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

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study of TT-00920 in Healthy Subjects

This is a double-blind, randomized, placebo-controlled, multiple ascending 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, 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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yan Yu; Phone Number: 17366389262; Email: yuyan@transtherabio.com
• Study Contact Backup: Name: Ying Chen; Phone Number: 19825055302; Email: chen_ying@transtherabio.com

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pharmaron CPC, Inc.

Participation Criteria

Eligibility Criteria

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

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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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
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
Active Comparator: Dose 2 (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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma drug concentration versus time curve at steady state (AUC0-t, ss and AUC0-τ, ss)	14 days
Maximum observed plasma concentration at steady state (Cmax, ss)	14 days
Time corresponding to occurrence of Cmax,ss at steady state (Tmax, ss)	14 days
Minimum observed plasma concentration at steady state (Cmin, ss)	14 days
Trough plasma concentration (Ctrough)	14 days
Accumulation ratio (Rac)	14 days
Average concentration (Cav)	14 days
Volume of distribution at steady state (Vz/F, ss)	14 days
Clearance at steady state (CL/F, ss)	14 days
Half-life at steady state (T1/2, ss)	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolite characterization in plasma and estimation	observed drug-related material in plasma to determine the presence of any metabolite >10%	14 days
Change in Biomarkers From Baseline to Day 14: cGMP (Pmol/mL)	cGMP: cyclic guanosine monophosphate	14 days
Utilization of PGx results	A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response	14 days

Collaborators and Investigators

• Sponsor: TransThera Sciences (Nanjing), Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TT00920US03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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