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KB301

Phase 1

Skin Roughness | Monoclonal antibody | Dermatology |Krystal Biotech, Inc.|Last Updated: May 13, 2025

Success Probability

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Market & Valuation

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Trial Design

PLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

KB301 · 1 trial · 4 indications

Phase 1 1
NCT04540900A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin DepressionsSkin Roughness
ACTIVE NOT_RECRUITING85 Analytics
PHASE1ACTIVE NOT_RECRUITING
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
Skin RoughnessUnlock trial analytics

Study Endpoints

Primary Endpoints

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.
4 months

The primary outcome will look at the safety and tolerability of KB301 through the collection and quantification of adverse events, physical examinations, vital signs and clinical laboratory tests.

Secondary Endpoints

Evaluation of COL3A1 transgene expression 2-days post-dose.
12 months
Assessment of skin roughness as compared to baseline, using the Skin Roughness Scale (SRS).
65 Days
Assessment of fine line improvement as compared to baseline, using the Fine Lines Scale (FLS).
65 Days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
KB301ACTIVE_COMPARATORnon-integrating HSV-1 vector expressing human type III collagen
PlaceboPLACEBO_COMPARATORsterile isotonic saline

Interventions

NameTypeDescription
KB301BIOLOGICALnon-integrating HSV-1 vector expressing human type III collagen
PlaceboOTHERsterile isotonic saline
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: 1. 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) 2. Regions of suitable skin to be selected as Target Area(s), as determined by a physical examination conducted by the investigator du...

Countries:United States
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Frequently asked questions about KB301

What is KB301 used for?

KB301 is an investigational therapy being developed for the treatment of skin roughness, wrinkles, fine lines, and skin thickness issues. It is currently in Phase 1 clinical development for these dermatological conditions.

What does KB301 target?

KB301 is designed to express human type III collagen (COL3) in the skin. It is a replication-incompetent, non-integrating vector that delivers the COL3 gene to target cells, potentially addressing skin roughness and related conditions.

Who makes KB301?

KB301 is being developed by Krystal Biotech, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KRYS. The company is conducting clinical trials to evaluate the safety and efficacy of KB301.

What phase is KB301 in?

KB301 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 study is active but not recruiting participants.

What clinical trials is KB301 in?

KB301 is being studied in a Phase 1 clinical trial with the identifier NCT04540900. This trial is evaluating the therapy for skin roughness, wrinkles, fine lines, and skin thickness in healthy volunteers aged 18 years and older in the United States.

Is KB301 the same as a collagen treatment?

KB301 is a gene therapy that expresses human type III collagen (COL3) in the skin. It is designed to deliver the COL3 gene to target cells, potentially improving skin conditions such as roughness and fine lines.