NCT04335045

Phase I Study of PH100 (Ecklonia Cava Phlorotannins)

A Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PH100 Capsules in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Phloronol Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to determine the safety and tolerability of PH100, a purified phlorotannins from a brown alga Ecklonia cava and the pharmacokinetics of its major compounds 8,8'-bieckol, dieckol, and phlorofucofuroeckol A (PFF-A), after single, ascending, oral doses of PH100 Capsules (over-encapsulated tablets) in healthy adult volunteers.

Detailed description

This was a single-center, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers in which subjects received either placebo or a 100 mg, 200 mg, 400 mg, 800 mg, 1200 mg, or 1600 mg dose of PH100 capsules (over-encapsulated tablets containing purified Ecklonia cava phlorotannins as an active ingredient) in escalating dose groups (six cohorts). A total of 48 subjects were enrolled. Each cohort comprised eight subjects. Within each cohort, six subjects received PH100 and two subjects received placebo. The first cohort was dosed as a single group with PH100 (100 mg) or placebo. The subsequent five cohorts were dosed sequentially with 200 mg, 400 mg, 800 mg, 1200 mg, and 1600 mg of PH100 or placebo. Safety and pharmacokinetic data were collected and evaluated following each cohort. Dose escalation occurred after review of the safety and pharmacokinetic data from the preceding cohort(s). Doses were administered with subjects in the fasted condition.

Conditions

• Safety Issues

Interventions

Type	Name	Description
DRUG	Placebo	1\~8 Placebo capsule(s) corresponding to each PH100 dose
DRUG	PH100 100mg	1 x 100 mg PH100 oral capsule
DRUG	PH100 200mg	1 x 200 mg PH100 oral capsule
DRUG	PH100 400mg	2 x 200 mg PH100 oral capsules
DRUG	PH100 800mg	4 x 200 mg PH100 oral capsules
DRUG	PH100 1200mg	6 x 200 mg PH100 oral capsules
DRUG	PH100 1600mg	8 x 200 mg PH100 oral capsules

Timeline

• Start date: 2013-09-25
• Primary completion: 2014-12-08
• Completion: 2014-12-08
• First posted: 2020-04-06
• Last updated: 2020-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study