Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TRT-448 in Healthy Adult Subjects

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Safety and Tolerability in Healthy Volunteers

In brief

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

Key facts

Study ID

NCT07745751

Run by

Trotana, Inc.

People needed

144

Starts

2026-08-30

Expected to finish

2027-05-30

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Note: Participants with curatively resected non-melanoma skin cancers >2 years prior to screening or curatively excised cervical carcinoma in situ > 5 years prior to screening are not excluded.
• Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
• History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death or screening QTcF > 450 msec in males or > 470 msec in female) or a known arrhythmia (Note: asymptomatic first-degree heart block is not exclusionary).
• Presence or having sequelae of gastrointestinal, liver (including Gilbert's syndrome), kidney, gallbladder, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Liver function test results elevated more than 1.3-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT).
• Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73m2 using the 2021 CKD-EPI creatinine equation.
• Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.

Full record on ClinicalTrials.gov

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