Phase I, First-In-Human Study of TT-00920 in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364789
• Other study ID #: TT00920US01
• Status: Completed
• Phase: Phase 1
• Start date: February 5, 2020
• Est. completion date: March 17, 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 first-in-human, randomized, double-blind, placebo-controlled study. The primary objectives of the study were to investigate the safety and tolerability and determine the PK profiles of single ascending doses (SAD) of TT-00920 administered to healthy subjects. The secondary objectives of the study were to assess the effect of food on the PK of TT-00920 following an oral dose.

Description:

There will be 4 single-ascending-dose cohorts and 1 cohort for food effect assessment to assess the safety, tolerability, and PK profile. A pilot dose of 20 mg will be evaluated in 2 subjects (all receiving TT-00920) for safety, tolerability, and PK profile before the initiation of dose escalation.

In single-ascending-dose cohorts, 8 subjects per cohort will be enrolled and randomized to assess the safety, tolerability, and PK profile. In food effect cohort, there will be 8 subjects (all receiving TT-00920). Subjects in food effect cohort will receive 2 single dose periods (Fasted/ Fed) in an open-label, crossover design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 17, 2022
• Est. primary completion date: June 18, 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 before any assessment is performed.

• Age = 18 years and = 55 years, male or female of non-childbearing potential (confirmed with follicle stimulating hormone [FSH] test. A bilateral tubal ligation is acceptable as long as there is no fertility potential).

• Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and weighs at least 50 kg.

• No clinically significant findings in medical examination

Exclusion Criteria:

• Any history of clinically serious disease.

• Hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes.

• Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality in clinical test

• Subject with a history of severe visual diseases; or visual changes including flushing lights, blurry vision, color changes, or other visual changes; or abnormal finding with visual tests [color discrimination (Ishihara test) and visual acuity (Snellen chart).

• 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
Tablets
• Placebos
Tablets

Locations

Country	Name	City	State
United States	Early Phase Clinical Unit Glendale Adventist Medical Center	Los Angeles	California

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 of observed drug-related material in plasma to determine the presence of any metabolite >10%	Exploratory outcome measures	10 days
Other	Cyclic guanosine monophosphate (cGMP) levels in plasma and urine	Exploratory outcome measures	10days
Primary	Numbers of Treatment Emergent Adverse Events(TEAE)	Safety and tolerability of TT-00920	10 days
Primary	Number of participants with Abnormal Laboratory Values	Safety and tolerability of TT-00920	10 days
Primary	Area under the plasma drug concentration versus time curve	PK parameters of TT-00920	10 days
Primary	Maximum Observed Plasma Concentration (Cmax)	PK parameters of TT-00920	10 days
Primary	Time of First Occurrence of Cmax (tmax) Time of first Occurance of Cmax(tmax)	PK parameters of TT-00920	10 days
Primary	Terminal half-life (t1/2)	PK parameters of TT-00920	10 days
Primary	Elimination rate (?z)	PK parameters of TT-00920	10 days
Primary	Volume of distribution (Vz/F)	PK parameters of TT-00920	10 days
Primary	Clearance (CL/F)	PK parameters of TT-00920	10 days
Secondary	Area under the plasma drug concentration versus time curve	the effect of food on the PK of TT-00920 following an oral dose	10 days
Secondary	Maximum Observed Plasma Concentration (Cmax)	the effect of food on the PK of TT-00920 following an oral dose	10 days
Secondary	Time of first Occurance of Cmax(tmax)	the effect of food on the PK of TT-00920 following an oral dose	10 days
Secondary	Terminal half-life (t1/2)	the effect of food on the PK of TT-00920 following an oral dose	10 days
Secondary	Elimination rate (?z)	the effect of food on the PK of TT-00920 following an oral dose	10 days
Secondary	Volume of distribution (Vz/F)	the effect of food on the PK of TT-00920 following an oral dose	10 days
Secondary	Clearance (CL/F)	the effect of food on the PK of TT-00920 following an oral dose	10 days