Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome
The Safety, Pharmacokinetics, and Pharmacodynamic Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome
1 other identifier
interventional
18
2 countries
7
Brief Summary
This Phase I/IIa, multi-center, randomized, placebo-controlled, single-blinded dose-escalation study evaluated TNX-832 (also referred to as ALT-836 and Sunol cH36) in subjects with suspected or proven bacteria-induced ALI/ARDS. Up to five cohorts of at least six subjects each were originally planned. Subjects were to be randomized in a 5:1 ratio to receive TNX-832 or placebo,respectively, administered as a single bolus infusion over 15 minutes. Three cohorts of subjects were enrolled to the study and safety and pharmacokinetics of the study treatment were evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 sepsis
Started Dec 2004
Longer than P75 for phase_1 sepsis
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
September 22, 2011
CompletedResults Posted
Study results publicly available
January 6, 2025
CompletedJanuary 6, 2025
August 1, 2024
1.6 years
September 20, 2011
August 8, 2024
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number of Participants With Adverse Events
To evaluate the safety of escalating dose levels of TNX-832 in subjects with suspected or proven bacteria-induced ALI/ARDS. Safety was assessed by number of treatment emergent adverse events, and changes in vital signs, ECGs, laboratory, coagulation and pulmonary function parameters from baseline. Immunogenicity (serum anti-TNX-832 antibody response) was evalutated.
Up to 4 weeks
Cmax
maximum observed concentration (Cmax)
predose; 15 and 30 min; 1, 4, 6, 12 and 24 hrs; 2, 3, 4, 5, 6, and 7 days, 2, 3, 4 weeks
AUCinf and AUClast
Area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf). AUClast (area under the serum concentration-time curve from the time of dosing to the time of the last observed concentration).
Up 163.3 hours
Terminal t1/2 and Tmax
t1/2 (terminal elimination phase half life). Tmax (time to maximum serum concentration).
predose; 15 and 30 min; 1, 4, 6, 12 and 24 hrs; 2, 3, 4, 5, 6, and 7 days, 2, 3, 4 weeks
Vd and Vss
Volume of distribution (Vd) based on the terminal elimination phase, also referred to as VZ; in mL/kg. Volume of distribution at steady state (Vss), calculated as the Mean residence Time times Clearance; in mL/kg.
predose; 15 and 30 min; 1, 4, 6, 12 and 24 hrs; 2, 3, 4, 5, 6, and 7 days, 2, 3, 4 weeks
Cl
Total body clearance, CL=Dose/AUC; in mL/hr/kg
up to 1 week
Study Arms (2)
TNX-832
EXPERIMENTALAnti-tissue factor antibody
Drug Placebo
PLACEBO COMPARATORPlacebo control
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 18 years
- Suspected or proven bacterial infection
- Receiving positive pressure ventilation through an endotracheal tube
- Have ALI/ARDS, defined as having all of the following:
- bilateral infiltrates consistent with pulmonary edema
- Hypoxemia
- no clinical evidence of left atrial hypertension
- Provide signed informed consent
You may not qualify if:
- Mechanically or chemically-induced ALI/ARDS (including burns, trauma, and near drowning)
- End-stage lung disease
- Decompensated congestive heart failure
- Authorization to withdraw life support
- Hemoglobin persistently \<8.0 g/dL
- Subjects who have any one of the following:
- platelet count \<50,000/mm\^3
- prolonged prothrombin time (PT)
- prolonged activated partial thromboplastin time (aPTT)
- having significant potential for disseminated intravascular coagulation (DIC)
- Subjects who have two or more of the following:
- prolonged aPTT
- fibrinogen level below the lower limit of normal
- presence of petechiae, ecchymoses, or other evidence of coagulopathy
- Subjects who have a history of one or more of the following:
- +33 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Altor BioSciencelead
- Genentech, Inc.collaborator
- Tanoxcollaborator
Study Sites (7)
University of Miami
Miami, Florida, 33125, United States
Beth Israel Deconess Medical Center
Boston, Massachusetts, 02215, United States
Washington University
St Louis, Missouri, 63130, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Baylor School of Medicine
Houston, Texas, 77030, United States
Capital Health
Halifax, Nova Scotia, B3H 1V7, Canada
Related Publications (1)
Morris PE, Steingrub JS, Huang BY, Tang S, Liu PM, Rhode PR, Wong HC. A phase I study evaluating the pharmacokinetics, safety and tolerability of an antibody-based tissue factor antagonist in subjects with acute lung injury or acute respiratory distress syndrome. BMC Pulm Med. 2012 Feb 16;12:5. doi: 10.1186/1471-2466-12-5.
PMID: 22340260DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sandeep Bobby Reddy, Chief Medical Office
- Organization
- ImmunityBio
Study Officials
- STUDY DIRECTOR
Hing Wong, PhD
Altor BioScience
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2011
First Posted
September 22, 2011
Study Start
December 1, 2004
Primary Completion
July 1, 2006
Study Completion
February 1, 2008
Last Updated
January 6, 2025
Results First Posted
January 6, 2025
Record last verified: 2024-08