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

NCT04526496 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-02-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sichuan Haisco Pharmaceutical Group Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2020-11-05
Completion
2020-11-05

Countries

  • Australia

Study Locations

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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 NCT04526496 on ClinicalTrials.gov