Study to Evaluate Safety and Activity of Inhaled TRL1068 in Healthy Volunteers

NCT07644195 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TRL1068-108
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study in healthy volunteers will provide a basis for evaluation of inhaled TRL1068 as a first in human study, specifically, important safety, tolerability, and pharmacokinetic data.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (12)

• Incidence of abnormal physical exam findings

  Clinically-significant abnormal physical exam findings will be reviewed

  30 days

• 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).

  30 days

• Incidence of abnormal serum chemistries and hematology

  Clinically-significant abnormal laboratory results findings will be reviewed

  30 days

• 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).

  30 days

• Incidence of abnormal vital signs (temperature)

  Clinically-significant abnormal temperatures will be reviewed

  30 days

• Severity of abnormal vital signs (temperature)

  Clinically-significant abnormal temperatures will be reviewed

  30 days

• Incidence of abnormal vital signs (blood pressure)

  Clinically-significant abnormal blood pressures will be reviewed

  30 days

• Severity of abnormal vital signs (blood pressure)

  Clinically-significant abnormal blood pressures will be reviewed

  30 days

• Incidence of abnormal vital signs (heart rate)

  Clinically-significant abnormal heart rates will be reviewed

  30 days

• Severity of abnormal vital signs (heart rate)

  Clinically-significant abnormal heart rates will be reviewed

  30 days

• Incidence and Severity of Adverse Events

  reported AEs will be reviewed

  30 days

• Incidence of Serious Adverse Events

  reported SAEs will be reviewed

  30 days

Secondary Outcomes (6)

• Characterize the pharmacokinetics (PK) of inhaled TRL1068 overall and by DG (Cmax)

  8 days

• Characterize the pharmacokinetics (PK) of inhaled TRL1068 overall and by DG (Cmin)

  8 days

• Characterize the pharmacokinetics (PK) of inhaled TRL1068 overall and by DG (CL)

  8 days

• Characterize the pharmacokinetics (PK) of inhaled TRL1068 overall and by DG (Vss)

  8 days

• Characterize the pharmacokinetics (PK) of inhaled TRL1068 overall and by DG (T1/2)

  8 days

Study Arms (2)

Single Dose

EXPERIMENTAL

Randomized 5:2 (TRL1068:placebo) via inhalation. Administered once on Day 1.

Drug: TRL1068, a human monoclonal antibody

Multiple Dose

EXPERIMENTAL

Randomized 5:2 (TRL1068:placebo) via inhalation. Administered four times, on Days 1, 3, 5, and 7.

Drug: TRL1068, a human monoclonal antibody

Interventions

TRL1068, a human monoclonal antibody DRUG

The IP will be in a solution for inhalation at a nominal concentration of 20 mg/mL. The IP will be reconstituted with a formulation buffer to 10 mg/mL/PS20 0.055% and dosed at a fixed dose of 60 mg per dose (volume of 6 mL) to full completion. Placebo will be normal saline. This study will use a marketed nebulizer device, the Aerogen Solo™, which is designed to generate an aerosol to achieve effective levels of TRL1068 in distal airways.

Multiple Dose; Single Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Normal spirometry at Screening, defined as FEV1 ≥ 80%
• 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 for 90 days after Day 1. Men must also refrain from donating sperm from Day 1 and for 90 days after Day 1.

You may not qualify if:

• 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
• Clinical diagnosis of acute or chronic viral or bacterial infection with the exception of chronic recurrent herpes simplex infection
• 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
• 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
• 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

Sponsors & Collaborators

• Trellis Bioscience LLC: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

TRL1068

Central Study Contacts

Anton (Tony) Leighton, MD

CONTACT

650-838-1400; clinicalstudies@trellisbio.com

Adriane Kisch-Hancock

CONTACT

650-838-1400; AKisch-Hancock@trellisbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

US (1)