Trials Sponsors Conditions Drugs Pricing

NCT04236635

CompletedPhase 2

Histopathology Following CCH Injection

Endo USA Inc., a Keenova Therapeutics Company Source

Conditions

Characteristics of Subcutaneous Tissue

Outcome Measures

Primary Outcomes (1)

Number of Participants With a Histologic Change in a Tissue Specimen That Was Injected With CCH
Tissue specimens isolated from participants undergoing an abdominoplasty procedure were observed for histopathological structure changes of tissues post treatment with CCH. The number of participants with a histologic change (as determined by the pathologist) in tissue dosed with CCH relative to control tissue (tissue not dosed with CCH) is reported.
Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)

Secondary Outcomes (3)

Number of Participants With a Histologic Change in a Tissue Specimen After 2 CCH Dose Injections Relative to a Tissue Specimen After 1 CCH Dose Injection
Up to collection of the excised abdominal tissue on Day 0 (day of abdominoplasty)
Number of Participants With Anti-AUX-I and Anti-AUX-II Anti-Drug Antibodies (ADAs) After CCH Treatment
End of Study (Day 28)
Number of Participants With Anti-AUX-I and Anti-AUX-II Neutralizing Antibodies (NAbs) After CCH Treatment
End of Study (Day 28)

Study Arms (6)

Group 1: CCH Single Injection Technique

EXPERIMENTAL

Participants were administered 0.07 milligrams (mg) CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -43 and -22. Area 2 was administered CCH on Day -14.

Drug: Collagenase Clostridium Histolyticum Single Injection Technique

Group 2: CCH Single Injection Technique

EXPERIMENTAL

Participants were administered 0.07 mg CCH subcutaneously using a single injection technique. Each participant had 2 marked areas (Area 1 and Area 2) of the abdomen selected for injection. Area 1 was administered CCH on Days -24 and -3. Area 2 was administered CCH on Day -3.

Drug: Collagenase Clostridium Histolyticum Single Injection Technique

Group 3: CCH Single Injection Technique

Interventions

Collagenase Clostridium Histolyticum Single Injection TechniqueDrug

CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.

Also known as: EN3835, CCH

Group 1: CCH Single Injection TechniqueGroup 2: CCH Single Injection TechniqueGroup 3: CCH Single Injection Technique

Collagenase Clostridium Histolyticum Multiple Injection TechniqueDrug

Eligibility Criteria

Age18 Years - 55 Years

Sexfemale(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Be adequately informed and understand the nature and risks of the study and be able to provide consent.
Be undergoing planned elective abdominoplasty.

Sponsors & Collaborators

Endo USA Inc., a Keenova Therapeutics Company
Industrylead

Study Sites (2)

Endo Clinical Trial Site #1

Montclair, New Jersey, 07042, United States

Endo Clinical Trial Site #2

New York, New York, 10021, United States

Limitations and Caveats

This was considered an exploratory study by the Sponsor. No formal sample size calculations were performed. Completion of 8 participants provided minimal data to meet the primary objective in the evaluable population.

Results Point of Contact

Title: Saji Vijayan, MBBS
Organization: Endo Pharmaceuticals

Study Officials

Karen Chajko
Endo USA Inc., a Keenova Therapeutics Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 2, 2020

First Posted

January 22, 2020

Study Start

December 20, 2019

Actual (reported)

Histopathology Following CCH Injection

Histopathology Following CCH Injection

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (6)

Group 1: CCH Single Injection Technique

Group 2: CCH Single Injection Technique

Group 3: CCH Single Injection Technique

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Group 4: CCH Multiple Injection Technique

Group 5: CCH Multiple Injection Technique

Group 6: CCH Multiple Injection Technique

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (6)

Group 1: CCH Single Injection Technique

Group 2: CCH Single Injection Technique

Group 3: CCH Single Injection Technique

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Group 4: CCH Multiple Injection Technique

Group 5: CCH Multiple Injection Technique

Group 6: CCH Multiple Injection Technique

You may not qualify if:

Data Sharing

Source record

Documents

Locations