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Trial Outcomes & Findings for Study to Evaluate Safety and Activity of TRL345 in Healthy Volunteers (NCT NCT05408091)

NCT ID: NCT05408091

Last Updated: 2026-05-27

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

11 weeks

Results posted on

2026-05-27

Participant Flow

Recruitment for this study was completed in roughly 2 weeks for each cohort at a CRO with a Phase 1 unit. Primary method to find participants that were interested was engaging the CRO's participant database to make people aware of the study opportunity. Interested participants could contact their call center for more information or go online to view the study details and register for an upcoming screening.

Participant milestones

Participant milestones
Measure
Dose Level 1 - 1 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Dose Level 2 - 10 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
Pooled, N=4
Overall Study
STARTED
6
6
4
Overall Study
COMPLETED
6
5
4
Overall Study
NOT COMPLETED
0
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Dose Level 1 - 1 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Dose Level 2 - 10 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
Pooled, N=4
Overall Study
Withdrawal by Subject
0
1
0

Baseline Characteristics

Study to Evaluate Safety and Activity of TRL345 in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dose Level 1 - 1 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Dose Level 2 - 10 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
n=4 Participants
Pooled, N=4
Total
n=16 Participants
Total of all reporting groups
Age, Customized
Age
39.8 years
STANDARD_DEVIATION 6.85 • n=51 Participants
43.5 years
STANDARD_DEVIATION 11.27 • n=14 Participants
48.8 years
STANDARD_DEVIATION 11.56 • n=65 Participants
43.4 years
STANDARD_DEVIATION 9.87 • n=24 Participants
Sex: Female, Male
Female
4 Participants
n=51 Participants
3 Participants
n=14 Participants
2 Participants
n=65 Participants
9 Participants
n=24 Participants
Sex: Female, Male
Male
2 Participants
n=51 Participants
3 Participants
n=14 Participants
2 Participants
n=65 Participants
7 Participants
n=24 Participants
Race/Ethnicity, Customized
Black or African American
1 Participants
n=51 Participants
1 Participants
n=14 Participants
0 Participants
n=65 Participants
2 Participants
n=24 Participants
Race/Ethnicity, Customized
White
4 Participants
n=51 Participants
5 Participants
n=14 Participants
4 Participants
n=65 Participants
13 Participants
n=24 Participants
Race/Ethnicity, Customized
White, Asian
1 Participants
n=51 Participants
0 Participants
n=14 Participants
0 Participants
n=65 Participants
1 Participants
n=24 Participants
Race/Ethnicity, Customized
Hispanic or Latino
5 Participants
n=51 Participants
4 Participants
n=14 Participants
3 Participants
n=65 Participants
12 Participants
n=24 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
1 Participants
n=51 Participants
2 Participants
n=14 Participants
1 Participants
n=65 Participants
4 Participants
n=24 Participants

PRIMARY outcome

Timeframe: 11 weeks

Clinically-significant abnormal physical exam findings will be reviewed

Outcome measures

Outcome measures
Measure
Dose Level 2 - 10 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
n=4 Participants
Pooled, N=4
Dose Level 1 - 1 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Incidence of Abnormal Physical Exam Findings
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 11 weeks

Population: No subject had an abnormal physical exam finding.

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).

Outcome measures

Outcome measures
Measure
Dose Level 2 - 10 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
Pooled, N=4
Dose Level 1 - 1 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Severity of Abnormal Physical Exam Findings
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 11 weeks

Clinically-significant abnormal laboratory results findings will be reviewed

Outcome measures

Outcome measures
Measure
Dose Level 2 - 10 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
n=4 Participants
Pooled, N=4
Dose Level 1 - 1 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Incidence of Abnormal Serum Chemistries and Hematology
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 11 weeks

Population: No subject had an abnormal serum chemistry or 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).

Outcome measures

Outcome measures
Measure
Dose Level 2 - 10 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
Pooled, N=4
Dose Level 1 - 1 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Severity of Abnormal Serum Chemistries and Hematology
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 11 weeks

Clinically-significant abnormal temperatures will be reviewed

Outcome measures

Outcome measures
Measure
Dose Level 2 - 10 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
n=4 Participants
Pooled, N=4
Dose Level 1 - 1 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Incidence of Abnormal Vital Signs (Temperature)
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 11 weeks

Population: No subject had an abnormal temperature.

Clinically-significant abnormal temperatures will be reviewed

Outcome measures

Outcome measures
Measure
Dose Level 2 - 10 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
Pooled, N=4
Dose Level 1 - 1 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Severity of Abnormal Vital Signs (Temperature)
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 11 weeks

Clinically-significant abnormal blood pressures will be reviewed

Outcome measures

Outcome measures
Measure
Dose Level 2 - 10 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
n=4 Participants
Pooled, N=4
Dose Level 1 - 1 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Incidence of Abnormal Vital Signs (Blood Pressure)
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 11 weeks

Population: No subject had an abnormal blood pressure.

Clinically-significant abnormal blood pressures will be reviewed

Outcome measures

Outcome measures
Measure
Dose Level 2 - 10 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
Pooled, N=4
Dose Level 1 - 1 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Severity of Abnormal Vital Signs (Blood Pressure)
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 11 weeks

Clinically-significant abnormal heart rates will be reviewed

Outcome measures

Outcome measures
Measure
Dose Level 2 - 10 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
n=4 Participants
Pooled, N=4
Dose Level 1 - 1 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Incidence of Abnormal Vital Signs (Heart Rate)
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 11 weeks

Population: No subject had an abnormal heart rate.

Clinically-significant abnormal heart rates will be reviewed

Outcome measures

Outcome measures
Measure
Dose Level 2 - 10 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
Pooled, N=4
Dose Level 1 - 1 mg/kg
Randomized 6:2 (TRL345:placebo) via IV infusion
Severity of Abnormal Vital Signs (Heart Rate)
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 11 weeks

reported AEs will be reviewed

Outcome measures

Outcome measures
Measure
Dose Level 2 - 10 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
n=4 Participants
Pooled, N=4
Dose Level 1 - 1 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Incidence and Severity of Adverse Events
2 Participants
1 Participants
2 Participants

PRIMARY outcome

Timeframe: 11 weeks

Population: No SAEs were reported.

reported SAEs will be reviewed

Outcome measures

Outcome measures
Measure
Dose Level 2 - 10 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
n=4 Participants
Pooled, N=4
Dose Level 1 - 1 mg/kg
n=6 Participants
Randomized 6:2 (TRL345:placebo) via IV infusion
Incidence of Serious Adverse Events
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 11 weeks

determined by ELISA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 weeks

determined by ELISA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 weeks

determined by ELISA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 weeks

determined by ELISA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 weeks

determined by ELISA

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 weeks

Incidence of baseline and IP-emergent ADA (i.e., anti-TRL345 antibodies) in serum will determined by electrochemiluminescence assay

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 11 weeks

Additional serum samples will be taken at various pharmacokinetic assessment timepoints and therefore will have different concentrations of TRL345. These samples will be used to explore the capacity of various concentrations of TRL345, as documented by the PK determinations, to neutralize CMV in human serum in ex vivo assessments.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 11 weeks

These comparisons will be done to explore if there are any signs of off-target binding of TRL345. Gastrointestinal and CNS adverse effects will be compared for any qualitative or quantitative differences in such events.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

These comparisons will be done to explore if there are any signs of off-target binding of TRL345. LDH, hsCRP, and IL-1alpha will be compared.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 11 weeks

These comparisons will be done to explore if there are any signs of off-target binding of TRL345. Estimated AUC will be compared.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 11 weeks

These comparisons will be done to explore if there are any signs of off-target binding of TRL345. Estimated T1/2 will be compared.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 11 weeks

Gastrointestinal and CNS adverse events will be compared across DGs for any qualitative or quantitative differences in such events.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

LDH will be compared across DGs

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

hsCRP will be compared across DGs

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

IL-1alpha will be compared across DGs

Outcome measures

Outcome data not reported

Adverse Events

Dose Level 1 - 1 mg/kg

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Dose Level 2 - 10 mg/kg

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Dose Level 1 - 1 mg/kg
n=6 participants at risk
Randomized 6:2 (TRL345:placebo) via IV infusion
Dose Level 2 - 10 mg/kg
n=6 participants at risk
Randomized 6:2 (TRL345:placebo) via IV infusion
Placebo
n=4 participants at risk
Pooled, N=4
Respiratory, thoracic and mediastinal disorders
productive cough
0.00%
0/6 • from first dose (Day 1) through end of study (Day 76)
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
0.00%
0/4 • from first dose (Day 1) through end of study (Day 76)
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
0.00%
0/4 • from first dose (Day 1) through end of study (Day 76)
Nervous system disorders
nasal congestion
0.00%
0/6 • from first dose (Day 1) through end of study (Day 76)
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
0.00%
0/4 • from first dose (Day 1) through end of study (Day 76)
Gastrointestinal disorders
abdominal distension
0.00%
0/6 • from first dose (Day 1) through end of study (Day 76)
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
0.00%
0/4 • from first dose (Day 1) through end of study (Day 76)
Gastrointestinal disorders
abdominal pain
0.00%
0/6 • from first dose (Day 1) through end of study (Day 76)
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
25.0%
1/4 • from first dose (Day 1) through end of study (Day 76)
Gastrointestinal disorders
diarrhoea
0.00%
0/6 • from first dose (Day 1) through end of study (Day 76)
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
25.0%
1/4 • from first dose (Day 1) through end of study (Day 76)
Gastrointestinal disorders
gastrooesophageal reflux disease
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
0.00%
0/6 • from first dose (Day 1) through end of study (Day 76)
0.00%
0/4 • from first dose (Day 1) through end of study (Day 76)
Gastrointestinal disorders
nausea
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
0.00%
0/4 • from first dose (Day 1) through end of study (Day 76)
Nervous system disorders
dizziness
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
0.00%
0/6 • from first dose (Day 1) through end of study (Day 76)
0.00%
0/4 • from first dose (Day 1) through end of study (Day 76)
Nervous system disorders
headache
33.3%
2/6 • from first dose (Day 1) through end of study (Day 76)
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
0.00%
0/4 • from first dose (Day 1) through end of study (Day 76)
Respiratory, thoracic and mediastinal disorders
cough
0.00%
0/6 • from first dose (Day 1) through end of study (Day 76)
16.7%
1/6 • from first dose (Day 1) through end of study (Day 76)
0.00%
0/4 • from first dose (Day 1) through end of study (Day 76)

Additional Information

Adriane Kisch-Hancock

Trellis Bioscience, Inc.

Phone: 925-876-9878

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place