Trial Outcomes & Findings for Safety and Pharmacokinetics (PK) Study of Natrunix in Healthy Volunteers (NCT NCT05099510)
NCT ID: NCT05099510
Last Updated: 2026-08-14
Results Overview
Participants were monitored for treatment-emergent adverse events (TEAEs) immediately after the initial subcutaneous administration on Day 0 (Visit 1) through the final follow-up on Day 28 (Visit 7). All identified adverse events were documented and graded for severity according to the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials."
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
From Day 0 up to Day 28
Results posted on
2026-08-14
Participant Flow
Participants were recruited based on physician referral at a single research center.
Out of the 28 subjects that were screened, 24 were enrolled based on the eligibility criteria. Two subjects were screen failures while 2 withdrew consent prior to receiving the study drug.
Participant milestones
| Measure |
Cohort 1: Natrunix 100 mg
Participants received a single 100 mg subcutaneous dose of Natrunix followed by 4 weeks of follow-up.
|
Cohort 1: Placebo
Participants received a single 0.5 ml subcutaneous dose of placebo followed by 4 weeks of follow-up.
|
Cohort 2: Natrunix 200 mg
Participants received a single 200-mg subcutaneous dose of Natrunix followed by 4 weeks of follow-up.
|
Cohort 2: Placebo
Participants received a single 1 ml subcutaneous dose of placebo followed by 4 weeks of follow-up.
|
Cohort 3: Natrunix 400 mg
Participants received a single 400 mg subcutaneous dose of Natrunix followed by 4 weeks of follow-up.
|
Cohort 3: Placebo
Participants received a single 2 ml subcutaneous dose of placebo followed by 4 weeks of follow-up.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
6
|
2
|
6
|
2
|
|
Overall Study
COMPLETED
|
6
|
2
|
6
|
2
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Pharmacokinetics (PK) Study of Natrunix in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Cohort 1: Natrunix 100 mg
n=6 Participants
Participants received a single subcutaneous injection of 100 mg of Natrunix.
|
Cohort 1: Placebo 0.5 ml
n=2 Participants
Participant received a single 0.5 ml subcutaneous injection of placebo.
|
Cohort 2: Natrunix 200 mg
n=6 Participants
Participants received a single subcutaneous injection of 200 mg of Natrunix.
|
Cohort 2: Placebo 1 ml
n=2 Participants
Participant received a single 1 ml subcutaneous injection of placebo.
|
Cohort 3: Natrunix 400 mg
n=6 Participants
Participants received a single subcutaneous injection of 400 mg of Natrunix.
|
Cohort 3: Placebo 2 ml
n=2 Participants
Participants received a single 2 ml subcutaneous injection of placebo.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
1 Participants
n=83 Participants
|
0 Participants
n=84 Participants
|
1 Participants
n=286 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=11 Participants
|
2 Participants
n=11 Participants
|
6 Participants
n=22 Participants
|
2 Participants
n=255 Participants
|
5 Participants
n=83 Participants
|
2 Participants
n=84 Participants
|
23 Participants
n=286 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=286 Participants
|
|
Age, Continuous
|
24.5 years
n=11 Participants
|
27 years
n=11 Participants
|
31.5 years
n=22 Participants
|
28.5 years
n=255 Participants
|
31.5 years
n=83 Participants
|
32 years
n=84 Participants
|
29 years
n=286 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=11 Participants
|
2 Participants
n=11 Participants
|
4 Participants
n=22 Participants
|
1 Participants
n=255 Participants
|
3 Participants
n=83 Participants
|
2 Participants
n=84 Participants
|
16 Participants
n=286 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=255 Participants
|
3 Participants
n=83 Participants
|
0 Participants
n=84 Participants
|
8 Participants
n=286 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=11 Participants
|
1 Participants
n=11 Participants
|
3 Participants
n=22 Participants
|
1 Participants
n=255 Participants
|
5 Participants
n=83 Participants
|
0 Participants
n=84 Participants
|
12 Participants
n=286 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=11 Participants
|
1 Participants
n=11 Participants
|
3 Participants
n=22 Participants
|
1 Participants
n=255 Participants
|
1 Participants
n=83 Participants
|
2 Participants
n=84 Participants
|
12 Participants
n=286 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=286 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=286 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=11 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=255 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=84 Participants
|
6 Participants
n=286 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=286 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
3 Participants
n=83 Participants
|
0 Participants
n=84 Participants
|
6 Participants
n=286 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
4 Participants
n=22 Participants
|
1 Participants
n=255 Participants
|
2 Participants
n=83 Participants
|
2 Participants
n=84 Participants
|
11 Participants
n=286 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=286 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
1 Participants
n=83 Participants
|
0 Participants
n=84 Participants
|
1 Participants
n=286 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=11 Participants
|
2 participants
n=11 Participants
|
6 participants
n=22 Participants
|
2 participants
n=255 Participants
|
6 participants
n=83 Participants
|
2 participants
n=84 Participants
|
24 participants
n=286 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to Day 28Population: All participants who received a single subcutaneous dose of Natrunix.
Participants were monitored for treatment-emergent adverse events (TEAEs) immediately after the initial subcutaneous administration on Day 0 (Visit 1) through the final follow-up on Day 28 (Visit 7). All identified adverse events were documented and graded for severity according to the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials."
Outcome measures
| Measure |
Cohort 2: Natrunix 200 mg
n=2 Participants
Each participant received one single subcutaneous injection of 200 mg of Natrunix.
|
Cohort 3: Natrunix 400 mg
n=6 Participants
Each participant received one single subcutaneous injection of 400 mg of Natrunix.
|
Cohort 1: Natrunix 100 mg
n=6 Participants
Each participant received one single subcutaneous injection of 100 mg of Natrunix.
|
Cohort 2: Placebo 1 ml
n=2 Participants
Each participant received one single subcutaneous injection of placebo.
|
Cohort 3: Natrunix 400 mg
n=6 Participants
Each participant received one single subcutaneous injection of 400 mg of Natrunix.
|
Cohort 3: Placebo 2 ml
n=2 Participants
Each participant received one single subcutaneous injection of placebo.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Plasma samples were collected at the following intervals: Day 0: Pre-injection and at 3, 6, and 10 hours post-injection. Post-Injection Follow-up: Days 2, 3, 4, 14, and 28.Population: All participants who received a single subcutaneous dose of Natrunix and completed the study.
This outcome measure represents the peak exposure following a single subcutaneous administration of Natrunix. Cmax is assessed using a proprietary immunoassay. Placebo participants were not assessed for PK Outcome Measures
Outcome measures
| Measure |
Cohort 2: Natrunix 200 mg
n=6 Participants
Each participant received one single subcutaneous injection of 200 mg of Natrunix.
|
Cohort 3: Natrunix 400 mg
n=6 Participants
Each participant received one single subcutaneous injection of 400 mg of Natrunix.
|
Cohort 1: Natrunix 100 mg
n=6 Participants
Each participant received one single subcutaneous injection of 100 mg of Natrunix.
|
Cohort 2: Placebo 1 ml
Each participant received one single subcutaneous injection of placebo.
|
Cohort 3: Natrunix 400 mg
Each participant received one single subcutaneous injection of 400 mg of Natrunix.
|
Cohort 3: Placebo 2 ml
Each participant received one single subcutaneous injection of placebo.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
30.6 microgram/mL
Standard Error 4.3
|
59.9 microgram/mL
Standard Error 10.2
|
14.0 microgram/mL
Standard Error 2.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: All participants who received a single subcutaneous dose of Natrunix and completed the study.
This outcome measure evaluates the circulating drug levels at the end of the study observation period. Plasma samples were analyzed using a validated proprietary immunoassay to detect and quantify concentration levels of Natrunix. Placebo participants were not assessed for PK Outcome Measures
Outcome measures
| Measure |
Cohort 2: Natrunix 200 mg
n=6 Participants
Each participant received one single subcutaneous injection of 200 mg of Natrunix.
|
Cohort 3: Natrunix 400 mg
n=6 Participants
Each participant received one single subcutaneous injection of 400 mg of Natrunix.
|
Cohort 1: Natrunix 100 mg
n=6 Participants
Each participant received one single subcutaneous injection of 100 mg of Natrunix.
|
Cohort 2: Placebo 1 ml
Each participant received one single subcutaneous injection of placebo.
|
Cohort 3: Natrunix 400 mg
Each participant received one single subcutaneous injection of 400 mg of Natrunix.
|
Cohort 3: Placebo 2 ml
Each participant received one single subcutaneous injection of placebo.
|
|---|---|---|---|---|---|---|
|
Terminal Plasma Concentration
|
11.1 ug/mL
Standard Error 0.7
|
15.1 ug/mL
Standard Error 3.3
|
7.4 ug/mL
Standard Error 0.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Plasma samples were collected at the following intervals: Day 0: Pre-injection and at 3, 6, and 10 hours post-injection. Post-Injection Follow-up: Days 2, 3, 4, 14, and 28.Population: All participants who received a single subcutaneous dose of Natrunix and completed the study.
Half-life is calculated by Thermo-Scientific Kinetica Version 5.1 SP1, using average observed Natrunix plasma concentration of all time points of all patients for each treatment cohort. Placebo participants were not assessed for PK Outcome Measures
Outcome measures
| Measure |
Cohort 2: Natrunix 200 mg
n=6 Participants
Each participant received one single subcutaneous injection of 200 mg of Natrunix.
|
Cohort 3: Natrunix 400 mg
n=6 Participants
Each participant received one single subcutaneous injection of 400 mg of Natrunix.
|
Cohort 1: Natrunix 100 mg
n=6 Participants
Each participant received one single subcutaneous injection of 100 mg of Natrunix.
|
Cohort 2: Placebo 1 ml
Each participant received one single subcutaneous injection of placebo.
|
Cohort 3: Natrunix 400 mg
Each participant received one single subcutaneous injection of 400 mg of Natrunix.
|
Cohort 3: Placebo 2 ml
Each participant received one single subcutaneous injection of placebo.
|
|---|---|---|---|---|---|---|
|
Half-life
|
14.1 Days
Standard Error 0.8
|
8.1 Days
Standard Error 2.9
|
34.1 Days
Standard Error 9.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Plasma samples were collected at the following intervals: Day 0: Pre-injection and at 3, 6, and 10 hours post-injection. Post-Injection Follow-up: Days 2, 3, 4, 14, and 28.Population: All participants who received a single subcutaneous dose of Natrunix and completed the study.
This outcome measure calculates the area Under the Concentration-Time Curve (AUC) from the time of administration (Day 0) through the final observation point at Day 28. Placebo participants were not assessed for PK Outcome Measures
Outcome measures
| Measure |
Cohort 2: Natrunix 200 mg
n=6 Participants
Each participant received one single subcutaneous injection of 200 mg of Natrunix.
|
Cohort 3: Natrunix 400 mg
n=6 Participants
Each participant received one single subcutaneous injection of 400 mg of Natrunix.
|
Cohort 1: Natrunix 100 mg
n=6 Participants
Each participant received one single subcutaneous injection of 100 mg of Natrunix.
|
Cohort 2: Placebo 1 ml
Each participant received one single subcutaneous injection of placebo.
|
Cohort 3: Natrunix 400 mg
Each participant received one single subcutaneous injection of 400 mg of Natrunix.
|
Cohort 3: Placebo 2 ml
Each participant received one single subcutaneous injection of placebo.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve
|
539.6 ug*day/mL
Standard Error 73.0
|
945.3 ug*day/mL
Standard Error 163.3
|
288.6 ug*day/mL
Standard Error 38.0
|
—
|
—
|
—
|
Adverse Events
Cohort 1: 100 mg Natrunix
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: 200 mg Natrunix
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: 400 mg Natrunix
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: 100 mg Natrunix
n=6 participants at risk
Each participant received a single subcutaneous injection of 100 mg of Natrunix.
|
Cohort 1: Placebo
n=2 participants at risk
Each participant received a single subcutaneous injection of 0.5 ml of placebo.
|
Cohort 2: 200 mg Natrunix
n=6 participants at risk
Each participant received a single subcutaneous injection of 200 mg of Natrunix.
|
Cohort 2: Placebo
n=2 participants at risk
Each participant received a single subcutaneous injection of 1 ml of placebo.
|
Cohort 3: 400 mg Natrunix
n=6 participants at risk
Each participant received a single subcutaneous injection of 400 mg of Natrunix.
|
Cohort 3: Placebo
n=2 participants at risk
Each participant received a single subcutaneous injection of 2 ml of placebo.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/2 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/6 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/2 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/6 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/2 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/2 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/6 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/2 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/6 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/2 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
|
General disorders
Injection site bruising
|
0.00%
0/6 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/2 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
16.7%
1/6 • Number of events 1 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/2 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/6 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
0.00%
0/2 • Treatment emergent adverse events were monitored from Day 0 post- injection up to Day 28.
All untoward events occurring between visit 1 (Day 0 post- injection) and the end of study (28 days after the last injection of the treatment regimen or if the subject withdraws from the study early)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place