Status:
COMPLETED
A Phase 1 Study of TT-00920 in Healthy Subjects
Lead Sponsor:
TransThera Sciences (Nanjing), Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 subj...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05355129
Start Date
November 3 2021
End Date
June 6 2022
Last Update
February 27 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 320500