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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05043792
• Other study ID #: TT00920US03
• Status: Completed
• Phase: Phase 1
• Start date: August 19, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: October 2023
• Source: TransThera Sciences (Nanjing), Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• TT-00920
TT-00920 Tablets
• TT-00920 Placebo
TT-00920 Placebo Tablets

Locations

Country	Name	City	State
United States	Pharmaron CPC, Inc.	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
TransThera Sciences (Nanjing), Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolite characterization in plasma and estimation	observed drug-related material in plasma to determine the presence of any metabolite >10%	14 days
Other	Change in Biomarkers From Baseline to Day 14: cGMP (Pmol/mL)	cGMP: cyclic guanosine monophosphate	14 days
Other	Utilization of PGx results	A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response	14 days
Primary	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	Area under the plasma drug concentration versus time curve at steady state (AUC0-t, ss and AUC0-t, ss)		14 days
Secondary	Maximum observed plasma concentration at steady state (Cmax, ss)		14 days
Secondary	Time corresponding to occurrence of Cmax,ss at steady state (Tmax, ss)		14 days
Secondary	Minimum observed plasma concentration at steady state (Cmin, ss)		14 days
Secondary	Trough plasma concentration (Ctrough)		14 days
Secondary	Accumulation ratio (Rac)		14 days
Secondary	Average concentration (Cav)		14 days
Secondary	Volume of distribution at steady state (Vz/F, ss)		14 days
Secondary	Clearance at steady state (CL/F, ss)		14 days
Secondary	Half-life at steady state (T1/2, ss)		14 days