Healthy VolunteersPhase 1NCT05408091
Study to Evaluate Safety and Activity of TRL345 in Healthy Volunteers
A Phase 1 study testing TRL345, a human monoclonal antibody in people with Healthy Volunteers, run by Trellis Bioscience LLC at 1 site in United States.
Trial summary
This study in healthy volunteers will provide a basis for evaluation of TRL345 as a first in human study, specifically, important safety, tolerability, and pharmacokinetic data, and provide serum samples for ex vivo studies of concentration-dependent antiviral activity to support the dose selection for as well as… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TRL345, a human monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2023to 23 Dec 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and non-pregnant, non-breast-feeding female subjects at between 18 and 65 years of age, inclusive, and representative of the general population
- Willing and able to provide written informed consent.
- Availability for the entire duration of the study, and willingness to adhere to protocol requirements
- In good health, as determined by lack of clinically significant abnormalities in health assessments performed at the Screening Visit, as judged by the Principal Investigator (PI) or as delegated by the PI to a physician or nurse practitioner as sub-investigator.
- Men and women of childbearing potential (WOCBP) must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, or intrauterine device (IUD) for 28 days before Screening and through Day 76. Men must also refrain from donating sperm from Day 1 through Day 76.
Who cannot join
- Inability to tolerate blood draws or has poor venous access
- Body mass index (BMI) <18.5 or ≥35 kg/m2
- Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 160 mmHg; diastolic blood pressure lower than 50 or over 100 mmHg; or, heart rate less than 45 or over 100 bpm) at the Screening Visit
- ECG with clinically significant findings, including:
- Conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS ≥120 msec, PR interval ≥220 msec, any second- or third-degree atrioventricular block, or prolongation of the QT interval corrected according to Fridericia's correction [>450 msec male and >460 msec female])
- Significant repolarization (ST-segment or T-wave) abnormality; or
Show all 34Show fewer
- Significant atrial or ventricular arrhythmia; or
- Frequent atrial or ventricular ectopy (e.g., frequent premature atrial contractions, 2 premature ventricular contractions in a row); or
- ST-elevation consistent with ischemia or evidence of past or evolving myocardial infarction.
- Presence of any gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting),or progressive liver or kidney disease
- Diagnosis of diabetes mellitus
- History of acute or chronic pancreatitis or upper right quadrant postprandial discomfort or pain within the last 2 years
- Clinically relevant medical conditions that, in the opinion of the PI, may interfere with the evaluation of the trial drug, e.g., progressive cardiovascular disease
- Concurrent acute or chronic infections (e.g., viral infections, except chronic recurrent herpes simplex infections)
- Significant abnormal safety labs, defined as:
- Greater than 30% outside of the normal range for any of the following: hemoglobin, white blood cell (WBC) count, platelet count, neutrophil count and blood urea nitrogen
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), direct bilirubin or indirect bilirubin >2 × the upper limit of normal
- Activated partial thromboplastin time (aPTT) prolongation >1.5 x ULN
- Hemoglobin A1C (HbA1C) >5.6%
- Fasting glucose level of ≥100 mg/dl (5.6 mmol/L)
- Renal function based on the, i.e., estimated creatinine clearance < 70 mL/min (Cockcroft-Gault formula using ideal body weight)
- Hemoglobin ≤ 128 g/L (males) and ≤ 115 g/L (females), and hematocrit ≤ 37% (males) and ≤ 32.0% for females
- Positive test results for HIV, Hepatitis B (HBsAg), or Hepatitis C (HCV) at the Screening Visit
- History of significant drug abuse within one year prior to the Screening Visit and/or ongoing
- History of significant alcohol abuse within one year prior to the Screening Visit defined as more than fourteen units of alcohol per week [one "unit" is equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits)
- Positive test for drugs of abuse, ETOH and nicotine (cotinine) at the Screening Visit
- Positive serum beta-human chorionic gonadotropin test for pregnancy, pregnant, or nursing women
- Unwilling to refrain from donating blood or plasma during the study.
- Use of any new prescription medication or over-the-counter (OTC) product (including natural food supplements, vitamins, herbs) within 14 days prior to dosing
- Receipt of any vaccine or booster within 14 days prior to Day 1 or planned vaccination or booster within 4 weeks after IP administration
- Any planned medical intervention or personal event that might interfere with the ability to comply with the study requirements
- Is current study site staff paid entirely or partially by the contract for this trial, or staff who are supervised by the PI or sub-PI
- Receipt of an investigational product, or participation in another trial involving a marketed or investigational drug within 30 days of Day 1, or 5 half-lives of the investigational drug, whichever is longer
- Any other comorbidity or condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TRL345 in Healthy Volunteers
This study in healthy volunteers will provide a basis for evaluation of TRL345 as a first in human study, specifically, important safety, tolerability, and pharmacokinetic data, and provide serum samples for ex vivo studies of concentration-dependent antiviral activity to support the dose selection for as well as design and conduct of a clinical study in transplant patients.
Read the detailed description
Human cytomegalovirus (HCMV) is the most common medically significant infection in transplant patients. HCMV is usually a serious and even fatal infection in newborn SCID infants requiring hematopoietic stem cell transplant. HCMV is also the leading cause of congenital viral infection, with an incidence in the United States of 1-3% of live births. Primary HCMV infection during early pregnancy poses a 30-40% risk of intrauterine transmission. Approximately 10-15% of congenitally infected infants are symptomatic, presenting with intrauterine growth restriction and permanent birth defects, including neurological deficiencies, retinopathy, and sensori-neuronal deafness; of the infected but asymptomatic infants, 15-20% will later develop permanent sequelae. Trellis Bioscience is developing TRL345, a fully human monoclonal antibody that has specificity to the AD-2 site I in gB of HCMV, both for transplant patients and for the prevention of maternal HCMV infection during pregnancy.
Antibody therapy provides an alternative to antiviral drugs with an expectation of qualitatively lower toxicity. The leading small molecule antiviral effective against HCMV, ganciclovir (and its oral prodrug formulation valganciclovir), has side effects (including neutropenia, nephrotoxicity, and potential mutagenicity) that make its use problematic for major indications, including congenital transmission or the early post-transplant period for HCT. Although the recently approved small molecule antiviral letermovir has reduced neutropenic activity and is therefore useful in hematopoietic cell transplantation (HCT), it has not eliminated CMV reactivation in adult HCT patients.
- Conditions
- Healthy Volunteers
- Being tested
- TRL345, a human monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRL345, a human monoclonal antibodyDrug
Anti-Human Cytomegalovirus (HCMV) IgG1κ Human Monoclonal Antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 - 1 mg/kg | Experimental | Randomized 6:2 (TRL345:placebo) via IV infusion Receives: Drug: TRL345, a human monoclonal antibody |
| Dose Level 2 - 10 mg/kg | Experimental | Randomized 6:2 (TRL345:placebo) via IV infusion Receives: Drug: TRL345, a human monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Abnormal Physical Exam Findings
Clinically-significant abnormal physical exam findings will be reviewed
Measured: 11 weeks
Severity of Abnormal Physical Exam Findings
Clinically-significant abnormal physical exam findings will be reviewed. Severity scale used in this trial is Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download).
Measured: 11 weeks
Incidence of Abnormal Serum Chemistries and Hematology
Clinically-significant abnormal laboratory results findings will be reviewed
Measured: 11 weeks
Severity of Abnormal Serum Chemistries and Hematology
Clinically-significant abnormal laboratory results findings will be reviewed. Severity scale used in this trial is Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download).
Measured: 11 weeks
Incidence of Abnormal Vital Signs (Temperature)
Clinically-significant abnormal temperatures will be reviewed
Measured: 11 weeks
Severity of Abnormal Vital Signs (Temperature)
Clinically-significant abnormal temperatures will be reviewed
Measured: 11 weeks
Incidence of Abnormal Vital Signs (Blood Pressure)
Clinically-significant abnormal blood pressures will be reviewed
Measured: 11 weeks
Severity of Abnormal Vital Signs (Blood Pressure)
Clinically-significant abnormal blood pressures will be reviewed
Measured: 11 weeks
Incidence of Abnormal Vital Signs (Heart Rate)
Clinically-significant abnormal heart rates will be reviewed
Measured: 11 weeks
Severity of Abnormal Vital Signs (Heart Rate)
Clinically-significant abnormal heart rates will be reviewed
Measured: 11 weeks
Incidence and Severity of Adverse Events
reported AEs will be reviewed
Measured: 11 weeks
Incidence of Serious Adverse Events
reported SAEs will be reviewed
Measured: 11 weeks
Secondary outcomes (6)
Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (Cmax)
determined by ELISA
Measured: 11 weeks
Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (Cmin)
determined by ELISA
Measured: 11 weeks
Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (CL)
determined by ELISA
Measured: 11 weeks
Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (Vss)
determined by ELISA
Measured: 11 weeks
Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (T1/2)
determined by ELISA
Measured: 11 weeks
Assess the Immunogenicity of TRL345 as Measured by Anti-drug Antibodies (ADAs)
Incidence of baseline and IP-emergent ADA (i.e., anti-TRL345 antibodies) in serum will determined by electrochemiluminescence assay
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start14 Sep 2023
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trellis Bioscience LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408091
- Sponsor's protocol ID
- TRL345-102
- Status last verified
- May 2026
- First submitted
- 2 May 2022
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kotton CN, Kumar D, Caliendo AM, Huprikar S, Chou S, Danziger-Isakov L, Humar A; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018 Jun;102(6):900-931. doi: 10.1097/TP.0000000000002191.
PubMed 29596116Fowler KB, Stagno S, Pass RF, Britt WJ, Boll TJ, Alford CA. The outcome of congenital cytomegalovirus infection in relation to maternal antibody status. N Engl J Med. 1992 Mar 5;326(10):663-7. doi: 10.1056/NEJM199203053261003.
PubMed 1310525Stagno S, Pass RF, Cloud G, Britt WJ, Henderson RE, Walton PD, Veren DA, Page F, Alford CA. Primary cytomegalovirus infection in pregnancy. Incidence, transmission to fetus, and clinical outcome. JAMA. 1986 Oct 10;256(14):1904-8.
PubMed 3020264Turner KM, Lee HC, Boppana SB, Carlo WA, Randolph DA. Incidence and impact of CMV infection in very low birth weight infants. Pediatrics. 2014 Mar;133(3):e609-15. doi: 10.1542/peds.2013-2217. Epub 2014 Feb 2.
PubMed 24488749Kalil AC, Freifeld AG, Lyden ER, Stoner JA. Valganciclovir for cytomegalovirus prevention in solid organ transplant patients: an evidence-based reassessment of safety and efficacy. PLoS One. 2009;4(5):e5512. doi: 10.1371/journal.pone.0005512. Epub 2009 May 13.
PubMed 19436751Marty FM, Ljungman PT, Chemaly RF, Wan H, Teal VL, Butterton JR, Yeh WW, Leavitt RY, Badshah CS. Outcomes of patients with detectable CMV DNA at randomization in the phase III trial of letermovir for the prevention of CMV infection in allogeneic hematopoietic cell transplantation. Am J Transplant. 2020 Jun;20(6):1703-1711. doi: 10.1111/ajt.15764. Epub 2020 Jan 18.
PubMed 31883426
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TRL345 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05408091
- Acronym / sponsor ID
- TRL345-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Trellis Bioscience LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Posted 27 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study in healthy volunteers will provide a basis for evaluation of TRL345 as a first in human study, specifically, important safety, tolerability, and pharmacokinetic data, and provide serum samples for ex vivo studies of concentration-dependent antiviral activity to support the dose selection for as well as design and conduct of a clinical study in transplant patients.
Detailed description
Human cytomegalovirus (HCMV) is the most common medically significant infection in transplant patients. HCMV is usually a serious and even fatal infection in newborn SCID infants requiring hematopoietic stem cell transplant. HCMV is also the leading cause of congenital viral infection, with an incidence in the United States of 1-3% of live births. Primary HCMV infection during early pregnancy poses a 30-40% risk of intrauterine transmission. Approximately 10-15% of congenitally infected infants are symptomatic, presenting with intrauterine growth restriction and permanent birth defects, including neurological deficiencies, retinopathy, and sensori-neuronal deafness; of the infected but asymptomatic infants, 15-20% will later develop permanent sequelae. Trellis Bioscience is developing TRL345, a fully human monoclonal antibody that has specificity to the AD-2 site I in gB of HCMV, both for transplant patients and for the prevention of maternal HCMV infection during pregnancy.
Antibody therapy provides an alternative to antiviral drugs with an expectation of qualitatively lower toxicity. The leading small molecule antiviral effective against HCMV, ganciclovir (and its oral prodrug formulation valganciclovir), has side effects (including neutropenia, nephrotoxicity, and potential mutagenicity) that make its use problematic for major indications, including congenital transmission or the early post-transplant period for HCT. Although the recently approved small molecule antiviral letermovir has reduced neutropenic activity and is therefore useful in hematopoietic cell transplantation (HCT), it has not eliminated CMV reactivation in adult HCT patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 - 1 mg/kg | Experimental | Drug: TRL345, a human monoclonal antibodyRandomized 6:2 (TRL345:placebo) via IV infusion |
| Dose Level 2 - 10 mg/kg | Experimental | Drug: TRL345, a human monoclonal antibodyRandomized 6:2 (TRL345:placebo) via IV infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male and non-pregnant, non-breast-feeding female subjects at between 18 and 65 years of age, inclusive, and representative of the general population
- Willing and able to provide written informed consent.
- Availability for the entire duration of the study, and willingness to adhere to protocol requirements
- In good health, as determined by lack of clinically significant abnormalities in health assessments performed at the Screening Visit, as judged by the Principal Investigator (PI) or as delegated by the PI to a physician or nurse practitioner as sub-investigator.
- Men and women of childbearing potential (WOCBP) must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, or intrauterine device (IUD) for 28 days before Screening and through Day 76. Men must also refrain from donating sperm from Day 1 through Day 76.
Key exclusion criteria (34 listed)
- Inability to tolerate blood draws or has poor venous access
- Body mass index (BMI) <18.5 or ≥35 kg/m2
- Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 160 mmHg; diastolic blood pressure lower than 50 or over 100 mmHg; or, heart rate less than 45 or over 100 bpm) at the Screening Visit
- ECG with clinically significant findings, including:
- Presence of any gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting),or progressive liver or kidney disease
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 |
|---|---|---|
| TRL345, a human monoclonal antibodyAnti-Human Cytomegalovirus (HCMV) IgG1κ Human Monoclonal Antibody | Drug | Dose Level 1 - 1 mg/kg, Dose Level 2 - 10 mg/kg |
Primary outcome
Incidence of Abnormal Physical Exam Findings
Time frame: 11 weeks
Clinically-significant abnormal physical exam findings will be reviewed
Severity of Abnormal Physical Exam Findings
Time frame: 11 weeks
Clinically-significant abnormal physical exam findings will be reviewed. Severity scale used in this trial is Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download).
Incidence of Abnormal Serum Chemistries and Hematology
Time frame: 11 weeks
Clinically-significant abnormal laboratory results findings will be reviewed
Severity of Abnormal Serum Chemistries and Hematology
Time frame: 11 weeks
Clinically-significant abnormal laboratory results findings will be reviewed. Severity scale used in this trial is Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download).
Incidence of Abnormal Vital Signs (Temperature)
Time frame: 11 weeks
Clinically-significant abnormal temperatures will be reviewed
Severity of Abnormal Vital Signs (Temperature)
Time frame: 11 weeks
Clinically-significant abnormal temperatures will be reviewed
Incidence of Abnormal Vital Signs (Blood Pressure)
Time frame: 11 weeks
Clinically-significant abnormal blood pressures will be reviewed
Severity of Abnormal Vital Signs (Blood Pressure)
Time frame: 11 weeks
Clinically-significant abnormal blood pressures will be reviewed
Incidence of Abnormal Vital Signs (Heart Rate)
Time frame: 11 weeks
Clinically-significant abnormal heart rates will be reviewed
Severity of Abnormal Vital Signs (Heart Rate)
Time frame: 11 weeks
Clinically-significant abnormal heart rates will be reviewed
Incidence and Severity of Adverse Events
Time frame: 11 weeks
reported AEs will be reviewed
Incidence of Serious Adverse Events
Time frame: 11 weeks
reported SAEs will be reviewed
6 secondary outcomes
Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (Cmax)
Time frame: 11 weeks
Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (Cmin)
Time frame: 11 weeks
Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (CL)
Time frame: 11 weeks
Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (Vss)
Time frame: 11 weeks
Characterize the Pharmacokinetics (PK) of a Single IV Infusion of TRL345 Overall and by DG (T1/2)
Time frame: 11 weeks
Assess the Immunogenicity of TRL345 as Measured by Anti-drug Antibodies (ADAs)
Time frame: 11 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29596116Kotton CN, Kumar D, Caliendo AM, Huprikar S, Chou S, Danziger-Isakov L, Humar A; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018 Jun;102(6):900-931. doi: 10.1097/TP.0000000000002191.
- Background: PubMed 1310525Fowler KB, Stagno S, Pass RF, Britt WJ, Boll TJ, Alford CA. The outcome of congenital cytomegalovirus infection in relation to maternal antibody status. N Engl J Med. 1992 Mar 5;326(10):663-7. doi: 10.1056/NEJM199203053261003.
- Background: PubMed 3020264Stagno S, Pass RF, Cloud G, Britt WJ, Henderson RE, Walton PD, Veren DA, Page F, Alford CA. Primary cytomegalovirus infection in pregnancy. Incidence, transmission to fetus, and clinical outcome. JAMA. 1986 Oct 10;256(14):1904-8.
- Background: PubMed 24488749Turner KM, Lee HC, Boppana SB, Carlo WA, Randolph DA. Incidence and impact of CMV infection in very low birth weight infants. Pediatrics. 2014 Mar;133(3):e609-15. doi: 10.1542/peds.2013-2217. Epub 2014 Feb 2.
- Background: PubMed 19436751Kalil AC, Freifeld AG, Lyden ER, Stoner JA. Valganciclovir for cytomegalovirus prevention in solid organ transplant patients: an evidence-based reassessment of safety and efficacy. PLoS One. 2009;4(5):e5512. doi: 10.1371/journal.pone.0005512. Epub 2009 May 13.
- Background: PubMed 31883426Marty FM, Ljungman PT, Chemaly RF, Wan H, Teal VL, Butterton JR, Yeh WW, Leavitt RY, Badshah CS. Outcomes of patients with detectable CMV DNA at randomization in the phase III trial of letermovir for the prevention of CMV infection in allogeneic hematopoietic cell transplantation. Am J Transplant. 2020 Jun;20(6):1703-1711. doi: 10.1111/ajt.15764. Epub 2020 Jan 18.
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Screening Protocol
Pain
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRL345, a human monoclonal antibody in people with Healthy Volunteers, run by Trellis Bioscience LLC at 1 site in United States.
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 5 inclusion and 34 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: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 27 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Abnormal Physical Exam Findings (time frame: 11 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05408091, which also lists 6 linked publications.
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 25 Jun 2026.