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

NCT07745751 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: TRT-448-101
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Safety and Tolerability in Healthy Volunteers

Keywords

Phase 1; TRT-448; Trotana

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of TRT-448 in healthy participants

  Incidence of treatment-emergent adverse events

  Day 1 to Day 28

Secondary Outcomes (4)

• Cmax

  Day 1 to Day 28

• Tmax

  Day 1 to Day 28

• AUClast

  Day 1 to Day 28

• t1/2

  Day 1 to Day 28

Study Arms (2)

TRT-448

EXPERIMENTAL

TRT-448 dosed as oral capsules once (in single ascending dose cohorts) and daily for up to 28 days (in multiple ascending dose cohorts)

Drug: TRT-448

Placebo

PLACEBO COMPARATOR

Placebo dosed as oral capsules once (in single ascending dose cohorts) and once daily for up to 28 days (in multiple ascending dose cohorts)

Drug: Placebo

Interventions

TRT-448 DRUG

Investigational drug modulates immune cells for the treatment of inflammatory disease

TRT-448

Placebo DRUG

Inert placebo utilized as control

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• 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.

Sponsors & Collaborators

• Trotana, Inc.: lead

Central Study Contacts

Clinical Operations

CONTACT

858-926-7304; clinops@trotana.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share