Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Presidio Pharmaceuticals, Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy males
Age 18 to 55 years
Body mass index (BMI)18 to 32 kg/m2
Males, or females of non-childbearing potential
Age 18 to 65 years
Chronic hepatitis C, and absence of other known liver disease
Seropositive for HCV antibody (HCV Ab) or HCV RNA at least once previously
Seropositive for HCV Ab at screening
Serum HCV RNA \> 5 log10 IU/mL at screening
HCV gt-1
Treatment-naïve for hepatitis C:
BMI 18 to 35 kg/m2
Otherwise in good health, without severe or clinically significant chronic or recurrent conditions requiring frequent medical intervention or continual pharmacologic management, except for anti-hypertensive use
No medical or psychosocial conditions that would potentially interfere with the subject's ability to comply with the study assessments or visit schedule.
You may not be if
Seropositive for human immunodeficiency virus (HIV) antibody or hepatitis B virus (HBV) surface antigen (HBsAg)
Signs or symptoms of decompensated liver disease
Evidence of cirrhosis or hepatocellular carcinoma
Diabetes Mellitus treated with insulin or hypoglycemic agents
Asthma requiring hospital admission within the preceding 12 months
History of alcohol abuse or illicit drug use which could interfere with a patient's compliance with the protocol requirements
Any of the following laboratory values at screening
* Haemoglobin (Hgb) \<11 g/dL in women or 12 g/dL in men
* White blood cell count \<4,000/mm3
* Absolute neutrophil count (ANC) \< 1800 per mm3
* Platelet count \<100,000 per mm3
* Serum creatinine \> upper limit of normal (ULN) at the central study laboratory
* Serum albumin \<3.4 g/dL
* Total bilirubin \>2.0 mg/dL
Clinically significant abnormality in the electrocardiograms (ECGs) at screening
Clareo Health | A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients
