NCT04467684

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

A Phase 1, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study Investigating the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of CB-0406 Tablets in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study is designed as a 2-part study: Part 1 is designed as single ascending dose (SAD) escalation study investigating 5 dose levels. Each cohort will consist of participants (N=8) to be randomly assigned to receive a blinded oral dose of CB-0406 (n=6) or placebo (n=2). Dose levels of CB-0406 in the sequential cohorts will be 100 mg, 200 mg, 400 mg, 800 mg or 1000 mg to be administered once on each cohorts study Day 1. Part 2 is designed as multiple ascending dose (MAD) escalation study investigating up to 5 dose levels as determined by the SAD cohort. Doses will be determined following completion and review of the safety and PK findings for Cohorts 1 to Cohort 5 in Part 1.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-07
• Primary completion: 2021-05-30
• Completion: 2021-06-06
• First posted: 2020-07-13
• Last updated: 2021-06-11

Locations

1 site across 1 country: Australia