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KB301

Phase 1

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

KB301 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2020

KB301 target and mechanism

Molecular targetCOL3A1
ModalityMonoclonal antibody

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

KB301 clinical trials

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 skin roughness, wrinkles, fine lines, and skin thickness. It is administered to treat superficial skin depressions. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does KB301 target?

KB301 targets COL3A1, the gene that encodes human type III collagen. The therapy is designed to express human type III collagen (COL3) to address skin conditions. It is being studied for its potential effects on skin roughness and related dermatological indications.

Who makes KB301?

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

What phase is KB301 in?

KB301 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The ongoing Phase 1 trial is active but not recruiting participants, indicating that enrollment has been completed and the study is continuing.

What clinical trials is KB301 in?

KB301 is being evaluated in a Phase 1 clinical trial registered as NCT04540900. This study is a placebo-controlled trial investigating KB301 for the treatment of superficial skin depressions, including skin roughness, wrinkles, and fine lines. The trial is active but not recruiting and has an enrollment of 85 participants.

Is KB301 the same as COL3?

KB301 is a therapy that expresses human type III collagen (COL3). It is designed to deliver the COL3A1 gene to produce type III collagen in the skin. While KB301 is the drug product, COL3 refers to the collagen protein it is intended to generate.