 18 - 70 years
• Male or female
• Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior trial treatment
• Female subjects of childbearing potential must be willing to use effective contraceptive at trial entry until completion
• Male subjects must agree to use adequate contraception for the duration of the trial
• Localized disease (e.g. flexural eczema in a more or less symmetrical distribution on arms) where two individual lesions each covering an area between 10-200 cm2 and where each individual lesion has an investigators global assessment score between 1-3.
• Additional localized lesion of area between 10-200 cm2 and where the individual lesion has an investigators global assessment score between 1-3.
• Total localized disease not exceeding 20 % body surface area
• Colonization of lesions with S.aureus as determined by cultivation

You may not qualify if:

• Clinically relevant abnormalities in the laboratory testing, vital signs, ECG ( Phase I only) or physical examination
• Presence of any skin condition (scars, tattoos,…) that would interfere with the placement of study medication
• History of irritation to topical products
• Current acute or chronic disease unless considered clinically irrelevant by the Investigator
• Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin (particularly at the site of drug application), haematological, endocrine or neurological diseases that may interfere with the aim of the study
• Positive HIV serology or evidence of active hepatitis
• Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drugs (test, reference)
• History of drug or alcohol abuse (\>2 drinks/day, defined according to USDA Dietary Guidelines 2005)
• caffeine (\>5 cups coffee/tea/day) or tobacco abuse (consumption of 5 or more cigarettes/week)
• abnormal or special diet (e.g. vegetarian diet)
• Blood donations during 6 weeks prior to this study or planned within 6 weeks after the last blood withdrawal
• Subject considered unable or unlikely (per Investigator judgment) to comply with safety and PK profiling requirements (follow-up visits)
• Subjects who are pregnant (as determined by a positive pregnancy test at the screening visit) or lactating
• Participation in another clinical trial with an investigational day within 4 weeks before screening
• Regular use of medications

Sponsors & Collaborators

• UNION therapeutics: lead

Study Sites (1)

Department of Clinical Pharmacology, General Hospital of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Markus Zeitlinger, MD

  General Hospital Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 4, 2017
• Study Start: December 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

AU (1)