Intervention: 4Rnu8C6xxw
Trial phase: Phase 2
SMILES: CC(C)(C)NC(=O)N1CC(OC(c2ccc(Cl)cc2)c2ccccc2C(F)(F)F)C1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: 4th Dose in escalation paradigm, 6.7X Dose 1.

Injection of active drug into the pectoralis muscle.
Eligibility criteria:
Inclusion Criteria:

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
Able to speak, read, and understand the language of the informed consent form (ICF) and study questionnaires

Exclusion Criteria:

History of surgical procedure involving the breast, including, but not limited to, breast augmentation. History of minor localized breast biopsy is not exclusionary if it occurred at least 1 year prior to the screening visit, and if considered not clinically significant in the opinion of the investigator.
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
Current enrollment in an investigational drug or device study or participation in such a study within 30 days or 5 half-lives of the drug, whichever is longer, of entry into this study
Subject plans to donate blood or plasma from 30 days prior to screening until last follow-up visit (Day 29)
Reported pain score of 2 or more at screening on the 11-point scale NPRS-A following strength testing with PM activation