A Phase 1 Study of TT-00920 in Healthy Subjects

• Sponsor: TransThera Sciences (Nanjing), Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05355129
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 7.9
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: TT-00920; Drug: TT-00920 Placebo	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase I, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose and Multiple Dose Study of TT-00920 in Healthy Subjects
• Actual Study Start Date: Nov 3, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo	Drug: TT-00920 Placebo; Tablets

Outcome Measures

Primary Outcome Measures

1. 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.

2. Percentage of Participants With Clinically relevant changes in vital signs [20 days]

   Vital signs include temperature, respiratory rate, blood pressure and pulse

3. Percentage of Participants With Clinically relevant changes in clinical laboratory tests [20 days]

   Safety laboratory tests includes hematology, coagulation, serum chemistries, and urinalysis.

4. Percentage of Participants With Clinically relevant changes in Electrocardiogram (ECG) [20 days]

   A standard 12-lead ECG was performed.

Secondary Outcome Measures

1. Derived multiple dose PK parameters [20 days]

   AUC0 t, ss

2. Derived multiple dose PK parameters [20 days]

   Cmax, ss

3. Derived multiple dose PK parameters [20 days]

   tmax, ss

4. Derived multiple dose PK parameters [20 days]

   Rac

5. Derived multiple dose PK parameters [20 days]

   Cav

6. Derived multiple dose PK parameters [20 days]

   CL/F, ss

7. Derived single dose PK parameters [20 days]

   AUC0 t

8. Derived single dose PK parameters [20 days]

   Cmax

9. Derived single dose PK parameters [20 days]

   tmax

Other Outcome Measures

1. TT-00920 metabolites as compared to baseline [20 days]

   AUC of observed drug-related material in plasma to determine the presence of any metabolite >10%

2. Change in Biomarkers From Baseline to Day 7: cGMP (Pmol/mL) [20 days]

   cGMP: cyclic guanosine monophosphate

3. 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 [20 days]

   An actionable genotype is defined as the presence of at least one mutation that is used to guide a drug/dose modification

4. Urine PK parameters [20 days]

   Aet

5. Urine PK parameters Feurine% [20 days]

   Feurine%: Fraction of drug excreted in urine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hispital of Soochow University	Suzhou	Jiangsu	China	320500

Sponsors and Collaborators

• TransThera Sciences (Nanjing), Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TransThera Sciences (Nanjing), Inc.
• ClinicalTrials.gov Identifier: NCT05355129
• Other Study ID Numbers: TT00920CN02
• First Posted: May 2, 2022
• Last Update Posted: May 2, 2022
• Last Verified: Apr 1, 2022

• 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

Study Results

No Results Posted as of May 2, 2022