The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking

Stealth BioTherapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Sterile saline (0.9%); Drug: Bendavia; Other: Cigarette smoking

Study type: Interventional

Funder types: Industry

Identifiers

NCT01518985

SPIRI-120

Details and patient eligibility

About

This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the endothelial dysfunction induced by a single cigarette.

Enrollment: 6 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult male smokers between 18 and 65 years of age with signed informed consent

Exclusion criteria

• Serum sodium level below the lower limit of sites' clinical laboratory normal range at screening, D-1 and 6
• Cholesterol level ≥ 240 mg/dL
• Hypertension (blood pressure SBP > 140, DBP > 90 mmHg)
• Body mass index < 18 or > 32 kg/m2,
• Creatinine clearance calculated by the Cockcroft and Gault method calculated to be < 90 mL/min,
• Additional laboratory abnormalities determined as clinically significant by the Principal Investigator at laboratory screening
• Clinically significant abnormalities on physical examination,
• History or evidence of renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) system dysfunction,
• History of seizures or history of epilepsy,
• History of serious (Principal Investigator judgment) mental illness,
• Receipt of investigational medicinal product within 30 days prior to the planned date of study drug administration,
• Positive serology for human immunodeficiency virus type 1 or 2, or hepatitis B surface antigen,
• Fever > 37.5°C at the time of planned dosing,
• Suspicion, or recent history, of alcohol or substance abuse,
• Donated blood or blood products within the past 30 days,
• Employee or family member of the investigational site,
• Subjects who are either unwilling to agree to refrain from use or found to be using Nicotine (or nicotine products) including cigarettes from 12 hours prior to start of each study drug infusion through to the completion of endothelial function testing, Alcohol, Caffeine, Xanthine-containing food or beverages and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement periods, Supplementary antioxidant vitamins from 7 days prior to dosing and throughout the confinement periods, Prescription medications from 14 days prior to and 7 days post treatment
• Subjects having previous exposure to Bendavia.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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6 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Intravenous infusion of saline (0.9%) for 4 hours with smoking of one unfiltered cigarette at 30 minutes post-study-drug administration start

Treatment:

Drug: Sterile saline (0.9%)

Other: Cigarette smoking

Bendavia

Experimental group

Description:

Intravenous infusion of Bendavia (0.25mg/kg/hr) for 4 hours with smoking of one unfiltered cigarette at 30 minutes post-study-drug administration start

Treatment:

Other: Cigarette smoking

Drug: Bendavia