A Study to Evaluate Plasma Gelsolin in Healthy Volunteers
Sponsored by BioAegis Therapeutics Inc.
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 2 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. Healthy male or female adults 18 to 55 years of age without chronic or active acute medical conditions
2. Informed consent obtained from subject
3. Weight ≤100 kg and body mass index (BMI) <30 kg/m2
4. Willingness to use contraception during the course of the study, starting at screening and for at least 3 months after their final study treatment
Exclusion Criteria
1. Pregnant or lactating women
2. Acute illness during the month prior to screening
3. Circumstances that may require any medications (including prescription medication, over-the-counter medication, vitamins, or supplements) during the during the inpatient days of the study other than acetaminophen
4. Hospitalization during the year prior to screening
5. History of cancer or treatment with systemic chemotherapy or radiation therapy at any time
6. Transplantation of hematopoietic or solid organs
7. History of diabetes mellitus; myocardial infarction, angina, or other cardiovascular disease; stroke or cerebrovascular disease; chronic obstructive pulmonary disease (COPD) or asthma; deep vein thrombosis (DVT)/pulmonary embolism (PE); liver or kidney disease; clinically significant psychiatric condition; or active or chronic infection
8. Receipt of blood products during the year prior to screening
9. Chronic mechanical ventilation or dialysis
10. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator
11. Any clinically significant abnormalities of vital signs, EKG or physical examination findings as judged by the Investigator
12. Positive results for recreational drugs during screening
13. Any other condition deemed by the Investigator as possibly interfering with the conduct of the study