Zofin to Treat Chronic Obstructive Pulmonary Disease (COPD)

NCT05643729 | Suspended Phase 1 DMC FDA Drug

• 1 other identifier: 27198
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion (IV) of Zofin for the Treatment of Chronic Obstructive Pulmonary Disease (COPD).

Conditions

COPD

Keywords

Zofin; Human Amniotic Fluid

Outcome Measures

Primary Outcomes (2)

• Safety of Zofin

  To demonstrate the safety of Zofin administered intravenously in subjects with COPD by measuring incidence of any of the following treatment-emergent serious adverse events (TE-SAEs) within the first 30 days of infusion: * Life-threatening event (e.g., stroke or non-fatal pulmonary embolism). * Event requiring inpatient hospitalization or prolongation of existing hospitalization (e.g., for worsening dyspnea). * Event resulting in persistent or significant disability/incapacity. * Event resulting in death. Frequency and severity of any adverse events from Day 0 (day of treatment) up to 12 months of treatment will similarly be observed.

  first 30 days

• Safety of Zofin

  To monitor the frequency and severity of adverse events

  day 0 to 12 months

Secondary Outcomes (19)

• FVC

  Screen, day 4, day 8, 4 months, 8 months and 12 months

• FEV1

  Screen, day 4, day 8, 4 months, 8 months and 12 months

• FEV1 to FVC ratio

  Screen, day 4, day 8, 4 months, 8 months and 12 months

• FEF25-75

  Screen, day 4, day 8, 4 months, 8 months and 12 months

• Lung Volume Changes

  Screen, day 4, day 8, 4 months, 8 months and 12 months

Study Arms (2)

Group 1: Zofin

EXPERIMENTAL

Group 1 Treatment Arm (10 subjects): Zofin + Standard of care (SOC) Ten subjects will receive 1 mL of Zofin on Day 0, Day 4, and Day 8, containing 1-5 x 10\^11 particles/ml. The Zofin dose will be diluted in 100 mL of sterile saline at subject's bedside. In addition to Zofin all subjects in this trial will receive SOC throughout the study period.

Drug: Zofin

Group 2: Placebo

PLACEBO COMPARATOR

Group 2 Control Arm (10 subjects): Placebo + SOC Ten subjects will receive placebo on Day 0, Day 4, and Day 8, containing 101 mL of sterile saline at subject's bedside. In addition to placebo all subjects in this trial will receive SOC throughout the study period.

Other: Placebo

Interventions

Zofin DRUG

Intravenous Infusion (IV) of Zofin

Group 1: Zofin

Placebo OTHER

Intravenous Infusion of sterile saline

Group 2: Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject who can understand and are able to provide informed consent.
• Subject with moderate to severe COPD with normal cardiac, liver and renal function
• Subject must have a post-bronchodilator FEV1/FVC ratio of less than 0.7
• Subject must have a post-bronchodilator FEV1 percent predicted value \<50%
• Subject must have a RV/TLC ratio of \> 40%
• Subject must be either a non-smoker or an ex-smoker, with a cigarette smoking history of ≥ 10 packs per year.
• Subject must have abstained from nicotine products for at least six months prior to enrollment in the study.
• Subject must be available for all specified assessments at the study site through the completion of the study.
• Subject must have oxyhemoglobin saturation on room air at rest equal or greater than 88% without oxygen
• Subject must be reasonably able to return for multiple follow-up visits.
• Adequate venous access
• For Women of Child-Bearing Potential (WOCBP) only, willingness to use FDA-recommended birth control until 6 months post treatment.
• Any male subject must agree to use contraceptives and not donate sperm during the study.

You may not qualify if:

• Subject with clinically significant illness with manifestations of significant organ dysfunction which in the judgment of the PI or co-investigator would render the study subject unlikely to tolerate the infusion or complete the study
• Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening which will be within 72 hours of the IP infusion.
• Subject has been diagnosed with a pulmonary disease other than COPD (e.g. asthma, pulmonary, fibrosis, sarcoidosis, pulmonary hypertension, bronchiolitis, interstitial lung disease)
• Subject has been diagnosed with α1-Antitrypsin deficiency
• Subject has a body mass index greater than 42 kg/m2
• Subject has or had an active infection requiring systemic antibiotics within 12 weeks on enrollment in the study
• Subject has or had exacerbation of COPD requiring hospitalization within 12 weeks of enrollment in the study.
• Subject has initiated pulmonary rehabilitation within 12 weeks of enrollment in the study
• Subject uses or used prednisone (or equivalent dose of another corticosteroid) within 12 weeks of enrollment in the study
• Subject has evidence or history of malignancy
• Subject has evidence or history of autoimmune disorders independent of COPD
• Subject is pregnant or breast-feeding
• Subject with pulmonary lobectomy or lung volume reduction surgery or lung transplantation. Subject with clinically significant bronchiectasis.
• Subject received an experimental therapy (drug or biologic) for any indication within 12 months of the study enrollment.
• Subject is unable to complete all the testing required for the study

Sponsors & Collaborators

• ZEO ScientifiX, Inc.: lead

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Natasha Phrsai

  Proxima

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study will be double blinded such that neither the patients nor the researchers will know who is getting a placebo and who is getting the treatment. Only product manufacturing staff will be un-blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a phase I/II randomized, double blinded and placebo control. The ratio between groups is 1:1 for total 20 subjects. Each subject will be randomized to receive either treatment or placebo.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: December 9, 2022
• Study Start: November 15, 2023
• Primary Completion: May 30, 2024
• Study Completion: August 31, 2024
• Last Updated: November 1, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)