Phase I, First-In-Human Study of TT-00920 in Healthy Subjects
- Registration Number
- NCT04364789
- Lead Sponsor
- TransThera Sciences (Nanjing), Inc.
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebos - SAD Dose 4 TT-00920 - SAD Dose 3 TT-00920 - Food Effect Cohort TT-00920 - Pilot dose Cohort TT-00920 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. SAD Dose 1 TT-00920 - SAD Dose 2 TT-00920 -
- Primary Outcome Measures
Name Time Method Terminal half-life (t1/2) 10 days PK parameters of TT-00920
Maximum Observed Plasma Concentration (Cmax) 10 days PK parameters of TT-00920
Time of First Occurrence of Cmax （tmax) Time of first Occurance of Cmax（tmax) 10 days PK parameters of TT-00920
Number of participants with Abnormal Laboratory Values 10 days Safety and tolerability of TT-00920
Elimination rate (λz) 10 days PK parameters of TT-00920
Numbers of Treatment Emergent Adverse Events(TEAE) 10 days Safety and tolerability of TT-00920
Area under the plasma drug concentration versus time curve 10 days PK parameters of TT-00920
Clearance (CL/F) 10 days PK parameters of TT-00920
Volume of distribution (Vz/F) 10 days PK parameters of TT-00920
- Secondary Outcome Measures
Name Time Method Terminal half-life (t1/2) 10 days the effect of food on the PK of TT-00920 following an oral dose
Volume of distribution (Vz/F) 10 days the effect of food on the PK of TT-00920 following an oral dose
Elimination rate (λz) 10 days the effect of food on the PK of TT-00920 following an oral dose
Area under the plasma drug concentration versus time curve 10 days the effect of food on the PK of TT-00920 following an oral dose
Time of first Occurance of Cmax（tmax) 10 days the effect of food on the PK of TT-00920 following an oral dose
Clearance (CL/F) 10 days the effect of food on the PK of TT-00920 following an oral dose
Maximum Observed Plasma Concentration (Cmax) 10 days the effect of food on the PK of TT-00920 following an oral dose
Trial Locations
- Locations (1)
Early Phase Clinical Unit Glendale Adventist Medical Center
🇺🇸Los Angeles, California, United States