Healthy
Conditions
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.
Interventions
DRUGTT-00920
Tablets
DRUGPlacebos
Tablets
Sponsors
TransThera Sciences (Nanjing), Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Paticipant, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance (CL/F) | 10 days | PK parameters of TT-00920 |
| Numbers of Treatment Emergent Adverse Events(TEAE) | 10 days | Safety and tolerability of TT-00920 |
| Number of participants with Abnormal Laboratory Values | 10 days | Safety and tolerability of TT-00920 |
| Area under the plasma drug concentration versus time curve | 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 |
| Terminal half-life (t1/2) | 10 days | PK parameters of TT-00920 |
| Elimination rate (λz) | 10 days | PK parameters of TT-00920 |
| Volume of distribution (Vz/F) | 10 days | PK parameters of TT-00920 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clearance (CL/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 |
| Volume of distribution (Vz/F) | 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 |
| Maximum Observed Plasma Concentration (Cmax) | 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 |
| Terminal half-life (t1/2) | 10 days | the effect of food on the PK of TT-00920 following an oral dose |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cyclic guanosine monophosphate (cGMP) levels in plasma and urine | 10days | Exploratory outcome measures |
| Metabolite characterization in plasma and estimation of observed drug-related material in plasma to determine the presence of any metabolite >10% | 10 days | Exploratory outcome measures |
Countries
United States
Outcome results
None listed