Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TRT-448 in Healthy Adult Subjects
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorTrotana, Inc.
About this trial
Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TRT-448 in Healthy Adult Subjects
Eligibility criteria
Qualifiers
Medically healthy , as determined by pre-study medical history, and without clinically significant abnormalities
Adult males and females, 18 to 55 years of age (inclusive) at screening
Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) with body weight: ≥ 70 kg for the SAD 1 cohort; ≥ 50 kg for all other cohorts
Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions
Disqualifiers
History of anaphylaxis or other significant allergy which would interfere with the volunteer's ability to participate in the study, including severe Types I-IV hypersensitivity reactions, cytokine release syndrome, or allergic reactions to multiple drugs
History or presence of cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal cholecystectomy, irritable bowel syndrome, inflammatory bowel disease, etc.), esophageal, endocrine, immunologic, autoimmune and/or inflammatory disease, dermatologic, psychiatric, or neurological disease/disorder
History of surgery or hospitalization within 3 months prior to screening, or surgery planned during the study.
Any history of malignant disease in the last 10 years, including leukemia, lymphoma or any significant hematology/oncology disease.
Trial design
Treatments tested in this trial
- TRT-448
- Placebo
Treatment groups
144 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov