A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type… (NCT04540900) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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
United States85 participantsStarted 2020-10-07
Plain-language summary
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
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female in good general health, as determined by the investigator, aged ≥18 and ≤75 at the time of consent (only females for Cohort 4)
✓. 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:
✓. A Fitzpatrick skin phototype score of I-IV
✓. A negative pregnancy test at the Study Day 0 Visit for subjects of child-bearing potential and
✓. Signed and dated informed consent and willingness to attend all study visits and complete all procedures required by this protocol.
Exclusion criteria
✕. 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
✕. History of laser treatment or chemical peels to the Target Areas within six (6) months of the Study Day 0 Visit
✕. 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
✕. Administration of a cosmetic and/or clinical research investigational agent, at the location of the Target Areas within 6 months of the Study Day 0 Visit, that, in the opinion of the investigator, may confound study results
✕. Scars, tattoos or tanned skin (defined as skin that is tanned from sun exposure or an applied skin color such as a spray tan) within the Target Area
What they're measuring
1
Assessment of the safety profile of KB301 by recording adverse events using MedDRA System Organ Class and Preferred Term and collection of other clinical study procedures.
✕. 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
✕. Women who are pregnant or nursing
✕. Subject who is unwilling to comply with contraception requirements per-protocol