A Phase 1 Study of TT-00920 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TT-00920; Drug: TT-00920 Placebo

• Registration Number: NCT05355129
• Lead Sponsor: TransThera Sciences (Nanjing), Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2021-11-03
• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-05-02
• Primary Completion: 2022-06-06
• Study Completion: 2022-06-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose 1	TT-00920	low dose
Dose 2	TT-00920	Middle dose
Dose 3	TT-00920	High dose
Placebo	TT-00920 Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) as assessed by Investigator	20 days	An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.
Percentage of Participants With Clinically relevant changes in vital signs	20 days	Vital signs include temperature, respiratory rate, blood pressure and pulse
Percentage of Participants With Clinically relevant changes in clinical laboratory tests	20 days	Safety laboratory tests includes hematology, coagulation, serum chemistries, and urinalysis.
Percentage of Participants With Clinically relevant changes in Electrocardiogram (ECG)	20 days	A standard 12-lead ECG was performed.

Secondary Outcome Measures

Name	Time	Method
Derived single dose PK parameters	20 days	tmax
Derived multiple dose PK parameters	20 days	CL/F, ss

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China