CRN01941 - Healthy Volunteers | Phase 1 | Crinetics Pharmaceuticals, Inc. | BiopharmaWatch

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CRN01941

Phase 1

Healthy Volunteers | Small molecule | Other |Crinetics Pharmaceuticals, Inc.|Last Updated: Nov 4, 2020

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-BlindPLACEBO_CONTROLLED

Total Trials1

Total Enrollment57

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT03936166	A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult Volunteers	PHASE1	COMPLETED	57	—	—	Apr 29, 2019	Dec 16, 2019	Nov 4, 2020	1	Australia

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Study Endpoints

Primary Endpoints

Number of participants with treatment emergent adverse events by severity

Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8

Number of participants with serious adverse events (SAEs)

Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8

Number of participants with clinically significant changes in vital signs

Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8

Number of participants with ECG abnormalities

Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8

Number of participants with clinical laboratory abnormalities

Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8

Secondary Endpoints

Pharmacokinetics (AUC)

Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8

Pharmacokinetics (Cmax)

Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8

Pharmacokinetics (Tmax)

Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8

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Study Design & Arms

AllocationRANDOMIZED

MaskingQUADRUPLE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Single Ascending Dose (Part 1)	EXPERIMENTAL	-
Multiple Ascending Dose (Part 2)	EXPERIMENTAL	-
Elderly Cohort (Part 3)	PLACEBO_COMPARATOR	-

Interventions

Name	Type	Description
CRN01941 Oral Solution	DRUG	Investigational drug
CRN01941 Oral Capsule	DRUG	Investigational drug
Placebo Oral Solution	DRUG	Placebo
Placebo Oral Capsule	DRUG	Placebo

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Eligibility Criteria

Age Range18 Years — 85 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: 1. Male and female subjects 18 to 55 years of age, inclusive, at time of screening (Parts 1 and 2 only). 2. Males and females subjects 65 to 85 years of age at screening (Part 3 only). 3. Females must be non-pregnant and non-lactating, postmenopausal by history and confirmed by ...

Countries:Australia

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