A Study to Evaluate Plasma Gelsolin in Healthy Volunteers

NCT ID: NCT05789745

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2023-05-24

Brief 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.

Detailed Description

Doses will be administered at 0 hours (Day 1), 12 hours (Day 1), 36 hours (Day 2), 60 hours (Day 3), and 84 hours (Day 4). Subjects will be kept in-house until after the last blood sample is taken on Day 5. Subjects will return for follow-up 7 days after the initiation of therapy (Day 8) and on Day 28 for the End-of-Study (EOS) Visit. After each cohort has completed the Day 8 visit, review of the safety results (including labs) will be conducted (and unblinded where appropriate) before the initiation of the next higher dose cohort.

To assess safety and tolerability, subjects will undergo physical examinations (including vital sign measurements), adverse event (AE) assessments, concomitant medication assessments, and safety laboratory testing. Blood samples will be collected for analysis of pGSN levels and antibodies against pGSN.

Conditions

Volunteers; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

rhu-pGSN

Treated with 5 doses of rhu-pGSN

Group Type: EXPERIMENTAL

Recombinant human plasma gelsolin

Intervention Type: DRUG

intravenous administration of either 6, 12, 18, or 24 mg/kg at time 0, 12, 36, 60 and 84 hours

normal saline

Treated with 5 doses of saline

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

intravenous administration of saline control at time 0, 12, 36, 60 and 84 hours

Interventions

Recombinant human plasma gelsolin

intravenous administration of either 6, 12, 18, or 24 mg/kg at time 0, 12, 36, 60 and 84 hours

Intervention Type: DRUG

placebo

intravenous administration of saline control at time 0, 12, 36, 60 and 84 hours

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioAegis Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark J DiNubile, MD

Role: STUDY_DIRECTOR

BioAegis Therapeutics

Locations

Nucleus Network

Saint Paul, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BTI-101

Identifier Type: -

Identifier Source: org_study_id