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

Phase 1

Completed

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

• Registration Number: NCT05043792
• Lead Sponsor: TransThera Sciences (Nanjing), Inc.

Brief Summary

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

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 Timeline

• Study Start: 2021-08-19
• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-14
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1 (Low dose)	TT-00920	TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.
Placebo	TT-00920 Placebo	TT-00920 Placebo, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.
Dose 2 (High dose)	TT-00920	TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clearance at steady state (CL/F, ss)	14 days
Half-life at steady state (T1/2, ss)	14 days
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

Trial Locations

Locations (1)

Pharmaron CPC, Inc.; 🇺🇸 Baltimore, Maryland, United States