NCT03657030

Study of CVN424 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Doses of CVN424 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Cerevance Beta, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CVN424	SAD / MAD
DRUG	Placebo	Placebo

Timeline

• Start date: 2018-09-18
• Primary completion: 2019-03-01
• Completion: 2019-05-30
• First posted: 2018-09-04
• Last updated: 2019-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study