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CRN01941

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED

Total Trials1

Total Enrollment57

FDA Designations

No designations recorded

Clinical trial landscape

CRN01941 · 1 trial · 1 indication

Phase 1 1

NCT03936166A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult VolunteersHealthy Volunteers

COMPLETED57 Analytics

PHASE1COMPLETED

A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult Volunteers

Healthy Volunteers

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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 to 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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Frequently asked questions about CRN01941

What is CRN01941 used for?

CRN01941 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease or condition. The drug is in Phase 1 clinical development, with a completed study evaluating its safety, tolerability, and pharmacokinetics in healthy adult participants.

Who makes CRN01941?

CRN01941 is being developed by Crinetics Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker CRNX. The company is conducting clinical research on this investigational small molecule in healthy volunteers.

What phase is CRN01941 in?

CRN01941 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still in the early stages of clinical testing.

What clinical trials is CRN01941 in?

CRN01941 has one completed Phase 1 clinical trial, NCT03936166, titled 'A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult Volunteers.' The study enrolled 57 participants in Australia and was randomized, double-blind, and placebo-controlled.

Is CRN01941 FDA approved?

CRN01941 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial in healthy volunteers was designed to assess safety and tolerability, but the drug has not yet been evaluated for any therapeutic indication.