A Study of KB301 in Adults With Shallow to Moderately Deep Facial Wrinkles and Severe Atrophic Acne Scars.
A Study of KB301 in Adults With Shallow to Moderately Deep Facial Wrinkles and Severe Atrophic Acne Scars.
A Phase I Study of KB301 in adults with shallow-to-moderately deep facial wrinkles and severe
 atrophic acne scars.
Twenty-two (22) subjects divided into three (3) cohorts are planned for this Phase I study.
 Subjects enrolled in Cohort I will present a region of healthy buttock skin as a non-facial
 target area to receive two (2) injectable doses of KB301 (low or high). The objective of this
 cohort is to evaluate COL3A1 transgene expression (as measured by qRT-PCR of skin biopsies)
 and determine the optimal dose for the next 2 cohorts. Subjects enrolled in Cohort II will
 present two (2) bilaterally symmetrical areas of shallow-to-moderately deep facial wrinkles
 as the target areas; these areas will be randomly assigned to receive either KB301 or a
 placebo to determine the extent of wrinkle improvement in the KB 301 arm. Subjects enrolled
 in cohort III will present two (2) bilaterally symmetrical areas of severe atrophic acne
 scars as the target areas; these areas will be randomly assigned to receive either KB301 or a
 placebo to determine the extent of acne scar severity improvement in the KB301 arm.
 Throughout the study participants will complete questionnaires, have images captured of the
 target areas, undergo physical examinations, and have safety labs monitored.
Inclusion Criteria:

 1. Male or female in good general health, as determined by the Investigator, aged ≥18 and
 ≤75 at the time of consent.

 2. Regions of suitable skin to be selected as Target Area(s), as determined by a physical
 examination conducted by the Investigator during a screening visit

 1. Cohort 1 - single region of healthy buttock skin;

 2. Cohort 2 -two bilaterally symmetrical regions of shallow-to-moderately deep
 facial wrinkles; and

 3. Cohort 3 - two bilaterally symmetrical regions of moderate-to-severe atrophic
 acne scars.

 3. A Fitzpatrick skin phototype score of I-IV.

 4. A negative pregnancy test at the Study Day 0 Visit for subjects of child-bearing
 potential.

 5. Signed and dated informed consent and willingness to attend all study visits and
 complete all procedures required by this protocol.

 Exclusion Criteria:

 1. Any transient or chronic skin condition, disorder, or infection within 20 cm of the
 Target Areas that, in the opinion of the Investigator, may confound study results.

 2. History of laser treatment or chemical peels to the Target Areas within six months of
 the Study Day 0 Visit.

 3. History of surgical procedures to Target Areas, including removal of benign or
 malignant skin cancers that, in the opinion of the Investigator, may confound study
 results.

 4. Administration of a cosmetic and/or clinical research investigational agent, excluding
 KB301, in close proximity to the Target Areas within 12 months of the Study Day 0
 Visit, that, in the opinion of the Investigator, may confound study results.

 5. Any condition (including a history or current evidence of substance abuse or
 dependence) that, in the Investigator's opinion, would impact subject's ability to
 complete all study-related procedures and/or poses an additional risk to the
 assessment of safety of the Investigational Product.

 6. An active oral herpes infection at the Screening Visit or Study Day 0 Visit.

 7. Women who are pregnant or nursing.

 8. Subject who is unwilling to comply with contraception requirements per protocol.

 9. A history of anaphylaxis or allergic reactions to any of the constituents of the
 product and/or local anesthetics.

 10. Clinically significant abnormalities of hematology or chemistry testing at screening
 visit that the Investigator believes may interfere with the assessment of safety
 and/or efficacy of the study treatment.

 11. Subject is known to be noncompliant or is unlikely to comply with the requirements of
 the study protocol, in the opinion of the Investigator.