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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-JW180095-A | Other Grant/Funding Number | United States Department of Defense | |
| 2020-006019-52 | EudraCT Number |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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To evaluate the intrapulmonary pharmacokinetics (PK), including epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations, of SPR206 as well as plasma concentrations of SPR206 in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPR206 | Experimental | Healthy subjects meeting eligibility criteria will receive a total of three 100 mg SPR206 intravenous doses administered every 8 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPR206 | Drug | Three 100 mg SPR206 intravenous doses administered every 8 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time 0 to 8 hours (AUC0-8) for ELF, AM, and plasma | 8 hours after the start of the third study drug IV infusion | |
| Maximum observed concentration (Cmax) for ELF, AM, and plasma | 8 hours after the start of the third study drug IV infusion | |
| Minimum concentration (Cmin) for ELF, AM, and plasma | 8 hours after the start of the third study drug IV infusion | |
| Time to the maximum observed concentration (Tmax) for ELF, AM, and plasma | 8 hours after the start of the third study drug IV infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | To assess the incidents of treatment-emergent adverse events following three 100mg SPR206 intravenous doses administered every 8 hours. AEs will be classified by System Organ Class (SOC) and Preferred Term (PT). Incidence, frequency, severity and duration will be presented. | Day -1 to Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, vascular or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant
Recent history (within 6 months) of known or suspected Clostridium difficile infection
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 Ab)
Positive testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening or prior to first dosing
Presence of the following symptoms at screening or within 28 days prior to screening or check-in (Day -1):
Close contact with anyone who tested positive for SARS-CoV-2 infection within 28 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 Check-In including:
History of substance abuse or alcohol abuse
Use of prescription medicine & tobacco/nicotine or marijuana-containing products
A female who is pregnant or breastfeeding
Other exclusion criteria per protocol
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| Name | Affiliation | Role |
|---|---|---|
| David Melnick, MD | Spero Therapeutics Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Facility | Manchester | M23 9QZ | United Kingdom |
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| Incidence of abnormal vital sign assessments - blood pressure |
To assess the incidents of abnormal systolic and diastolic blood pressure assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented. |
| Day -1 to Day 7 |
| Incidence of abnormal vital sign assessments - body temperature | To assess the incidents of abnormal body temperature assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented. | Day -1 to Day 7 |
| Incidence of abnormal vital sign assessments - heart rate | To assess the incidents of abnormal heart rate assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented. | Day -1 to Day 7 |
| Incidence of abnormal vital sign assessments - respiratory rate | To assess the incidents of abnormal respiratory rate assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency count of significant changes from baseline will be presented. | Day -1 to Day 7 |
| Incidence of abnormal physical exam assessments | To assess the incidents of abnormal body system assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Changes from baseline in physical examination findings will be classified as Normal, Abnormal NCS, and Abnormal CS. Frequency counts will be presented. | Day -1 to Day 7 |
| Incidence of abnormal ECG assessments - heart rate | To assess the incidents of abnormal heart rate assessment following three 100mg SPR206 intravenous doses administered every 8 hours. Cardiac (12-Lead ECG) for heart rate will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented. | Day -1 to Day 7 |
| Incidence of abnormal ECG assessments - PR, RR, QRS, QT and QTcF interval | To assess the incidents of abnormal PR interval, RR interval, QRS interval, QT interval and QTcF interval assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Cardiac (12-Lead ECG) results will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented. | Day -1 to Day 7 |
| Incidence of abnormal safety laboratory assessments | To assess the incidents of abnormal hematology, serum chemistry, coagulation and urinalysis assessments following three 100mg SPR206 intravenous doses administered every 8 hours. Frequency counts of significant changes from baseline will be presented. | Day -1 to Day 7 |