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

ConditionSafety and Tolerability in Healthy Volunteers
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • TRT-448

    Drug

    Investigational drug modulates immune cells for the treatment of inflammatory disease

  • Placebo

    Drug

    Inert placebo utilized as control

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: TRT-448Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability of TRT-448 in healthy participants

Incidence of treatment-emergent adverse events

Time frame
Day 1 to Day 28

Secondary outcomes

1

Cmax

Maximum observed serum concentration

Time frame
Day 1 to Day 28
2

Tmax

Time to reach maximum observed serum concentration

Time frame
Day 1 to Day 28
3

AUClast

The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration

Time frame
Day 1 to Day 28
4

t1/2

Apparent first-order terminal elimination half-life

Time frame
Day 1 to Day 28

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Trotana, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: