Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dose of TT-00920 in Healthy Subjects

• Sponsor: TransThera Sciences (Nanjing), Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05043792
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 5.3
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

This is a double-blind, randomized, placebo-controlled, multiple ascending 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, 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study of TT-00920 in Healthy Subjects
• Actual Study Start Date: Sep 20, 2021
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dose 1 (Low dose) TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.	Drug: TT-00920; TT-00920 Tablets
Active Comparator: Dose 2 (Middle dose) TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.	Drug: TT-00920; TT-00920 Tablets
Active Comparator: Dose 3 (High dose) TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.	Drug: TT-00920; TT-00920 Tablets
Placebo Comparator: Placebo TT-00920 Placebo, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.	Drug: TT-00920 Placebo; TT-00920 Placebo Tablets

Outcome Measures

Primary Outcome Measures

1. Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability] [14 days]

   TEAE: Treatment emergent adverse events Safety parameters: physical examinations, vital signs, clinical laboratory tests , 12-lead ECG in triplicate, cardiac Holter monitoring, visual tests and ophthalmological examinations

Secondary Outcome Measures

1. Area under the plasma drug concentration versus time curve at steady state (AUC0-t, ss and AUC0-τ, ss) [14 days]

2. Maximum observed plasma concentration at steady state (Cmax, ss) [14 days]

3. Time corresponding to occurrence of Cmax,ss at steady state (Tmax, ss) [14 days]

4. Minimum observed plasma concentration at steady state (Cmin, ss) [14 days]

5. Trough plasma concentration (Ctrough) [14 days]

6. Accumulation ratio (Rac) [14 days]

7. Average concentration (Cav) [14 days]

8. Volume of distribution at steady state (Vz/F, ss) [14 days]

9. Clearance at steady state (CL/F, ss) [14 days]

10. Half-life at steady state (T1/2, ss) [14 days]

Other Outcome Measures

1. Metabolite characterization in plasma and estimation [14 days]

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

2. Change in Biomarkers From Baseline to Day 14: cGMP (Pmol/mL) [14 days]

   cGMP: cyclic guanosine monophosphate

3. Utilization of PGx results [14 days]

   A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pharmaron CPC, Inc.	Baltimore	Maryland	United States	21201

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: NCT05043792
• Other Study ID Numbers: TT00920US03
• First Posted: Sep 14, 2021
• Last Update Posted: Nov 3, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• 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 Nov 3, 2021