Study Investigating the Safety, Tolerability, and PK, PD, of CB-0406

NCT04467684 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-06-11

No results posted yet for this study

Summary

The study is designed as a single center, randomized, double-blind, placebo-controlled study to assess the PK, safety, tolerability and PD of CB-0406 in healthy participants. The study will be conducted as a 2-part study.

Conditions

  • Healthy Volunteers

Interventions

DRUG

CB-0406 100 mg

Single oral dose

DRUG

CB-0406 200 mg

Single oral dose

DRUG

CB-0406 400 mg

Single oral dose

DRUG

CB-0406 800 mg

Single oral dose

DRUG

CB-0406 1,000 mg

Single oral dose

DRUG

Matched placebo

Color and size matched placebo

Sponsors & Collaborators

Principal Investigators

  • Elaine Watkins, DO, MSPH · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2021-05-30
Completion
2021-06-06

Countries

  • Australia

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04467684 on ClinicalTrials.gov