A Study to Evaluate Plasma Gelsolin in Healthy Volunteers

Healthy Clinical Trial

Official title:

Single-center, Randomized, Double-blind, Placebo-controlled, Ascending-Dose Study to Evaluate the Safety and Pharmacokinetics of Recombinant Human Plasma Gelsolin (Rhu-pGSN) After Intravenous Administration to Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05789745
• Other study ID #: BTI-101
• Status: Completed
• Phase: Phase 1
• Start date: March 14, 2023
• Est. completion date: May 24, 2023

Study information

• Verified date: June 2023
• Source: BioAegis Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Volunteers

Intervention

Drug:
• Recombinant human plasma gelsolin
intravenous administration of either 6, 12, 18, or 24 mg/kg at time 0, 12, 36, 60 and 84 hours

Other:
• placebo
intravenous administration of saline control at time 0, 12, 36, 60 and 84 hours

Locations

Country	Name	City	State
United States	Nucleus Network	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
BioAegis Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety -- SAE frequency	serious adverse events	28 days
Primary	Safety -- severe AE frequency	Grade 3/4 severe adverse events	28 days
Secondary	pharmacokinetics -- pGSN levels over time after dosing	pGSN levels	108 hours
Secondary	antidrug antibodies -- frequency before and 28 days post-dose	anti-pGSN antibodies	28 days