Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dose 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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-19

Study Completion Date

2021-11-30

Brief Summary

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

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Detailed Description

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This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will be comprised of 10 randomized subjects dosed three times daily for 13 days and one time for 1 day. The study will consist of a Screening Period, an In-house Period and a Follow-up.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dose 1 (Low dose)

TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.

Group Type ACTIVE_COMPARATOR

TT-00920

Intervention Type DRUG

TT-00920 Tablets

Dose 2 (High dose)

TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.

Group Type ACTIVE_COMPARATOR

TT-00920

Intervention Type DRUG

TT-00920 Tablets

Placebo

TT-00920 Placebo, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.

Group Type PLACEBO_COMPARATOR

TT-00920 Placebo

Intervention Type DRUG

TT-00920 Placebo Tablets

Interventions

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TT-00920

TT-00920 Tablets

Intervention Type DRUG

TT-00920 Placebo

TT-00920 Placebo Tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent must be obtained
* Age ≥ 18.0 years and ≤ 55.0 years, male or female
* BMI between 18.0 and 30.0 kg/m2, inclusive, and weighs at least 50.0 kg
* No clinically significant findings in medical examination

Exclusion Criteria

* Known hypersensitivity or allergy to lactose
* Vaccination with any live vaccine, or vaccination employing an mRNA platform within 28 days and/or vaccination with any inactivated vaccine within 7 days of study drug administration
* Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality
* HbA1c \> 5.7 % at Screening
* Subject with a history of severe visual diseases; or visual changes
* 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