Status:
COMPLETED
Phase I, First-In-Human 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 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 singl...
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04364789
Start Date
February 5 2020
End Date
March 17 2022
Last Update
February 27 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Early Phase Clinical Unit Glendale Adventist Medical Center
Los Angeles, California, United States, 91206