A Study to Evaluate Plasma Gelsolin in Healthy Volunteers

NCT05789745 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: BTI-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Volunteers; Healthy

Keywords

safety; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Number of subjects who had an Adverse Event

  28 days

• Serious Adverse Events

  Number of subjects who had a Serious Adverse Event

  28 days

Secondary Outcomes (4)

• Pharmacokinetics: pGSN Concentration

  108 hours

• Pharmacokinetics: pGSN Area Under the Curve (AUC)

  108 hours

• Pharmacokinetics: pGSN Half-life

  108 hours

• Presence of Anti-drug Antibodies

  28 days

Study Arms (2)

rhu-pGSN

EXPERIMENTAL

Treated with 5 doses of rhu-pGSN

Drug: Recombinant human plasma gelsolin

normal saline

PLACEBO COMPARATOR

Treated with 5 doses of saline

Other: placebo

Interventions

Recombinant human plasma gelsolin DRUG

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

rhu-pGSN

placebo OTHER

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

normal saline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• BioAegis Therapeutics Inc.: lead

Study Sites (1)

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Results Point of Contact

• Title: Trisha Shamp, Ph.D
• Organization: Nucleus Network

t.shamp@nucleusnetwork.com

651-641-2925

Study Officials

• Mark J DiNubile, MD

  BioAegis Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Doses prepared by unblinded pharmacist. Placebo and Drug are undistinguishable in syringe for administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: March 14, 2023
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)