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NCT07644195

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

Not Yet Recruiting
PHASE1Ages 18–65InterventionalTreatment
Trellis Bioscience LLC
~14 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:TRL1068, a human monoclonal antibody

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of abnormal physical exam findings
Measured over 30 days
+11 more outcomes measured

Conditions

Healthy Volunteer

Explore related trials

Healthy Volunteers

Where it's being run

1 sites across 1 states
Nebraska1

Who to contact

Anton (Tony) Leighton, MD
[email protected]
650-838-1400
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Eligibility criteria

Exclusion

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
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 8. Positive test results for HIV, Hepatitis B (HBsAg), or Hepatitis C (HCV) at the Screening Visit 9. History of significant drug abuse within one year prior to the Screening Visit and/or ongoing 10. 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) 11. Positive test for drugs of abuse, ETOH and nicotine (cotinine) at the Screening Visit 12. Positive serum beta-human chorionic gonadotropin test for pregnancy, pregnant, or nursing women 13. Unwilling to refrain from donating blood or plasma during the study 14. Use of any new prescription medication or over-the-counter (OTC) product (including natural food supplements, vitamins, herbs) within 14 days prior to dosing 15. Receipt of any vaccine or booster within 14 days prior to Day 1 or planned vaccination or booster within 4 weeks after IP administration 16. Any planned medical intervention or personal event that might interfere with the ability to comply with the study requirements 17. 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 18. 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 19. 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

What this trial measures

  • Incidence of abnormal physical exam findings30 days

    Clinically-significant abnormal physical exam findings will be reviewed

  • Severity of abnormal physical exam findings30 days

    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 hematology30 days

    Clinically-significant abnormal laboratory results findings will be reviewed

  • Severity of abnormal serum chemistries and hematology30 days

    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)30 days

    Clinically-significant abnormal temperatures will be reviewed

  • Severity of abnormal vital signs (temperature)30 days

    Clinically-significant abnormal temperatures will be reviewed

  • Incidence of abnormal vital signs (blood pressure)30 days

    Clinically-significant abnormal blood pressures will be reviewed

  • Severity of abnormal vital signs (blood pressure)30 days

    Clinically-significant abnormal blood pressures will be reviewed

  • Incidence of abnormal vital signs (heart rate)30 days

    Clinically-significant abnormal heart rates will be reviewed

  • Severity of abnormal vital signs (heart rate)30 days

    Clinically-significant abnormal heart rates will be reviewed

  • Incidence and Severity of Adverse Events30 days

    reported AEs will be reviewed

  • Incidence of Serious Adverse Events30 days

    reported SAEs will be reviewed