CompletedNCT05789745Updated Sep 19, 2024Results posted

A Study to Evaluate Plasma Gelsolin in Healthy Volunteers

A Phase 1 interventional study of Recombinant human plasma gelsolin and placebo in Volunteers and Healthy, sponsored by BioAegis Therapeutics Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by BioAegis Therapeutics Inc. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 32
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

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 studied

Volunteers
Healthy

Keywords

safety
pharmacokinetics

In context

Lead sponsor

BioAegis Therapeutics Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy male or female adults 18 to 55 years of age without chronic or active acute medical conditions
obtained from subject
Weight ≤100 kg and (BMI) \<30 kg/m2
Willingness to use during the course of the study, starting at screening and for at least 3 months after their final study treatment

Exclusion criteria

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; (COPD) or asthma; deep vein thrombosis (DVT)/pulmonary embolism (PE); liver or kidney disease; 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, 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

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 32 participants (actual)

Study arms

Experimental
rhu-pGSN
Treated with 5 doses of rhu-pGSN
Drug: Recombinant human plasma gelsolin
Placebo comparator
normal saline
Treated with 5 doses of saline
Other: placebo

Interventions

DrugRecombinant human plasma gelsolin
intravenous administration of either 6, 12, 18, or 24 mg/kg at time 0, 12, 36, 60 and 84 hours
Otherplacebo
intravenous administration of saline control at time 0, 12, 36, 60 and 84 hours

What researchers measure

Primary outcomes

Adverse Events
Number of subjects who had an Adverse Event
Time frame: 28 days
Serious Adverse Events
Number of subjects who had a Serious Adverse Event
Time frame: 28 days

Secondary outcomes

Pharmacokinetics: pGSN Concentration
Concentration of pGSN at baseline, 12 hours after dose 1, and 24 hours after doses 2 and 5
Time frame: 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
Time frame: 108 hours
Pharmacokinetics: pGSN Half-life
Half-life of pGSN concentration 12 hours after dose 1, and 24 hours after doses 2 and 5
Time frame: 108 hours
Presence of Anti-drug Antibodies
Number of participants who tested positive for anti-pGSN antibodies at baseline, and on day 28
Time frame: 28 days

Results

Posted Sep 19, 2024

Participant flow

Participant flow — Overall Study
Milestone	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)	Placebo Cohorts 1-4
Started	6	6	6	6	8
Completed	6	6	6	6	7
Not completed	0	0	0	0	1
Withdrew: Withdrawal by subject	0	0	0	0	1

Outcome measures

PrimaryAdverse Events

Number of subjects who had an Adverse Event

Time frame:: 28 days
Reported as:: Count of participants · Participants

Adverse Events
Participants	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)	Placebo Cohorts 1-4
Adverse Events	1	2	3	2	1

PrimarySerious Adverse Events

Number of subjects who had a Serious Adverse Event

Time frame:: 28 days
Reported as:: Count of participants · Participants

Serious Adverse Events
Participants	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)	Placebo Cohorts 1-4
Serious Adverse Events	0	0	0	0	0

SecondaryPharmacokinetics: pGSN Concentration

Concentration of pGSN at baseline, 12 hours after dose 1, and 24 hours after doses 2 and 5

Time frame:: 108 hours
Reported as:: Geometric mean · micrograms/mL

Pharmacokinetics: pGSN Concentration
micrograms/mL	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)
Baseline	63.6 ± 13.2	61.2 ± 19.7	59.1 ± 8.8	71.8 ± 11.1
Cmax (Dose 1)	148.4 ± 26.8	347.5 ± 41.2	442.5 ± 50.2	663.6 ± 110.8
Cmax (Dose 2)	225.2 ± 27.0	506.9 ± 78.5	691.5 ± 110.5	855.7 ± 200.6
Cmax (Dose 5)	218.9 ± 37.7	501.6 ± 60.4	703.8 ± 140.7	970.9 ± 87.9

SecondaryPharmacokinetics: 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

Time frame:: 108 hours
Reported as:: Geometric mean · hours*(micrograms/mL)

Pharmacokinetics: pGSN Area Under the Curve (AUC)
hours*(micrograms/mL)	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)
AUC0-12 (dose 1)	1245.5 ± 257.9	2737.5 ± 379.1	3547.0 ± 657.3	4832.3 ± 646.6
AUC0-24 (dose 2)	3066.2 ± 256.8	6448.5 ± 599.5	9374.2 ± 2456.0	10258.2 ± 2035.6
AUC0-24 (dose 5)	3486.5 ± 1035.2	6599.1 ± 1334.2	9139.1 ± 793.1	12135.3 ± 1172.4

SecondaryPharmacokinetics: pGSN Half-life

Half-life of pGSN concentration 12 hours after dose 1, and 24 hours after doses 2 and 5

Time frame:: 108 hours
Reported as:: Geometric mean · hours

Pharmacokinetics: pGSN Half-life
hours	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)
t1/2 (dose 1)	14.0 ± 5.4	13.1 ± 2.6	9.2 ± 3.0	10.7 ± 5.2
t1/2 (dose 2)	16.7 ± 6.1	14.5 ± 3.4	15.1 ± 4.5	12.0 ± 1.5
t1/2 (dose 5)	28.4 ± 8.5	22.0 ± 11.3	17.6 ± 1.9	14.5 ± 2.2

SecondaryPresence of Anti-drug Antibodies

Number of participants who tested positive for anti-pGSN antibodies at baseline, and on day 28

Time frame:: 28 days
Reported as:: Count of participants · Participants

Presence of Anti-drug Antibodies
Participants	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)	Placebo Cohorts 1-4
Baseline	0	0	0	0	0
Day 28	0	0	0	1	1

Adverse events

Collected over From the first study intervention to 4 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1 (6 mg/kg)	0/6 (0%)	0/6 (0%)	1/6 (16.7%)
Cohort 2 (12 mg/kg)	0/6 (0%)	0/6 (0%)	2/6 (33.3%)
Cohort 3 (18 mg/kg)	0/6 (0%)	0/6 (0%)	3/6 (50%)
Cohort 4 (24 mg/kg)	0/6 (0%)	0/6 (0%)	2/6 (33.3%)
Placebo Cohorts 1-4	0/8 (0%)	0/8 (0%)	1/8 (12.5%)

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)	Placebo Cohorts 1-4
DermatitisSkin and subcutaneous tissue disorders	0/6	0/6	0/6	1/6	0/8
EcchymosisSkin and subcutaneous tissue disorders	0/6	1/6	0/6	0/6	0/8
RashSkin and subcutaneous tissue disorders	0/6	0/6	1/6	0/6	0/8
ConstipationGastrointestinal disorders	0/6	0/6	1/6	0/6	0/8
Epigastric discomfortGastrointestinal disorders	0/6	0/6	0/6	1/6	0/8
Muscle contractions involuntaryNervous system disorders	0/6	1/6	0/6	0/6	0/8
FatigueGeneral disorders	0/6	0/6	1/6	0/6	0/8
Urinary tract infectionInfections and infestations	0/6	1/6	0/6	0/6	0/8
Muscle strainInjury, poisoning and procedural complications	1/6	0/6	0/6	0/6	0/8
ArthralgiaMusculoskeletal and connective tissue disorders	0/6	0/6	1/6	0/6	0/8

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)	Placebo Cohorts 1-4	Total
Mean	35.3 ± 10.23	42.2 ± 4.07	37.7 ± 14.68	37.0 ± 15.44	30.5 ± 7.37	36.2 ± 11.00

Age, Continuous
Age, Continuous(years)	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)	Placebo Cohorts 1-4	Total
Median	34.0 (25 to 54)	41.5 (38 to 48)	36.0 (20 to 55)	37.5 (20 to 52)	28.5 (21 to 43)	36.5 (20 to 55)

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)	Placebo Cohorts 1-4	Total
Female	2	3	3	3	1	12
Male	4	3	3	3	7	20

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)	Placebo Cohorts 1-4	Total
Hispanic or Latino	2	1	0	1	1	5
Not Hispanic or Latino	4	5	6	5	7	27
Unknown or Not Reported	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)	Placebo Cohorts 1-4	Total
American Indian or Alaska Native	0	0	0	0	0	0
Asian	0	0	1	3	0	4
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	1	1	0	0	2	4
White	5	5	5	3	6	24
More than one race	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0

BMI
BMI(kg/m^2)	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)	Placebo Cohorts 1-4	Total
Mean	24.55 ± 2.899	24.77 ± 3.506	25.28 ± 3.722	25.43 ± 2.876	23.85 ± 2.021	24.72 ± 2.862

BMI
BMI(kg/m^2)	Cohort 1 (6 mg/kg)	Cohort 2 (12 mg/kg)	Cohort 3 (18 mg/kg)	Cohort 4 (24 mg/kg)	Placebo Cohorts 1-4	Total
Median	24.50 (19.5 to 27.9)	24.65 (20.8 to 28.8)	26.60 (19.0 to 29.7)	25.95 (21.9 to 29.1)	23.85 (21.2 to 26.4)	24.75 (19.0 to 29.7)

Study locations

1 site

Nucleus Network
Saint Paul, Minnesota 55114, United States

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Jan 10, 2023

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05789745
Lead sponsor: BioAegis Therapeutics Inc.
Responsible party: Sponsor
First posted: Mar 29, 2023
Start date: Mar 14, 2023
Primary completion: May 24, 2023
Completion: May 24, 2023
Results posted: Sep 19, 2024
Last update: Sep 19, 2024

Study contacts

Mark J DiNubile, MD

study director · BioAegis Therapeutics

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

BioAegis Therapeutics Inc.

Start the discussion