Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Spero Therapeutics
With
Clinartis
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Adult males or female subjects, between 18 and 55 years of age (both inclusive) at the time of screening
BMI ≥ 18.5 and ≤ 32 (kg/m2) and weight between 55.0 and 100.0 kg (both inclusive)
Willing and able to provide written informed consent; Willing and able to comply with all study assessments and adhere to the protocol schedule
Medically healthy without clinically significant abnormalities as assessed by the Investigator based on screening medical history, physical examination, vital signs, 12-lead ECG, hematology, biochemistry and urinalysis
Have suitable venous access for blood sampling
You may not be if
History of seizure disorders
Positive urine drug, alcohol or cotinine testing at screening or check-in (Day -1)
Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV);
Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening;
Presence of the following symptoms at screening or within 14 days prior to screening or Check-in (Day -1)
1. Fever, chills or sweats (temperature of 38 °C / 100.4 °F or higher)
2. Difficulty breathing
3. Cough
4. Sore throat
5. New or recent loss of taste or smell
6. Nausea, vomiting or diarrhea;
Close contact with anyone who tested positive for SARS-CoV-2 infection within 14 days prior to screening or Check-in (Day -1);
Electrocardiogram (ECG) with QTcF interval duration equal or greater than 450 msec for males and 470 msec for females
Subjects who have any of the following abnormalities on laboratory values at screening or prior confinement including:
1. White blood cell count \< 3,000/mm3, hemoglobin \< 11g/dL;
3. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.5 x the upper limit of normal (ULN) for the reference laboratory;
History of substance abuse or alcohol abuse
Use of tobacco/nicotine- or marijuana-containing products (including vaping products) within 12 months prior to screening;
Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication
Clareo Health | Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers
