NCT04526496

Safety, Tolerability and Pharmacokinetics of FTP-198 in Healthy Australian Volunteers

A 2-part, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of FTP-198 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human, Phase I, single-dose escalation and multiple-dose escalation clinical trial for FTP-198 conducted in Australian healthy volunteers. The safety, tolerability, and pharmacokinetics of FTP-198 suspension in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	FTP-198, single dose	Single dose of FTP-198, 6 dose levels, oral suspension
DRUG	Placebo, single dose	Placebo matched to FTP-198, oral suspension
DRUG	FTP-198, multiple doses	Multiple doses of FTP-198, 3 dose levels, oral suspension, 7 days
DRUG	Placebo, multiple doses	Placebo matched to FTP-198, oral suspension, 7 days

Timeline

• Start date: 2020-02-24
• Primary completion: 2020-11-05
• Completion: 2020-11-05
• First posted: 2020-08-25
• Last updated: 2021-02-09

Locations

1 site across 1 country: Australia