VolunteersPhase 1NCT05789745
A Study to Evaluate Plasma Gelsolin in Healthy Volunteers
A Phase 1 study testing Recombinant human plasma gelsolin in people with Volunteers and Healthy, run by BioAegis Therapeutics Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Volunteers, Healthy
- What is being tested?
- Recombinant human plasma gelsolin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to 24 May 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Recombinant human plasma gelsolin, placebo
- Keywords
- safety, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human plasma gelsolinDrug
intravenous administration of either 6, 12, 18, or 24 mg/kg at time 0, 12, 36, 60 and 84 hours
placeboOther
intravenous administration of saline control at time 0, 12, 36, 60 and 84 hours
| Study group | Role | What they receive |
|---|---|---|
| rhu-pGSN | Experimental | Treated with 5 doses of rhu-pGSN Receives: Drug: Recombinant human plasma gelsolin |
| normal saline | Placebo comparator | Treated with 5 doses of saline Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of subjects who had an Adverse Event
Measured: 28 days
Serious Adverse Events
Number of subjects who had a Serious Adverse Event
Measured: 28 days
Secondary outcomes (4)
Pharmacokinetics: pGSN Concentration
Concentration of pGSN at baseline, 12 hours after dose 1, and 24 hours after doses 2 and 5
Measured: 108 hours
Pharmacokinetics: pGSN Area Under the Curve (AUC)
Area Under the Curve (AUC) of pGSN concentration at 12 hours after dose 1, and 24 hours after doses 2 and 5
Measured: 108 hours
Pharmacokinetics: pGSN Half-life
Half-life of pGSN concentration 12 hours after dose 1, and 24 hours after doses 2 and 5
Measured: 108 hours
Presence of Anti-drug Antibodies
Number of participants who tested positive for anti-pGSN antibodies at baseline, and on day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start14 Mar 2023
- Primary completion24 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioAegis Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark J DiNubile, MD, Study director, BioAegis Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789745
- Sponsor's protocol ID
- BTI-101
- Status last verified
- May 2024
- First submitted
- 16 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05789745
- Acronym / sponsor ID
- BTI-101
- Conditions
- Volunteers, Healthy
- Keywords
- safety, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BioAegis Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 29 Mar 2023 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhu-pGSN | Experimental | Drug: Recombinant human plasma gelsolinTreated with 5 doses of rhu-pGSN |
| normal saline | Placebo comparator | Other: placeboTreated with 5 doses of saline |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human plasma gelsolinintravenous administration of either 6, 12, 18, or 24 mg/kg at time 0, 12, 36, 60 and 84 hours | Drug | rhu-pGSN |
| placebointravenous administration of saline control at time 0, 12, 36, 60 and 84 hours | Other | normal saline |
Primary outcome
Adverse Events
Time frame: 28 days
Number of subjects who had an Adverse Event
Serious Adverse Events
Time frame: 28 days
Number of subjects who had a Serious Adverse Event
4 secondary outcomes
Pharmacokinetics: pGSN Concentration
Time frame: 108 hours
Pharmacokinetics: pGSN Area Under the Curve (AUC)
Time frame: 108 hours
Pharmacokinetics: pGSN Half-life
Time frame: 108 hours
Presence of Anti-drug Antibodies
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J DiNubile, MD study director
BioAegis Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant human plasma gelsolin in people with Volunteers and Healthy, run by BioAegis Therapeutics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.