Study to Evaluate EB-001 in Reducing Musculoskeletal Pain

NCT03193593 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: EB001-MA201
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety and efficacy of single intra-operative treatment of EB-001 IM injections into the Pectoralis Major (PM) in subjects undergoing breast augmentation with subpectoral implants

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Subject's Assessment of Pain Using the Numeric Pain Rating Scale (AUC16h-96h)

  Subject's assessment of pain using the Numeric Pain Rating Scale (1= No Pain, 10= Maximum Pain) for the first 96 hours following injection, expressed as AUC over the 16h to 96h period following dosing.

  16 hours to 96 hours following dosing

Study Arms (7)

Placebo Injections

PLACEBO COMPARATOR

Intervention: Drug: Placebo Single Saline Injection into the Pectoralis Muscle

Drug: Placebo

EB-001 Dose 1

ACTIVE COMPARATOR

Intervention: Drug: EB-001 1st Dose in escalation paradigm. Single Injection of active drug into the pectoralis muscle

Drug: EB-001

EB-001 Dose 2 (1.6X)

ACTIVE COMPARATOR

Intervention: Drug: EB-001 2nd Dose in escalation paradigm, 1.6X Dose 1. Single Injection of active drug into the pectoralis muscle

Drug: EB-001

EB-001 Dose 3 (3.3X)

ACTIVE COMPARATOR

Intervention: Drug: EB-001 3rd Dose in escalation paradigm, 3.3X Dose 1. Single Injection of active drug into the pectoralis muscle

Drug: EB-001

EB-001 Dose 4 (6.7X)

ACTIVE COMPARATOR

Intervention: Drug: EB-001 4th Dose in escalation paradigm, 6.7X Dose 1. Single Injection of active drug into the pectoralis muscle

Drug: EB-001

EB-001 Dose 5 (10X)

ACTIVE COMPARATOR

Intervention: Drug: EB-001 5th Dose in escalation paradigm, 10X Dose 1. Single Injection of active drug into the pectoralis muscle

Drug: EB-001

EB-001 Dose 6 (13.3X)

ACTIVE COMPARATOR

Intervention: Drug: EB-001 6th Dose in escalation paradigm, 13.3X Dose 1. Single Injection of active drug into the pectoralis muscle

Drug: EB-001

Interventions

Placebo DRUG

Placebo- Single injection of saline into Pectoralis Muscle

Placebo Injections

EB-001 DRUG

Single injection of EB-001 into Pectoralis Muscle

EB-001 Dose 1; EB-001 Dose 2 (1.6X); EB-001 Dose 3 (3.3X); EB-001 Dose 4 (6.7X); EB-001 Dose 5 (10X); EB-001 Dose 6 (13.3X)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18 to 55 years of age, inclusive
• Women who are in good health as determined by medical history, physical examination, clinical laboratory studies, ECGs, vital signs, and Investigator judgment
• Scheduled to undergo primary breast augmentation under general anesthesia (endotracheal or otherwise) with:
• Sub-pectoral implants placement,
• Infra-mammary surgical approach,
• Implant size between 250 and 400cc and
• Non-textured saline breast implants
• American Society of Anesthesiologist (ASA) Physical Class 1-2
• Women of non-childbearing potential or postmenopausal (at least 12 consecutive months of amenorrhea)
• Women of childbearing potential must not be pregnant, lactating, or planning to become pregnant during the study
• Women of childbearing potential agreeing to use either:
• a highly effective method of contraception with failures rates less than 1% per year such as implant, intrauterine device (IUD), or confirmed sterilization and sterilization procedure at least 3 months prior to the day of dosing
• dual methods of contraception with overall failures rate less than 1% per year such as injectable, pill, patch, ring, and diaphragm from the day of dosing for 3 months (subjects using oral contraception must have initiated treatment at least 2 months prior to the day of dosing)
• Willing and able to complete protocol requirements and instructions, which includes completion of all required visits, procedures and in-clinic stays until the end of the study
• Willing and able to sign and date IRB-approved informed consent

You may not qualify if:

• Pre-existing lung disease that could impact subject safety in the opinion of the investigator
• History of smoking within the past two years
• Slow vital capacity that is below 80% of normal value for respective race, age, height, and gender
• Pulse oximetry below 95%
• Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32
• Documented diagnosis of chronic pain condition, or other painful pre-operative condition that, in the opinion of the investigator, may require analgesic treatment in the post-operative period (e.g. significant joint pain, neuropathic pain)
• Known hypersensitivity to any botulinum toxin serotype or to any component of the formulation
• Reported use of any botulinum toxin within 3 months prior to the date of surgery
• Anticipated use of any botulinum toxin of any serotype during the study
• Use of long acting opioids within 3 days or any opioid medication within 24 hours prior to surgery
• Aminoglycoside intake within 48 hours prior to or during surgery
• Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis)
• Any past or current medical condition that in opinion of investigator, puts subject at undue safety risk for surgical complications or for use of the investigational product.
• Any clinically significant psychiatric condition that, in opinion of investigator, may interfere with study assessments or protocol compliance
• History of alcohol or drug abuse in the last 3 years, based on investigator judgement

Sponsors & Collaborators

• Bonti, Inc.: lead

Study Sites (1)

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Wajdie Ahmad
• Organization: Bonti

wajdie@bonti.com

9493796569

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: August 29, 2017
• Primary Completion: April 26, 2018
• Study Completion: August 7, 2018
• Last Updated: January 25, 2019
• Results First Posted: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)