Study of the use of the drug Thymosin alpha 1 in adults patients with Cystic Fibrosis.

Prior treatment

• Ongoing or prior participation in an investigational drug study within 30 days of screening.
• Intravenous antibiotic use in the last 4 weeks before screening.
• Treatment with oxygen.
• History or presence of alcoholism or drug abuse within 2 years prior to the screening.

Other illness

• Any malignancy or chronic organ failure or disease that depart from the patient's usual baseline level of health as a patient with CF.
• History of organ or hematological transplantation.

Lab values

• Clinical/laboratory/radiological/spirometric signs of unstable or unexpectedly deteriorating respiratory disease (30 days prior to the screening).
• History of allergy, hypersensitivity, intolerance to Thymosin alpha1 and to its excipients (Mannitol, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate)
• Kidney (creatinine 2-fold of the normal upper limit) or hepatic alterations (Child Pugh score equal to B or C).
• Personal or family history of prolonged QT syndrome; or a QTc interval >430 msec (males) or > 450 msec (females) using Bazett's formula (QTcB) or deemed clinically significant by the PI.

Other

• In the judgment of the PI, clinically significant hemoptysis (>30 ml per episode) within the last 180 days.
• Patients with “F508del homozygous mutation” treated successfully with corrector potentiators, according to physicians’ judgment.

• Male or female, from 18 years of age (inclusive) at the time of screening.
• Blood pressure: DBP values between 60 and 89 mmHg, and SBP values between 90 and 139 mmHg. ECG normal or wave changes not considered clinically significant.
• Pulse betweem 50 and 120 bpm unless deemed clinically. insignificant by the PI.
• Signed Informed Consent.
• Confirmed diagnosis of CF, based on the following: two sweat chloride tests with a result = 60 mEq/L or two CFTR mutations on genetic test.
• CF diagnosis independently of genetic mutations.
• Clinical stability with no change in symptoms and/or medication within 4 weeks prior to screening.
• Body mass index (BMI) = 15.0 (kg/m2).
• Non-tobacco/nicotine-containing product user for a minimum of 6 months prior to screening.
• Percent Predicted Forced Expiratory Volume (ppFEV1) > 40%, predicted at screening.
• Female with pregnancy test negative and using an acceptable contraception method, except if postmenopausal for more than 2 years or sterilized for more than 3 months.