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A Study to Evaluate Plasma Gelsolin in Healthy Volunteers

Sponsored by BioAegis Therapeutics Inc.

About this trial

Last updated 2 years ago

Study ID

BTI-101

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

Yes

Accepting

18-75 Years
18 to 55 Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

Study BTI-101 is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation, parallel design study to evaluate the safety, tolerability, and pharmacokinetics of IV rhu-pGSN or saline placebo administered as 5 doses each of 6, 12, 18, or 24 mg/kg of body weight. Each of 4 dosing cohorts will include 8 subjects randomized 3:1 rhu-pGSN:placebo (6 rhu-pGSN subjects:2 placebo subjects). Subjects will be healthy adult volunteers 18-55 years of age.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status