NCT05355129

A Phase 1 Study of TT-00920 in Healthy Subjects

A Phase I, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose and Multiple Dose Study of TT-00920 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: TransThera Sciences (Nanjing), Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects.

Detailed description

This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will comprise of 10 randomized subjects. Subjects received a single dose of TT-00920/ placebo during a single dose period, followed by a 3-10 day washout period, and then entered a 7-day multiple dose period, in which subjects received TT-00920/ placebo three times daily (TID) for days 1-6 and a single dose on day 7. The study will consist of a Screening Period, an In-house Period and a Follow-up.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TT-00920	Tablets
DRUG	TT-00920 Placebo	Tablets

Timeline

• Start date: 2021-11-03
• Primary completion: 2022-06-06
• Completion: 2022-06-06
• First posted: 2022-05-02
• Last updated: 2023-02-27

Locations

1 site across 1 country: China