INCB160058 - Healthy Participants | Phase 1 | Incyte Corporation | BiopharmaWatch

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INCB160058

Phase 1

Healthy Participants | Small molecule | Other |Incyte Corporation|Last Updated: Oct 14, 2025

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker

Total Trials1

Total Enrollment137

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT06213818	A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participant	PHASE1	COMPLETED	137	—	—	Mar 14, 2024	Aug 19, 2025	Oct 14, 2025	1	Australia

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Study Endpoints

Primary Endpoints

Number of participants with Treatment Emergent Adverse Events (TEAEs)

Up to Day 28

Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

INCB160058 pharmacokinetic (PK) when administered as solid tablets in Plasma

Up to Day 5

INCB160058 concentration in plasma.

INCB160058 pharmacokinetic (PK) when administered as a soft gel capsule in Plasma

Up to Day 5

INCB160058 concentration in plasma.

INCB160058 pharmacokinetic (PK) when administered as ASD tablets in Plasma

Up to Day 5

INCB160058 concentration in plasma.

INCB160058 pharmacokinetic (PK) in Plasma to determine the effect of food administered as solid tablets

Up to Day 12

INCB160058 concentration in plasma.

INCB160058 pharmacokinetic (PK) in Plasma to determine the effect of food administered as ASD tablets

Up to Day 12

INCB160058 concentration in plasma.

INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of esomeprazole administered as solid tablets

Up to Day 14

INCB160058 concentration in plasma.

INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of esomeprazole administered as ASD tablets

Up to Day 14

INCB160058 concentration in plasma.

INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of famotidine administered as solid tablets

Up to Day 14

INCB160058 concentration in plasma.

INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of famotidine administered as ASD tablets

Up to Day 14

INCB160058 concentration in plasma.

Secondary Endpoints

Additional INCB160058 pharmacokinetic (PK) in Plasma

Up to Day 14

INCB160058 pharmacokinetic (PK) in Urine

Up to Day 5

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Study Design & Arms

AllocationRANDOMIZED

MaskingDOUBLE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Cohort 1: Dose	EXPERIMENTAL	INCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 2: Dose	EXPERIMENTAL	INCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 3: Dose	EXPERIMENTAL	INCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 4: Dose	EXPERIMENTAL	INCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 5: Dose	EXPERIMENTAL	INCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 6: Dose Treatment A	EXPERIMENTAL	INCB160058 will be administered at protocol defined dose after an overnight fast.
Cohort 6: Dose Treatment B	EXPERIMENTAL	INCB160058 will be administered at protocol defined dose after a high-fat, high-calorie meal.
Cohort 7: Dose	EXPERIMENTAL	INCB160058 and esomeprazole will be administered at protocol defined schedule and dose.
Cohort 8: Dose	EXPERIMENTAL	INCB160058 will be administered at protocol defined dose after an overnight fast.
Cohort 9: Dose	EXPERIMENTAL	INCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 10: Dose Treatment A	EXPERIMENTAL	INCB160058 will be administered at protocol defined dose after an overnight fast.
Cohort 10: Dose Treatment B	EXPERIMENTAL	INCB160058 will be administered at protocol defined dose after a high-fat, high-calorie meal.
Cohort 11: Dose	EXPERIMENTAL	INCB160058 and esomeprazole will be administered at protocol defined schedule and dose.
Cohort 12: Dose	EXPERIMENTAL	INCB160058 and famotidine will be administered at protocol defined schedule and dose.
Cohort 13: Dose	EXPERIMENTAL	INCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 14: Dose	EXPERIMENTAL	INCB160058 and famotidine will be administered at protocol defined schedule and dose.
Cohort 15: Dose	EXPERIMENTAL	INCB160058 or placebo will be administered at protocol defined dose after an overnight fast.

Interventions

Name	Type	Description
INCB160058	DRUG	Oral; Immediate release solid tablet
Placebo	DRUG	Oral; Tablet
Esomeprazole	DRUG	Oral; Delayed-release capsule or tablet
Famotidine	DRUG	Oral; Tablet

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Eligibility Criteria

Age Range18 Years — 55 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Age 18 to 55 years, inclusive, at the time of signing the ICF. * Body mass index between 18.0 and 32.0 kg/m2 (inclusive). * Willingness to adhere to study-related prohibitions, restrictions, and proce...

Countries:Australia

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