Safety and Efficacy of MRG-001 in Wound Healing in Abdominoplasty Patients

Inclusion Criteria:

1. Subject voluntarily agrees to participate in this study and signs an InstitutionalReview Board (IRB)-approved informed consent (which includes the PhotographicRelease Form and HIPAA) prior to performing any of the Screening Visit procedures.

2. Outpatient, males and females between 18 to 55 years of age, inclusive, at the timeof signing the ICF. Female subjects of childbearing potential must have a negativeserum pregnancy test at Visit 1a (Study Part A) and 1b (Study Part B) and practice areliable method of contraception throughout the study.

3. Seeking or scheduled for standard elective abdominoplasty.

4. Willing to undergo directed excisions under local anesthesia and follow-up priorabdominoplasty and to undergo all follow-up visits after abdominoplasty surgery.

5. Nonsmokers (or other nicotine use) as determined by history (no nicotine use overthe past 6 months) and by urine cotinine concentration (< 200 ng/mL) at theScreening Visit and prior to admission.

6. Generally, in good health with no clinically significant abnormalities as determinedby medical, history, physical examination, 12-lead ECG and clinical laboratorytests.

7. The following applies to female subjects of childbearing potential:

• Non-pregnant, non-lactating females of childbearing potential who agree to usemedically acceptable forms of birth control (hormonal contraception, abstinence,diaphragm with spermicide, condom with spermicide or intrauterine device) from theScreening Visit until the End-of-study Visit.

8. Body mass index (BMI) between 25 and 35.0 kg/m2, inclusive, at the Screening Visit.

9. Men must be willing to use double-barrier contraception from enrollment until 8weeks after the last dose of the study drug, if not abstinent.

Exclusion Criteria:

1. Participation in any other clinical trial of an experimental treatment or used aninvestigational drug within the past 30 days.

2. Subject has a clinically significant history or evidence of cardiovascular,respiratory, hepatic, renal, gastrointestinal, endocrine, neurological,immunological, hematological or psychiatric disorder(s) as determined by thePrincipal Investigator or designee.

3. History of diabetes mellitus or an HbA1C greater than 5.7 percent.

4. History of prior abdominal surgery or abdominal liposuction, cryolipolysis, focusedultrasound or other fat reduction procedures in or near the anterior abdomen within 12 months prior to screening.

5. History of poor or delayed wound healing such as prior wound dehiscence, chronicwound or leg ulcer.

6. History of or evidence of a genetic collagen disorder such as Ehlers-DanlosSyndrome.

7. Operating Physician is unable to design an abdominoplasty incision area of at least 25 cm wide by 12 cm tall at the center of the fusiform.

8. The presence of any abnormality of the skin within the area of the proposedabdominoplasty that, in the opinion of the PI, could interfere with the excisionprocess or grading of the resultant surgical scar (e.g., striae gravidarum, striaedistensae, excessive nevi, numerous seborrheic keratoses, tattoos, etc.).

9. History of splenectomy or splenomegaly (spleen weighing >750 g).

10. Currently taking immunomodulating drugs (e.g, interferons, interleukin, JAK1/2inhibitors/corticosteroids).

11. Female subjects who are pregnant or breastfeeding or planning to breastfeed at anytime through 90 days after last dose of IP.

12. History of alcohol and/or illicit drug abuse within 2 years of entry.

13. History of hypersensitivity to MRG-001's components (tacrolimus or plerixafor) orhypersensitivity or intolerance to local anesthetics.

14. Any personal, familial, employment or financial situation that could impede thesubject's ability to attend all study visits and successfully complete the entireclinical study.

15. Unable to understand the protocol requirements, instructions and study-relatedrestrictions, the nature, scope and possible consequences of the clinical study.

16. Unlikely to comply with the protocol requirements, instructions and study-relatedrestrictions; e.g., uncooperative attitude, inability to return for follow-up visitsand improbability of completing the clinical study.

17. Subjects defined as individuals whose willingness to volunteer in a clinical studymay be unduly influenced by the expectation, whether justified or not, of benefitsassociated with participation, or of a retaliatory response from senior members of ahierarchy in case of refusal to participate (e.g., vulnerable populations, personsin detention, minors and those incapable of giving consent).