NCT04364789

Phase I, First-In-Human Study of TT-00920 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: TransThera Sciences (Nanjing), Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human, randomized, double-blind, placebo-controlled study. The primary objectives of the study were to investigate the safety and tolerability and determine the PK profiles of single ascending doses (SAD) of TT-00920 administered to healthy subjects. The secondary objectives of the study were to assess the effect of food on the PK of TT-00920 following an oral dose.

Detailed description

There will be 4 single-ascending-dose cohorts and 1 cohort for food effect assessment to assess the safety, tolerability, and PK profile. A pilot dose of 20 mg will be evaluated in 2 subjects (all receiving TT-00920) for safety, tolerability, and PK profile before the initiation of dose escalation. In single-ascending-dose cohorts, 8 subjects per cohort will be enrolled and randomized to assess the safety, tolerability, and PK profile. In food effect cohort, there will be 8 subjects (all receiving TT-00920). Subjects in food effect cohort will receive 2 single dose periods (Fasted/ Fed) in an open-label, crossover design.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TT-00920	Tablets
DRUG	Placebos	Tablets

Timeline

• Start date: 2020-02-05
• Primary completion: 2021-06-18
• Completion: 2022-03-17
• First posted: 2020-04-28
• Last updated: 2023-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study