NCT04532957

A Multiple Ascending Dose Study to Investigate Safety of KBP-7072 in Healthy Subjects

A Phase I, Double Blind, Placebo Controlled, Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of KBP-7072 in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: KBP Biosciences · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, placebo-controlled, multiple oral dose study to evaluate safety, tolerability, and pharmacokinetic of KBP-7072 in healthy subjects.

Detailed description

This was a double-blind, randomized, placebo-controlled, parallel-group, multiple oral dose study. Overall, a total of 24 subjects were studied in 3 groups (Groups 1 to 3); with each group consisting of 8 subjects (6 subjects receiving KBP-7072 and 2 subjects receiving placebo). Groups 1 and 2 evaluated 100 and 200 mg QD, respectively. The dose level of 150 mg QD evaluated in Group 3 was determined based on data obtained from Group 2 of this stud

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	KBP-7072	QD oral capsules
DRUG	Placebo	matching placebo capsules

Timeline

• Start date: 2020-08-11
• Primary completion: 2020-10-08
• Completion: 2020-10-15
• First posted: 2020-08-31
• Last updated: 2024-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study