Study of CVN424 in Healthy Subjects

Cerevance Beta, Inc.64 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

CVN424DRUG

SAD / MAD

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PPD Development, LP

Austin, Texas, United States

Outcomes

Primary Outcomes

Evaluation of adverse events

Occurrence of all adverse events from signing of informed consent through end of study treatment.

Time frame: Baseline through 14 days post-dose

Evaluation of Hematology

RBC

Time frame: Baseline through 14 days post-dose

Evaluation of Vital Signs

Oral Temperature (°C )

Time frame: Baseline through 14 days post-dose

Evaluation of Electrocardiograms

Standard 12-lead ECG - QT interval

Time frame: Baseline through 14 days post-dose

Evaluation of BMI

Weight and Height will be combined to calculate BMI using the following formula: BMI = weight (kg)/\[height (m)\]2

Time frame: Baseline through 14 days post-dose

Evaluation of Serum Chemistry

ALT

Time frame: Baseline through 14 days post-dose

Evaluation of Urinalysis

Time frame: Baseline through 14 days post-dose

Evaluation of Vital Signs

Respiration rate

Time frame: Baseline through 14 days post-dose

Evaluation of Vital Signs

Pulse rate

Time frame: Baseline through 14 days post-dose

Data from ClinicalTrials.gov

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Secondary Outcomes

Plasma Concentration (AUC) of CVN424

To evaluate the pharmacokinetics of single and multiple doses of CVN424. Pharmacokinetic parameters including, but not limited to area under the plasma concentration-time curve (AUC) from 0 to 24hours (AUC0-24)

Time frame: SAD: PK Collection on Day 1-4, and early termination (up to 8 days); MAD: PK Collection on Day 1-10, and early termination (up to 14 days)

Plasma Concentration (Cmax) of CVN424

To evaluate the pharmacokinetics of single and multiple doses of CVN424. Pharmacokinetic parameters including, but not limited to maximum plasma concentration (Cmax).

Time frame: SAD: PK Collection on Day 1-4, and early termination (up to 8 days); MAD: PK Collection on Day 1-10, and early termination (up to 14 days)

Food effect by measurement of plasma PK (Cmax)

Assess the effect of food on the bioavailability in the current formulation after digesting a high caloric meal.

Time frame: Baseline through 14 days post-dose

Food effect by measurement of plasma PK (AUC)

Assess the effect of food on the bioavailability in the current formulation after digesting a high caloric meal.

Time frame: Baseline through 14 days post-dose