Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TRT-448 in Healthy Adult Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TRT-448, Placebo.
- Who it may be relevant to
- Registry conditions: Safety and Tolerability in Healthy Volunteers. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A 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
Overview
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
Detailed description
This is a randomized, double-blind, placebo-controlled first-in-human (FIH) study of TRT-448 conducted in healthy adult participants. Key safety and tolerability assessments of TRT-448 will be regularly reviewed by an appointed Safety Review Committee (SRC). The study will be conducted in 2 parts: single ascending dose (SAD) and multiple ascending dose (MAD) healthy adult subject cohorts. Eligible subjects will be enrolled into a SAD cohort and will be randomized to receive a single dose of TRT-448 or placebo in a 3:1 ratio, respectively, via oral administration. Eligible participants will be enrolled into MAD cohorts and randomized to receive TRT-448 or placebo in a 3:1 ratio, respectively, once daily (QD) via oral administration from Day 1 and through Day 14 (MAD escalation cohorts) or from Day 1 through Day 28 (MAD expansion cohorts), inclusive. A total of up to 144 participants are planned to be enrolled. Each subject will be assessed for safety, pharmacokinetics and pharmacodynamics of TRT-448.
Interventions
- Drug TRT-448
Investigational drug modulates immune cells for the treatment of inflammatory disease - Drug Placebo
Inert placebo utilized as control
Primary outcome measures
- Safety and tolerability of TRT-448 in healthy participants [Time frame: Day 1 to Day 28]
Secondary outcome measures (4)
- Cmax [Time frame: Day 1 to Day 28]
- Tmax [Time frame: Day 1 to Day 28]
- AUClast [Time frame: Day 1 to Day 28]
- t1/2 [Time frame: Day 1 to Day 28]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07745751 · TRT-448-101