Clinical trial NCT05043792: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dose of TT-00920 in Healthy Subjects
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study of TT-00920 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: TransThera Sciences (Nanjing), Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability]
timeFrame: 14 days
Secondary outcomes:
measure: Area under the plasma drug concentration versus time curve at steady state (AUC0-t, ss and AUC0-τ, ss)
timeFrame: 14 days
measure: Maximum observed plasma concentration at steady state (Cmax, ss)
timeFrame: 14 days
measure: Time corresponding to occurrence of Cmax,ss at steady state (Tmax, ss)
timeFrame: 14 days
measure: Minimum observed plasma concentration at steady state (Cmin, ss)
timeFrame: 14 days
measure: Trough plasma concentration (Ctrough)
timeFrame: 14 days
measure: Accumulation ratio (Rac)
timeFrame: 14 days
measure: Average concentration (Cav)
timeFrame: 14 days
measure: Volume of distribution at steady state (Vz/F, ss)
timeFrame: 14 days
measure: Clearance at steady state (CL/F, ss)
timeFrame: 14 days
measure: Half-life at steady state (T1/2, ss)
timeFrame: 14 days
Other outcomes:
measure: Metabolite characterization in plasma and estimation
timeFrame: 14 days
measure: Change in Biomarkers From Baseline to Day 14: cGMP (Pmol/mL)
timeFrame: 14 days
measure: Utilization of PGx results
timeFrame: 14 days
Locations:
city: Baltimore
country: United States
facility: Pharmaron CPC, Inc.
state: Maryland
Study officials:
References: