A Phase 1 Study of TT-00920 in Healthy Subjects

A Phase I, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose and Multiple Dose Study of TT-00920 in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: TT-00920; Drug: TT-00920 Placebo

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 320500
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: TT-00920 Placebo; Tablets
Experimental: Dose 1; low dose	Drug: TT-00920; Tablets
Experimental: Dose 2; Middle dose	Drug: TT-00920; Tablets
Experimental: Dose 3; High dose	Drug: TT-00920; Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) as assessed by Investigator	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.	20 days
Percentage of Participants With Clinically relevant changes in vital signs	Vital signs include temperature, respiratory rate, blood pressure and pulse	20 days
Percentage of Participants With Clinically relevant changes in clinical laboratory tests	Safety laboratory tests includes hematology, coagulation, serum chemistries, and urinalysis.	20 days
Percentage of Participants With Clinically relevant changes in Electrocardiogram (ECG)	A standard 12-lead ECG was performed.	20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Derived multiple dose PK parameters	AUC0 t, ss	20 days
Derived multiple dose PK parameters	Cmax, ss	20 days
Derived multiple dose PK parameters	tmax, ss	20 days
Derived multiple dose PK parameters	Rac	20 days
Derived multiple dose PK parameters	Cav	20 days
Derived multiple dose PK parameters	CL/F, ss	20 days
Derived single dose PK parameters	AUC0 t	20 days
Derived single dose PK parameters	Cmax	20 days
Derived single dose PK parameters	tmax	20 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
TT-00920 metabolites as compared to baseline	AUC of observed drug-related material in plasma to determine the presence of any metabolite >10%	20 days
Change in Biomarkers From Baseline to Day 7: cGMP (Pmol/mL)	cGMP: cyclic guanosine monophosphate	20 days
Percentage of Subjects With an Actionable Genotype, Defined as the Presence of Any Mutation(s) That is (Are) Used to Guide a Drug/Dose Modification	An actionable genotype is defined as the presence of at least one mutation that is used to guide a drug/dose modification	20 days
Urine PK parameters	Aet	20 days
Urine PK parameters Feurine%	Feurine%: Fraction of drug excreted in urine	20 days

Collaborators and Investigators

• Sponsor: TransThera Sciences (Nanjing), Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): June 6, 2022
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TT00920CN02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No