Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers

NCT06048887 | Completed Phase 1 FDA Drug

• 1 other identifier: CRN04894-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety of CRN04894 in healthy volunteers as well as the relationship between exposure and pharmacodynamic (PD) parameters.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

• Pharmacokinetics (T1/2)

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

Other Outcomes (2)

• Change in ACTH-stimulated serum cortisol

  Part 1 - Day 1; Part 2 - Day 10

• Change in serum cortisol

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

Study Arms (2)

Single Ascending Dose (Part 1)

EXPERIMENTAL

Drug: CRN04894 Oral Solution; Drug: Placebo Oral Solution

Multiple Ascending Dose (Part 2)

EXPERIMENTAL

Drug: CRN04894 Oral Solution; Drug: Placebo Oral Solution

Interventions

CRN04894 Oral Solution DRUG

CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.

Multiple Ascending Dose (Part 2); Single Ascending Dose (Part 1)

Placebo Oral Solution DRUG

Placebo

Multiple Ascending Dose (Part 2); Single Ascending Dose (Part 1)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 effective form of contraception when sexually active with a female partner of child bearing potential
• ACTH-stimulated serum cortisol high-dose ACTH stimulation test conducted at Screening

You may not qualify if:

• Use of topical, nasal, inhaled, or oral corticosteroids.
• Use of any investigational drug within the past 60 days.
• Have a medically significant illness within 30 days prior to screening.
• Use of prohibited prescribed or nonprescribed medications and/or nonmedications/alternative medicinal products.
• Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
• Unstable psychological disorder ≤1 year prior to Screening.

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (1)

QPS-Miami Research Associates

Miami, Florida, 33143, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 21, 2023
• Study Start: December 18, 2020
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

US (1)