A Phase 1 Study of TT-00920 in Healthy Subjects

NCT ID: NCT05355129

Last Updated: 2023-02-27

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-03

Study Completion Date

2022-06-06

Brief Summary

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

Detailed Description

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This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will comprise of 10 randomized subjects. Subjects received a single dose of TT-00920/ placebo during a single dose period, followed by a 3-10 day washout period, and then entered a 7-day multiple dose period, in which subjects received TT-00920/ placebo three times daily (TID) for days 1-6 and a single dose on day 7. 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

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dose 1

low dose

Group Type EXPERIMENTAL

TT-00920

Intervention Type DRUG

Tablets

Dose 2

Middle dose

Group Type EXPERIMENTAL

TT-00920

Intervention Type DRUG

Tablets

Dose 3

High dose

Group Type EXPERIMENTAL

TT-00920

Intervention Type DRUG

Tablets

Placebo

Group Type PLACEBO_COMPARATOR

TT-00920 Placebo

Intervention Type DRUG

Tablets

Interventions

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TT-00920

Tablets

Intervention Type DRUG

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 male weighs at least 50.0 kg and female weighs at least 45.0 kg

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
* Subject with a history of severe visual diseases; or visual changes
* Subject is unable to complete this study for other reasons
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TransThera Sciences (Nanjing), Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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TT00920CN02

Identifier Type: -

Identifier Source: org_study_id

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