Study of CVN424 in Healthy Subjects

Cerevance

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CVN424; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03657030

CVN424-101

Details and patient eligibility

About

This is a phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose ascending study in healthy subjects.

Full description

Part 1: Single-Dose Regimen and Fasted-Fed Crossover - For the single-dose regimen, approximately 40 healthy male and female subjects will be enrolled in 1 of 5 single dose cohorts (designated as S1 through S5, respectively) in an ascending fashion.

Part 2: Multiple-Dose Regimen

• For the multiple-dose regimen, approximately 24 healthy male and female subjects age 18 to 50 years old will be enrolled in 1 of the 3 multiple-dose cohorts (designated as M1 through M3, respectively) in an ascending fashion.

Enrollment: 64 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements.
• The subject signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.
• Subject is a healthy male or female adult who is 18 to 50 years of age inclusive at the time of ICF and study drug dosing.
• Subject weighs at least 45 kg (99 lbs) and has a BMI between 18.0 and 30.0 kg/m2, inclusive at Screening.
• A male subject who is nonsterilized and sexually active with a female partner of childbearing potential* agrees to use adequate contraception* from signing of the ICF throughout the duration of the study and for 12 weeks after last dose.
• A female subject with no childbearing potential, defined as the subject has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years and FSH>40 IU/L).

Exclusion criteria

• Subjects have a known hypersensitivity to any component of the formulation of CVN424.
• Subjects have evidence of CS neurologic, cardiovascular, pulmonary, hepatic, hematopoietic disease, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, serious allergy, allergic skin rash, psychiatric disorder, or other abnormality that may impact the ability of the subject to participate or potentially confound the study results.
• There is any finding in the subject's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a condition that might interfere with the conduct or interpretation of the study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

Single Ascending Dose

Active Comparator group

Description:

The planned dose levels will be 1, 5, 25, 75, and 225 mg CVN424 and matching placebo.

Treatment:

Drug: Placebo

Drug: CVN424

Multiple Ascending Dose

Active Comparator group

Description:

The planned dose levels will be 25, 75, and 150 mg CVN424 and matching placebo.

Treatment:

Drug: Placebo

Drug: CVN424