A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study of TT-00920 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- TT-00920
- Conditions
- Healthy
- Sponsor
- TransThera Sciences (Nanjing), Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability]
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects.
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Dose 1 (Low dose)
TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.
Intervention: TT-00920
Dose 2 (High dose)
TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.
Intervention: TT-00920
Placebo
TT-00920 Placebo, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14.
Intervention: TT-00920 Placebo
Outcomes
Primary Outcomes
Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability]
Time Frame: 14 days
* 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
Secondary Outcomes
- Clearance at steady state (CL/F, ss)(14 days)
- Half-life at steady state (T1/2, ss)(14 days)
- Maximum observed plasma concentration at steady state (Cmax, ss)(14 days)
- Area under the plasma drug concentration versus time curve at steady state (AUC0-t, ss and AUC0-τ, ss)(14 days)
- Time corresponding to occurrence of Cmax,ss at steady state (Tmax, ss)(14 days)
- Minimum observed plasma concentration at steady state (Cmin, ss)(14 days)
- Trough plasma concentration (Ctrough)(14 days)
- Accumulation ratio (Rac)(14 days)
- Average concentration (Cav)(14 days)
- Volume of distribution at steady state (Vz/F, ss)(14 days)