Phase 1
N=32
A Study to Evaluate Plasma Gelsolin in Healthy Volunteers
Volunteers · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05789745 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Adverse Events — 1; 2; 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Recombinant human plasma gelsolin (Drug); placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioAegis Therapeutics Inc.
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
1; 2; 3; 2; 1 | — |
| PRIMARY Serious Adverse Events |
0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics: pGSN Concentration |
63.6; 61.2; 59.1; 71.8; 148.4; 347.5 | — |
| SECONDARY Pharmacokinetics: pGSN Area Under the Curve (AUC) |
1245.5; 2737.5; 3547.0; 4832.3; 3066.2; 6448.5 | — |
| SECONDARY Pharmacokinetics: pGSN Half-life |
14.0; 13.1; 9.2; 10.7; 16.7; 14.5 | — |
| SECONDARY Presence of Anti-drug Antibodies |
0; 0; 0; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05789745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.