Safety and Tolerability in Healthy VolunteersPhase 1TRT-448-101NCT07745751
Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TRT-448 in Healthy Adult Subjects
A Phase 1 study testing TRT-448 in people with Safety and Tolerability in Healthy Volunteers, run by Trotana, Inc..
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability in Healthy Volunteers
- What is being tested?
- TRT-448
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 30 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
Read the 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.
- Being tested
- TRT-448, Placebo
- Keywords
- Phase 1, TRT-448, Trotana
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRT-448Drug
Investigational drug modulates immune cells for the treatment of inflammatory disease
PlaceboDrug
Inert placebo utilized as control
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of TRT-448 in healthy participants
Incidence of treatment-emergent adverse events
Measured: Day 1 to Day 28
Secondary outcomes (4)
Cmax
Maximum observed serum concentration
Measured: Day 1 to Day 28
Tmax
Time to reach maximum observed serum concentration
Measured: Day 1 to Day 28
AUClast
The area under the concentration-time curve from time zero to the time of the last observed quantifiable (non-zero) concentration
Measured: Day 1 to Day 28
t1/2
Apparent first-order terminal elimination half-life
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Tolerability in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trotana, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745751
- Sponsor's protocol ID
- TRT-448-101
- Acronym
- TRT-448-101
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07745751
- Acronym / sponsor ID
- TRT-448-101 / TRT-448-101
- Keywords
- Phase 1, TRT-448, Trotana
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Trotana, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRT-448 | Experimental | Drug: TRT-448TRT-448 dosed as oral capsules once (in single ascending dose cohorts) and daily for up to 28 days (in multiple ascending dose cohorts) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo dosed as oral capsules once (in single ascending dose cohorts) and once daily for up to 28 days (in multiple ascending dose cohorts) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRT-448Investigational drug modulates immune cells for the treatment of inflammatory disease | Drug | TRT-448 |
| PlaceboInert placebo utilized as control | Drug | Placebo |
Primary outcome
Safety and tolerability of TRT-448 in healthy participants
Time frame: Day 1 to Day 28
Incidence of treatment-emergent adverse events
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRT-448 in people with Safety and Tolerability in Healthy Volunteers, run by Trotana, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (858-926-7304, clinops@trotana.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of TRT-448 in healthy participants (time frame: Day 1 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.