Clinical trial: DAS181 Single Dose Escalation Study in Healthy Adults (NCT00876161)

Eligibility criteria:
Inclusion Criteria:

          -  Male and female subjects in generally good health in the opinion of the investigator
             as determined by vital signs, medical history, and a targeted physical exam based on
             medical history.

          -  Subjects must be able to verbalize understanding of the consent form, provide written
             informed consent and verbalize willingness to complete study procedures

          -  Be 18 to 65 years of age (inclusive), in the past 12 months.

          -  Subjects must weigh at least 50 kg and must have a Body Mass Index (BMI) of no greater
             than 35.

          -  No recent history of smoking in the past two years regardless of clinical relevance.

          -  No history of alcoholism or alcohol abuse regardless of clinical relevance.

          -  Electrocardiogram (ECG) with no clinically significant abnormalities recorded at
             screening visit: PR interval within 120 and 200 ms, QRS interval < 120 ms, and QTc
             interval ≤ 440 ms.

          -  Blood pressure within normal limits (systolic 90-140mmHg; diastolic 50-90 mmHg) and
             heart rate between 45 and 100 beats per minute.

          -  Chest X-ray and FEV1 results show no clinically significant abnormalities.

          -  Negative HIV, HBV, and HCV screening tests.

          -  Hemoglobin within provided range (see Appendix 2).

          -  White blood cell count and platelet count within provided range (see Appendix 2).

          -  Alkaline phosphatase (ALKP), total bilirubin, alanine aminotransferase (ALT),
             aspartate aminotransferase (AST), creatinine phosphokinase (CPK), within provided
             range (see Appendix 2).

          -  Serum glucose within provided range (see Appendix 2). If non-fasting glucose is
             abnormal, a fasting glucose measurement may be measured in its place. If this is
             within the provided range, then subject may be enrolled.

          -  Serum creatinine within provided range (see Appendix 2).

          -  Activated partial thromboplastin time (APTT), Fibrinogen within provided range (see
             Appendix 2).

          -  Urine glucose, protein, and hemoglobin tested by dipstick urinalysis are negative or
             not greater than trace. Menstruating females failing inclusion due to positive urine
             dipstick hemoglobin may be retested following cessation of menses.

          -  Female subjects must be post-menopausal (one year or greater without menses),
             surgically incapable of childbearing, or practicing an acceptable method of birth
             control. Acceptable methods may include intrauterine device, spermicide and barrier,
             abstinence and hormonal contraception. A female subject must agree to practice an
             acceptable method of birth control during study period and for 12 weeks after study
             terminates. She must have had a negative serum pregnancy test during the screening
             visit and a negative urine pregnancy test on the day of treatment prior to study drug
             dosing.

          -  If male, agrees to use medically accepted form of contraception from time of
             enrollment to 12 weeks after study termination

          -  Subjects must test negative for drugs and alcohol

        Exclusion Criteria:

          -  Have received any investigational drug or vaccine within 8 weeks prior to study drug
             dosing or have had a serious adverse reaction or hypersensitivity to any drug

          -  Have received blood products within 6 months of study enrollment

          -  Have been on a liquid protein diet in the last month.

          -  Are allergic or intolerant to lactose.

          -  Have sickle cell disease

          -  Have used prescription drugs, excluding hormonal contraception, within 7 days prior to
             admission (at the investigator's discretion) or non-prescription drugs (including
             herbal supplements) within 7 days prior to admission (at the investigator's
             discretion).

          -  Existence of any surgical, medical,or laboratory condition that, in the judgment of
             the clinical investigator, might interfere with the safety, distribution, metabolism
             or excretion of the drug

          -  Subjects with concurrent respiratory diseases (e.g., asthma, allergic rhinitis,
             chronic obstructive pulmonary disease, cystic fibrosis, or emphysema, anaphylaxis).

          -  Subjects who have experienced a previous episode of acute upper respiratory tract
             infection, pneumonia, otitis, bronchitis, or sinusitis within 2 weeks prior to
             screening.

          -  Subjects with concurrent sustained respiratory symptoms (running nose, sore throat,
             sneezing, coughing, or wheezing).

          -  Subjects who have an oral temperature above 37.8°C (100°F).

          -  Subjects with previous or current history of the following conditions: renal, hepatic,
             cardiac, pulmonary, hematologic, muscular, neurological, metabolic, or immunological
             disorders, hepatitis or cirrhosis, transplant recipients, HIV-infection, or other
             immunosuppressive illness.

          -  Subjects with cancer or history of hematologic malignancy. Cancer is defined as any
             active neoplastic diseases excluding noninvasive basal cell carcinoma.

          -  Subjects who have surgery within 30 days of initiation of the study.

          -  Female subjects who are pregnant or breast-feeding.

          -  Subjects who have donated or lost more than 500 mL of blood in the three months prior
             to screening.

          -  Subjects who have clinically significant medical or psychological conditions that
             would compromise the subject's safety, influence the results of the study, affect the
             subject's ability to participate in the study, or impair the subject's ability to
             provide informed consent.

          -  Subjects who have a history of drug dependence, or psychiatric illness within 2 years
             of study enrollment.
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 65 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? Contradiction