A Phase 1 Study of TT-00920 in Healthy Subjects

Healthy Clinical Trial

Official title:

A Phase I, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose and Multiple Dose Study of TT-00920 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05355129
• Other study ID #: TT00920CN02
• Status: Completed
• Phase: Phase 1
• Start date: November 3, 2021
• Est. completion date: June 6, 2022

Study information

• Verified date: February 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, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 6, 2022
• Est. primary completion date: June 6, 2022
• 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 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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
TransThera Sciences (Nanjing), Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TT-00920 metabolites as compared to baseline	AUC of observed drug-related material in plasma to determine the presence of any metabolite >10%	20 days
Other	Change in Biomarkers From Baseline to Day 7: cGMP (Pmol/mL)	cGMP: cyclic guanosine monophosphate	20 days
Other	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	An actionable genotype is defined as the presence of at least one mutation that is used to guide a drug/dose modification	20 days
Other	Urine PK parameters	Aet	20 days
Other	Urine PK parameters Feurine%	Feurine%: Fraction of drug excreted in urine	20 days
Primary	Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) as assessed by Investigator	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.	20 days
Primary	Percentage of Participants With Clinically relevant changes in vital signs	Vital signs include temperature, respiratory rate, blood pressure and pulse	20 days
Primary	Percentage of Participants With Clinically relevant changes in clinical laboratory tests	Safety laboratory tests includes hematology, coagulation, serum chemistries, and urinalysis.	20 days
Primary	Percentage of Participants With Clinically relevant changes in Electrocardiogram (ECG)	A standard 12-lead ECG was performed.	20 days
Secondary	Derived multiple dose PK parameters	AUC0 t, ss	20 days
Secondary	Derived multiple dose PK parameters	Cmax, ss	20 days
Secondary	Derived multiple dose PK parameters	tmax, ss	20 days
Secondary	Derived multiple dose PK parameters	Rac	20 days
Secondary	Derived multiple dose PK parameters	Cav	20 days
Secondary	Derived multiple dose PK parameters	CL/F, ss	20 days
Secondary	Derived single dose PK parameters	AUC0 t	20 days
Secondary	Derived single dose PK parameters	Cmax	20 days
Secondary	Derived single dose PK parameters	tmax	20 days