Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TRT-448 in Healthy Adult Subjects
NCT07745751 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2026-08-06
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
Interventions
- DRUG
-
TRT-448
Investigational drug modulates immune cells for the treatment of inflammatory disease
- DRUG
-
Inert placebo utilized as control
Sponsors & Collaborators
-
Trotana, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-08-30
- Primary Completion
- 2027-04-01
- Completion
- 2027-05-30
More Related Trials
-
Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency
NCT00161304 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism
NCT02777242 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen
NCT04545450 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
NCT00467870 ·Status: COMPLETED ·Phase: PHASE3
-
Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?
NCT05964920 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (MK-0000-064)
NCT00816712 ·Status: COMPLETED ·Phase: PHASE1
-
Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents
NCT03864913 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Effects of TAK-448 in Middle-aged and Older Men With Low Testosterone
NCT02381288 ·Status: TERMINATED ·Phase: PHASE2
-
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
NCT03792477 ·Status: COMPLETED ·Phase: PHASE1
-
The Testosterone Trials in Older Men
NCT00799617 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Safety, Tolerability and Pharmacokinetics of Testosterone Undecanoate in Hypogonadal Males.
NCT01346319 ·Status: COMPLETED ·Phase: PHASE1
-
Study of 3 Doses of ARD-0403 in Testosterone Deficient Men
NCT00597051 ·Status: COMPLETED ·Phase: PHASE2
-
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
NCT06689085 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy and Safety of Testogel® in Men With Partial Androgen Deficiency of Aging Males (PADAM)
NCT00185198 ·Status: COMPLETED ·Phase: PHASE3
-
Testopel ® vs. Generic Testosterone Pellets.
NCT04523480 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of an Intranasal Testosterone Product
NCT01252745 ·Status: COMPLETED ·Phase: PHASE2
-
Does Testosterone Improve Function in Hypogonadal Older Men
NCT00304213 ·Status: WITHDRAWN ·Phase: PHASE4
-
TEAM: Testosterone Supplementation and Exercise in Elderly Men
NCT00112151 ·Status: COMPLETED ·Phase: PHASE2
-
Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism
NCT00220298 ·Status: COMPLETED ·Phase: PHASE3
-
Testosterone Treatment in Men With Chronic Kidney Disease
NCT05249634 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Testosterone and Athlete Response
NCT03210558 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Test Safety, Tolerability and Blood Levels of GSK971086 After 1 Dose & 7 Days of Dosing in Healthy Adult Males
NCT00540553 ·Status: COMPLETED ·Phase: PHASE1
-
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
NCT04301765 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Subcutaneous vs. Intramuscular Testosterone
NCT03091348 ·Status: COMPLETED ·Phase: PHASE4
-
Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
NCT00957034 ·Status: TERMINATED ·Phase: PHASE2