A Study to Evaluate Plasma Gelsolin in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Volunteers, Healthy

In brief

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.

Key facts

Study ID

NCT05789745

Run by

BioAegis Therapeutics Inc.

People needed

32

Starts

2023-03-14

Expected to finish

2023-05-24

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or female adults 18 to 55 years of age without chronic or active acute medical conditions
• Informed consent obtained from subject
• Weight ≤100 kg and body mass index (BMI) <30 kg/m2
• Willingness to use contraception during the course of the study, starting at screening and for at least 3 months after their final study treatment

You may not qualify if…

• Pregnant or lactating women
• Acute illness during the month prior to screening
• 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
• Hospitalization during the year prior to screening
• History of cancer or treatment with systemic chemotherapy or radiation therapy at any time
• Transplantation of hematopoietic or solid organs
• 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
• Receipt of blood products during the year prior to screening
• Chronic mechanical ventilation or dialysis
• Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator
• Any clinically significant abnormalities of vital signs, EKG or physical examination findings as judged by the Investigator
• Positive results for recreational drugs during screening
• Any other condition deemed by the Investigator as possibly interfering with the conduct of the study

Where it is running

• Nucleus Network — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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