Clinical trial NCT05355129: A Phase 1 Study of TT-00920 in Healthy Subjects
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose and Multiple 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: 2022-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects.

Detailed description: This is a double-blind, randomized, placebo-controlled, ascending single dose and multiple dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will comprise of 10 randomized subjects. Subjects received a single dose of TT-00920/ placebo during a single dose period, followed by a 3-10 day washout period, and then entered a 7-day multiple dose period, in which subjects received TT-00920/ placebo three times daily (TID) for days 1-6 and a single dose on day 7. 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 male weighs at least 50.0 kg and female weighs at least 45.0 kg

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
* Subject with a history of severe visual diseases; or visual changes
* Subject is unable to complete this study for other reasons

Primary outcomes:
measure: Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) as assessed by Investigator
timeFrame: 20 days
measure: Percentage of Participants With Clinically relevant changes in vital signs
timeFrame: 20 days
measure: Percentage of Participants With Clinically relevant changes in clinical laboratory tests
timeFrame: 20 days
measure: Percentage of Participants With Clinically relevant changes in Electrocardiogram (ECG)
timeFrame: 20 days
Secondary outcomes:
measure: Derived multiple dose PK parameters
timeFrame: 20 days
measure: Derived multiple dose PK parameters
timeFrame: 20 days
measure: Derived multiple dose PK parameters
timeFrame: 20 days
measure: Derived multiple dose PK parameters
timeFrame: 20 days
measure: Derived multiple dose PK parameters
timeFrame: 20 days
measure: Derived multiple dose PK parameters
timeFrame: 20 days
measure: Derived single dose PK parameters
timeFrame: 20 days
measure: Derived single dose PK parameters
timeFrame: 20 days
measure: Derived single dose PK parameters
timeFrame: 20 days
Other outcomes:
measure: TT-00920 metabolites as compared to baseline
timeFrame: 20 days
measure: Change in Biomarkers From Baseline to Day 7: cGMP (Pmol/mL)
timeFrame: 20 days
measure: Percentage of Subjects With an Actionable Genotype, Defined as the Presence of Any Mutation(s) That is (Are) Used to Guide a Drug/Dose Modification
timeFrame: 20 days
measure: Urine PK parameters
timeFrame: 20 days
measure: Urine PK parameters Feurine%
timeFrame: 20 days
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: