Clinical trial: Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults (NCT02788188)

Eligibility criteria:
-  INCLUSION CRITERIA:

               1. Age greater than or equal to 18 years and less than or equal to 60 years

               2. Body mass index (BMI) of 19-32 kg/m(2)

               3. Estimated glomerular filtration rate greater than or equal to 70 mL/min at
                  screening, calculated using the CKD-EPI formula

               4. Subjects must agree to:

          -  Not take any prescription or OTC medications with the exception of acetaminophen,
             ibuprofen, vitamins, seasonal allergy medications, and/or contraceptive medications
             for a period 7 days prior to study drug administration (i.e., Day 0)

             5. One of the following in order to avoid pregnancy:

          -  Females who are able to become pregnant (i.e., are not postmenopausal, have not
             undergone surgical sterilization, and are sexually active with men) must agree to use
             at least 2 effective forms of contraception from the date of the subject s signing of
             the informed consent form through 60 days after the last dose of study drug. At least
             one of the methods of contraception should be a barrier method.

          -  Males who have not undergone surgical sterilization and are sexually active with women
             must agree to use condoms plus have a partner use at least one additional effective
             form of contraception from the date of the subject s signing of the informed consent
             form through 60 days after the last dose of study drug.

        EXCLUSION CRITERIA:

          1. Any history of allergy, anaphylaxis, or severe reaction to beef products (including
             milk and gelatin)

          2. Any history of allergy, anaphylaxis, or severe reaction to IGIV or human blood
             products

          3. Any chronic medical problem that requires daily oral medications (except Tylenol,
             ibuprofen, oral contraceptives, vitamins, and seasonal allergy medications).

          4. History of cardiovascular disease, cardiomyopathy, heart failure, or unexplained
             syncope

          5. Subjects that have had confirmed MERS

          6. Women who are breast-feeding

          7. Positive urine or serum pregnancy test

          8. Abnormal chemistry panel

             -defined as any clinically significant baseline Grade 1 or greater toxicity, or any
             Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity
             table

             --evaluating only sodium (Na), potassium (K), serum bicarbonate (total CO2), blood
             urea nitrogen (BUN), creatinine, glucose, asp (ALT), aspartate aminotransferase (AST),
             total bilirubin, lactate dehydrogenase (LDH), and estimated glomerular filtration rate
             (GFR) by the CKD-EPI equation.

          9. Abnormal complete blood count (CBC)

             -defined as any clinically significant baseline Grade 1 or greater toxicity, or any
             Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity
             table--evaluating only the WBC (to include absolute neutrophil, lymphocyte, and
             eosinophil counts), hemoglobin, hematocrit, and platelets.

         10. Abnormal urinalysis

             -defined as any clinically significant baseline Grade 1 or greater
             toxicity--evaluating only protein, and RBCs

         11. Positive rheumatoid factor

         12. IgA deficiency (defined as IgA < 7 mg/dL)

         13. Participation in another research study with receipt of any investigational drug
             within 5 half-lives or 30 days, whichever is longer, prior to study drug
             administration (i.e., Day 0) and until completion of the study

         14. Participation in any other research study for 30 days after study drug administration

         15. Receipt of blood products within 2 months prior to study drug administration (i.e. Day
             0)

         16. Receipt of any vaccination within 30 days prior to study drug administration (i.e. Day
             0)

         17. Any acute or chronic condition that, in the opinion of the Investigator, would limit
             the subject s ability to complete and/or participate in this clinical study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Entailment