CRN04894 - Healthy Volunteers | Phase 1 | Crinetics Pharmaceuticals, Inc. | BiopharmaWatch

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CRN04894

Phase 1

Healthy Volunteers | Small molecule | Other |Crinetics Pharmaceuticals, Inc.|Last Updated: Sep 21, 2023

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 Enrollment88

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT06048887	Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers	PHASE1	COMPLETED	88	—	—	Dec 18, 2020	Apr 11, 2022	Sep 21, 2023	1	United States

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Study Endpoints

Primary Endpoints

Percentage of subjects with treatment-emergent adverse events

Part 1 - up to Day 8; Part 2 - up to Day 20

Proportion of participants with a clinically significant safety laboratory observation

Part 1 - up to Day 8; Part 2 - up to Day 20

Secondary Endpoints

Pharmacokinetics (AUC)

Part 1 - up to Day 8; Part 2 - up to Day 20

Pharmacokinetics (Cmax)

Part 1 - up to Day 8; Part 2 - up to Day 20

Pharmacokinetics (Tmax)

Part 1 - up to Day 8; Part 2 - up to Day 20

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Study Design & Arms

AllocationRANDOMIZED

MaskingDOUBLE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Single Ascending Dose (Part 1)	EXPERIMENTAL	-
Multiple Ascending Dose (Part 2)	EXPERIMENTAL	-

Interventions

Name	Type	Description
CRN04894 Oral Solution	DRUG	CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.
Placebo Oral Solution	DRUG	Placebo

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Eligibility Criteria

Age Range18 Years — 55 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * Females must be either postmenopausal or surgically sterile; or using stable and permitted highly effective method of contraception - use of oral hormonal contraceptives are not allowed during the study * Male subjects must be surgically sterile or agree to use highly effectiv...

Countries:United States

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