A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions

This is an interventional treatment trial for Skin Roughness focused on measuring KB301, Wrinkles, Krystal Biotech Read More

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 the initial visit:

   • Cohort 1 - region of healthy buttock skin
   • Cohort 1a - bilaterally symmetric regions of healthy buttock skin at least 6 cm apart
   • Cohort 2 - bilaterally symmetric regions of moderate to severe fine lines and skin roughness (score of 2 or 3), as determined by investigator using the 5-point FLS and SRS on the cheeks above and below the zygomatic arch

   • Cohort 2 Extension- A subject who received a high dose regimen of KB301 to Target Areas below the zygomatic arch

     • Treatment group- Unilateral region of the cheek below the zygomatic arch, which was randomized to received placebo under Cohort 2, that per investigator assessment and consultation with the sponsor at Visit 1, is determined to be uneven as compared to the Target Area which received KB301
     • Observational group - Bilateral region of the cheeks below the zygomatic arch which were randomized to receive high dose 301 under Cohort 2 that show durability of KB301 to at least one of the two Target Areas
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 and
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 at Day 0 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 (6) 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, at the location of the Target Areas within 3 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. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol, in the opinion of the investigator.