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

C

Crinetics Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: CRN04894 Oral Solution
Drug: Placebo Oral Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT06048887
CRN04894-01

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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 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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

88 participants in 2 patient groups

Single Ascending Dose (Part 1)
Experimental group
Treatment:
Drug: CRN04894 Oral Solution
Drug: Placebo Oral Solution
Multiple Ascending Dose (Part 2)
Experimental group
Treatment:
Drug: CRN04894 Oral Solution
Drug: Placebo Oral Solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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