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

• Status: Active, not recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: TransThera Biosciences Co., Ltd; TransThera Sciences (Nanjing), Inc.

Criteria

Inclusion Criteria:

• Written informed consent must be obtained before any assessment is performed.

• Age ≥ 18 years and ≤ 55 years, male or female of non-childbearing potential (confirmed with follicle stimulating hormone [FSH] test. A bilateral tubal ligation is acceptable as long as there is no fertility potential).

• Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and weighs at least 50 kg.

• No clinically significant findings in medical examination

Exclusion Criteria:

• Any history of clinically serious disease.

• Hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes.

• Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality in clinical test

• Subject with a history of severe visual diseases; or visual changes including flushing lights, blurry vision, color changes, or other visual changes; or abnormal finding with visual tests [color discrimination (Ishihara test) and visual acuity (Snellen chart).

• Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded.