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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-05

Study Completion Date

2022-03-17

Brief Summary

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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.

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double (Paticipant, Investigator)

Study Groups

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Pilot dose Cohort

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.

Group Type ACTIVE_COMPARATOR

TT-00920

Intervention Type DRUG

Tablets

SAD Dose 1

Group Type ACTIVE_COMPARATOR

TT-00920

Intervention Type DRUG

Tablets

SAD Dose 2

Group Type ACTIVE_COMPARATOR

TT-00920

Intervention Type DRUG

Tablets

SAD Dose 3

Group Type ACTIVE_COMPARATOR

TT-00920

Intervention Type DRUG

Tablets

SAD Dose 4

Group Type ACTIVE_COMPARATOR

TT-00920

Intervention Type DRUG

Tablets

Food Effect Cohort

Group Type ACTIVE_COMPARATOR

TT-00920

Intervention Type DRUG

Tablets

Placebo

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Tablets

Interventions

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TT-00920

Tablets

Intervention Type DRUG

Placebos

Tablets

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes