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KB304

Phase 1

Wrinkles in Decolletage | Monoclonal antibody | Dermatology |Krystal Biotech, Inc.|Last Updated: May 13, 2025

Target and mechanism

Molecular targetCOL3A1/ELN
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

KB304 · 1 trial · 3 indications

Phase 1 1
NCT06724900A Study Assessing KB304 for the Treatment of Wrinkles in WomenWrinkles in Decolletage
ACTIVE NOT_RECRUITING19 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study Assessing KB304 for the Treatment of Wrinkles in Women
Wrinkles in DecolletageUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of KB304 versus placebo administered by intradermal injection
Up to 4 months

Treatment related adverse events as assessed by CTCAE

Secondary Endpoints

To evaluate the effect of KB304 versus placebo on dynamic wrinkles of the décolleté area.
Up to 4 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
KB304EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
KB304BIOLOGICALGenetically modified herpes simplex type 1 virus
0.9% Normal Saline (NS)DRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 75 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Female in good general health, as determined by the Investigator, aged ≥18 and ≤75 at the time of consent. * Presence of moderate to severe dynamic wrinkles in the décolleté Target Area, as determined by the Investigator on the JDWS. * A Fitzpatrick skin phototype score of I-I...

Countries:United States
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Frequently asked questions about KB304

What is KB304 used for?

KB304 is an investigational monoclonal antibody being developed for the treatment of wrinkles in the décolletage, also known as the chest area. It is being studied in women with décolleté wrinkles and pigmentation. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does KB304 target?

KB304 targets COL3A1 and ELN, which are proteins associated with collagen and elastin production in the skin. By targeting these molecular pathways, the drug is intended to address wrinkles in the décolletage area. This mechanism is being evaluated in an early-stage clinical trial for safety and efficacy.

Who is developing KB304?

KB304 is being developed by Krystal Biotech, Inc., a biopharmaceutical company. The company is conducting clinical research on this investigational drug for dermatological use. Krystal Biotech is publicly traded under the ticker symbol KRYS on the stock market.

What phase is KB304 in?

KB304 is in Phase 1 clinical development. The drug is being studied in an early-stage trial to assess its safety and tolerability in women with wrinkles in the décolletage. As an investigational agent, KB304 has not yet received approval from the U.S. Food and Drug Administration or other regulatory bodies.

What clinical trials is KB304 in?

KB304 is being evaluated in a Phase 1 clinical trial registered as NCT06724900. This study is assessing the treatment of wrinkles in women and is currently active but not recruiting participants. The trial is enrolling 19 healthy female volunteers aged 18 years and older in the United States.

Is KB304 the same as other wrinkle treatments?

KB304 is a distinct investigational monoclonal antibody developed by Krystal Biotech. It is being studied specifically for wrinkles in the décolletage, a condition that differs from facial wrinkles. The drug's mechanism targets COL3A1 and ELN, which may differentiate it from other wrinkle treatments, though comparative data is not yet available.