Trial | NCT04364789  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    TT-00920 ...

  • Study Participants

    42
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.
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.
Study Started
Feb 05
2020
Primary Completion
Jun 18
2021
Study Completion
Mar 17
2022
Last Update
Feb 27
2023

Drug TT-00920

Tablets

Drug Placebos

Tablets

Pilot dose Cohort Active Comparator

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.

SAD Dose 1 Active Comparator

SAD Dose 2 Active Comparator

SAD Dose 3 Active Comparator

SAD Dose 4 Active Comparator

Food Effect Cohort Active Comparator

Placebo Placebo Comparator

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.
No Results Posted