Study of TB006 in Outpatient Patients With Mild to Moderate COVID-19

NCT04801056 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: TB006C1101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

TB006, a monoclonal antibody, is an anti-inflammatory and anti-fibrotic agent that reduces the severity of underlying diseases in COVID-19 patients. The primary objective of TB006 treatment is to decrease the potential acute severe deterioration in outpatient COVID-19 patients with underlying diseases, such as diabetes, hypertension, and cancer. TB006 has been developed to treat the ambulatory patients with diagnosed mild to moderate COVID-19 who are considered at low risk for severe disease or hospitalization.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Treatment emergent adverse events

  Evaluated as per DAIDS v2.1

  Baseline to Day 85

Secondary Outcomes (13)

• Pharmacokinetic parameters of TB006: AUC(0-last)

  Day 1 to Day 85

• Pharmacokinetic parameters of TB006: Cmax

  Day 1 to Day 85

• Pharmacokinetic parameters of TB006: Tmax

  Day 1 to Day 85

• Pharmacokinetic parameters of TB006: T1/2

  Day 1 to Day 85

• Immunogenicity

  Day 1 to Day 85

Other Outcomes (20)

• Pharmacodynamics biomarkers: Troponins

  Baseline to Day 28

• Pharmacodynamics biomarkers: N-terminal pro B-type natriuretic peptide (NT-proBNP)

  Baseline to Day 28

• Pharmacodynamics biomarkers: Creatine kinase-MB (CK-MB)

  Baseline to Day 28

Study Arms (2)

TB006

EXPERIMENTAL

During the SAD study, subjects will receive a single dose of TB006 (at the dosage level of 10 \~ 50 mg/kg) administered via i.v. infusion for 60 mins. In addition, a sentinel cohort of 5 mg/kg will be open for enrollment and double-blinded randomization first, with 2 patients randomized to active/TB006 arm, to assess preliminary safety and tolerability of study drug, and to determine cohort expansion and dose escalation. Upon the completion of sentinel cohort and all subjects are safe and well tolerate study treatment, regular dose escalation will start.

Drug: TB006

Placebo

PLACEBO COMPARATOR

During the SAD study, subjects will receive a single dose of the placebo administered via i.v. infusion for 60 mins. In addition, the corresponding sentinel placebo group will include 1 patient to placebo arm. Upon the completion of sentinel cohort and all subjects are safe and well tolerate study treatment, regular dose escalation will start.

Other: Placebo

Interventions

TB006 DRUG

TB006 monoclonal antibody

TB006

Placebo OTHER

Placebo i.v. infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent prior to performing study procedures (or legally authorized representative able to provide consent on the patient's behalf).
• Age ≥ 18 years
• A positive Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or an equivalent test ≤ 3 days before randomization
• Patients with mild to moderate COVID-19 experiencing any of the following symptoms:
• Mild (without shortness of breath or dyspnea): Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms
• Moderate: Any symptom of mild illness, shortness of breath with excursion, clinically suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) \> 93% on room air at sea level, heart rate ≥ 90 beats per minute
• At low risk for progressing to severe COVID-19 and/or hospitalization.
• Adequate organ function at screening as evidenced by:
• Hemoglobin \> 10.9 g/dL
• Absolute neutrophil count (ANC) \> 1.0 × 10\^9/L
• Platelets \> 125 × 10\^9/L
• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \< 1.25 × upper limit of normal (ULN)
• Creatinine clearance \> 90 mL/min using the Cockcroft-Gault formula for patients ≥ 18 years of age \[Cockcroft 1976\]
• Normal electrocardiogram with QTcF of ≤ 450 ms

You may not qualify if:

• Participation in any other clinical trial of an experimental treatment for COVID-19
• Clinical signs indicative of Severe or Critical Illness Severity
• SEVERE:
• Any symptom of severe, systematic illness, including moderate illness, shortness of breath, or respiratory distress
• Clinically suggestive of severe illness with COVID-19, such as respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, saturation of oxygen (SpO2) ≤ 93% on room air at sea level, or PaO2/FiO2 \< 300
• CRITICAL ILLNESS (one of the following):
• Respiratory failure defined based on resource utilization requiring at least one of the following:
• Endotracheal intubation and mechanical ventilation, oxygen delivered by high483 flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 L/min with fraction of delivered oxygen ≥ 0.5)
• Noninvasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)
• Shock (defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg or requiring vasopressors)
• Multi-organ dysfunction/failure
• Have a history of a positive SARS-CoV-2 serology test
• Evidence of shock (defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg or requiring vasopressors)
• Patients who are hospitalized due to COVID-19
• Patients who required oxygen therapy due to COVID-19

Sponsors & Collaborators

• TrueBinding, Inc.: lead

MeSH Terms

Conditions

COVID-19

Interventions

TB006

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Ascending Dose

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: June 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share