Trial Outcomes & Findings for A Phase 1a Study of PMN310 In Healthy Volunteers (NCT NCT06105528)
NCT ID: NCT06105528
Last Updated: 2025-07-25
Results Overview
Safety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
85 days
Results posted on
2025-07-25
Participant Flow
To evaluate the short-term safety and tolerability of PMN310, each cohort enrolled a sentinel group of 2 subjects who were dosed prior to dosing the remaining 6 subjects in the cohort (5:1, PMN310:placebo).A total of 129 subjects were screened, of whom, 40 subjects were randomized to treatment groups as follows: 6 subjects each in the PMN310 175 mg, 350 mg, 700 mg, 1400 mg, and 2800 mg groups and 2 subjects each in the matching placebo groups for these doses (10 subjects total received placebo).
Participant milestones
| Measure |
PMN310 175 mg
PMN310 175 mg single IV infusion
|
PMN310 350 mg
PMN310 350 mg single IV infusion
|
PMN310 700 mg
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
PMN310 2800 mg single IV infusion
|
Placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
Randomized Population
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
Safety Population
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
PK Population
|
6
|
6
|
6
|
6
|
6
|
2
|
|
Overall Study
Evaluable Population
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1a Study of PMN310 In Healthy Volunteers
Baseline characteristics by cohort
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
n=10 Participants
Placebo
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
38.50 Years
STANDARD_DEVIATION 10.407 • n=5 Participants
|
40.50 Years
STANDARD_DEVIATION 9.854 • n=7 Participants
|
46.17 Years
STANDARD_DEVIATION 8.589 • n=5 Participants
|
43.50 Years
STANDARD_DEVIATION 8.826 • n=4 Participants
|
41.67 Years
STANDARD_DEVIATION 9.730 • n=21 Participants
|
42.10 Years
STANDARD_DEVIATION 10.671 • n=8 Participants
|
42.08 Years
STANDARD_DEVIATION 9.458 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 85 daysSafety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events
Any Severity Grade 3 TEAE
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Incidence of Treatment Emergent Adverse Events
Any TESAE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Treatment Emergent Adverse Events
Any TEAE
|
2 participants
|
2 participants
|
0 participants
|
3 participants
|
3 participants
|
3 participants
|
|
Incidence of Treatment Emergent Adverse Events
Any TEAE Related to Study Treatment
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Incidence of Treatment Emergent Adverse Events
Any TEAE Leading to Treatment Discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 85 daysSafety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|---|---|---|---|
|
Incidence of Clinically Significant Abnormal Findings in Laboratory Assessments (Hematology, Serum Clinical Chemistry, and Urinalysis)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 85 daysSafety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|---|---|---|---|
|
Incidence of Clinically Significant Abnormal Findings in Physical Examinations Including Neurological Examinations
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 85 daysSafety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|---|---|---|---|
|
Incidence of Clinically Significant Abnormal Findings in Vital Signs (Supine Blood Pressure (BP), Pulse, Respiratory Rate and Oral Body Temperature)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 85 daysSafety and tolerability of PMN310 following a single intravenous dose in healthy subjects.
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|---|---|---|---|
|
Incidence of Clinically Significant Abnormal Findings in 12 Lead Electrocardiogram (ECG)
|
0 abnormal findings
|
0 abnormal findings
|
0 abnormal findings
|
0 abnormal findings
|
0 abnormal findings
|
0 abnormal findings
|
SECONDARY outcome
Timeframe: 0 to 2040 hours post-doseMeasure concentration of PMN310 in serum
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Summary of Serum Pharmacokinetic Parameters of PMN310 - AUCinf
|
19500000 h*ng/mL
Standard Deviation 2680000
|
54800000 h*ng/mL
Standard Deviation 24700000
|
91400000 h*ng/mL
Standard Deviation 17200000
|
17300000 h*ng/mL
Standard Deviation 26100000
|
417000000 h*ng/mL
Standard Deviation 78400000
|
—
|
SECONDARY outcome
Timeframe: Days 3 and 29Measure concentration of PMN310 in CSF
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Summary of CSF Concentrations of PMN310
Day 3
|
50.05 ng/mL
Standard Deviation 21.205
|
78.47 ng/mL
Standard Deviation 35.281
|
150.10 ng/mL
Standard Deviation 50.301
|
284.00 ng/mL
Standard Deviation 136.995
|
502.50 ng/mL
Standard Deviation 242.214
|
—
|
|
Summary of CSF Concentrations of PMN310
Day 29
|
32.43 ng/mL
Standard Deviation 27.276
|
37.20 ng/mL
Standard Deviation 19.916
|
92.80 ng/mL
Standard Deviation 45.787
|
134.43 ng/mL
Standard Deviation 71.353
|
241.00 ng/mL
Standard Deviation 111.366
|
—
|
SECONDARY outcome
Timeframe: 0 to 2040 hours post-doseMeasure concentration of PMN310 in serum
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Summary of Serum Pharmacokinetic Parameters of PMN310 - AUClast
|
18900000 h*ng/mL
Standard Deviation 2790000
|
49800000 h*ng/mL
Standard Deviation 19600000
|
86300000 h*ng/mL
Standard Deviation 16100000
|
16700000 h*ng/mL
Standard Deviation 2440000
|
40000000 h*ng/mL
Standard Deviation 71800000
|
—
|
SECONDARY outcome
Timeframe: 0 to 2040 hours post-doseMeasure concentration of PMN310 in serum
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Summary of Serum Pharmacokinetic Parameters of PMN310 - CL
|
0.00911 L/h
Standard Deviation 0.00112
|
0.00737 L/h
Standard Deviation 0.00281
|
0.00788 L/h
Standard Deviation 0.00141
|
0.00824 L/h
Standard Deviation 0.00134
|
0.00693 L/h
Standard Deviation 0.00139
|
—
|
SECONDARY outcome
Timeframe: 0 to 2040 hours post-doseMeasure concentration of PMN310 in serum
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Summary of Serum Pharmacokinetic Parameters of PMN310 - Cmax
|
88300 ng/mL
Standard Deviation 12800
|
350000 ng/mL
Standard Deviation 171000
|
337000 ng/mL
Standard Deviation 43600
|
704000 ng/mL
Standard Deviation 33800
|
1480000 ng/mL
Standard Deviation 201000
|
—
|
SECONDARY outcome
Timeframe: 0 to 2040 hours post-doseMeasure concentration of PMN310 in serum
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Summary of Serum Pharmacokinetic Parameters of PMN310 - T1/2
|
385.44 h
Standard Deviation 52.07
|
491.61 h
Standard Deviation 102.93
|
456.26 h
Standard Deviation 61.45
|
440.09 h
Standard Deviation 44.06
|
394.02 h
Standard Deviation 111.30
|
—
|
SECONDARY outcome
Timeframe: 0 to 2040 hours post-doseMeasure concentration of PMN310 in serum
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Summary of Serum Pharmacokinetic Parameters of PMN310 - Tmax
|
2.25 h
Interval 1.28 to 3.25
|
5.75 h
Interval 1.75 to 37.42
|
1.75 h
Interval 1.27 to 3.25
|
2.75 h
Interval 1.35 to 37.25
|
7.25 h
Interval 1.35 to 96.93
|
—
|
SECONDARY outcome
Timeframe: 0 to 2040 hours post-doseMeasure concentration of PMN310 in serum
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Summary of Serum Pharmacokinetic Parameters of PMN310 - Vd
|
5.08 L
Standard Deviation 1.08
|
5.08 L
Standard Deviation 1.96
|
5.22 L
Standard Deviation 0.735
|
5.17 L
Standard Deviation 0.419
|
4.32 L
Standard Deviation 0.805
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 85 daysPopulation: The number of subjects who developed detectable levels of anti-PMN310 antibodies following a single intravenous dose. Only subjects that were not confirmed ADA positive at Baseline were included in the overall tabulation.
The number of subjects who developed detectable levels of anti-PMN310 antibodies following a single intravenous dose
Outcome measures
| Measure |
PMN310 175 mg
n=6 Participants
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 Participants
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 Participants
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 Participants
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 Participants
PMN310 2800 mg single IV infusion
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|---|---|---|---|
|
Immunogenicity of PMN310 - Anti-drug Antibodies (ADAs) in Serum
Overall - ADAs, Positive
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Immunogenicity of PMN310 - Anti-drug Antibodies (ADAs) in Serum
Overall -ADAs, Negative
|
5 participants
|
3 participants
|
6 participants
|
6 participants
|
5 participants
|
9 participants
|
|
Immunogenicity of PMN310 - Anti-drug Antibodies (ADAs) in Serum
Day 85 - Screening Assay, Positive
|
1 participants
|
3 participants
|
2 participants
|
0 participants
|
1 participants
|
3 participants
|
|
Immunogenicity of PMN310 - Anti-drug Antibodies (ADAs) in Serum
Day 85 - Screening Assay, Negative
|
5 participants
|
3 participants
|
4 participants
|
6 participants
|
5 participants
|
7 participants
|
|
Immunogenicity of PMN310 - Anti-drug Antibodies (ADAs) in Serum
Day 85 - Confirmatory Assay, Positive
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Immunogenicity of PMN310 - Anti-drug Antibodies (ADAs) in Serum
Day 85 - Confirmatory Assay, Negative
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
Adverse Events
PMN310 175 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PMN310 350 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PMN310 700 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PMN310 1400 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PMN310 2800 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PMN310 175 mg
n=6 participants at risk
PMN310 175 mg single IV infusion
|
PMN310 350 mg
n=6 participants at risk
PMN310 350 mg single IV infusion
|
PMN310 700 mg
n=6 participants at risk
PMN310 700 mg single IV infusion
|
PMN310 1400 mg
n=6 participants at risk
PMN310 1400 mg single IV infusion
|
PMN310 2800 mg
n=6 participants at risk
PMN310 2800 mg single IV infusion
|
Placebo
n=10 participants at risk
Placebo
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Presyncope
|
16.7%
1/6 • Number of events 1 • 85 days
|
33.3%
2/6 • Number of events 3 • 85 days
|
0.00%
0/6 • 85 days
|
16.7%
1/6 • Number of events 1 • 85 days
|
0.00%
0/6 • 85 days
|
10.0%
1/10 • Number of events 1 • 85 days
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • 85 days
|
33.3%
2/6 • Number of events 3 • 85 days
|
0.00%
0/6 • 85 days
|
33.3%
2/6 • Number of events 2 • 85 days
|
0.00%
0/6 • 85 days
|
10.0%
1/10 • Number of events 2 • 85 days
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • 85 days
|
16.7%
1/6 • Number of events 1 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
10.0%
1/10 • Number of events 1 • 85 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
10.0%
1/10 • Number of events 1 • 85 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
10.0%
1/10 • Number of events 1 • 85 days
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
10.0%
1/10 • Number of events 1 • 85 days
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
16.7%
1/6 • Number of events 1 • 85 days
|
0.00%
0/10 • 85 days
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • 85 days
|
16.7%
1/6 • Number of events 1 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/10 • 85 days
|
|
Psychiatric disorders
Acute stress disorder
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
10.0%
1/10 • Number of events 1 • 85 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • 85 days
|
16.7%
1/6 • Number of events 1 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/10 • 85 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
1/6 • Number of events 1 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/10 • 85 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 2 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/10 • 85 days
|
|
General disorders
Application site hypersensitivity
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
16.7%
1/6 • Number of events 1 • 85 days
|
0.00%
0/10 • 85 days
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
16.7%
1/6 • Number of events 1 • 85 days
|
0.00%
0/10 • 85 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
10.0%
1/10 • Number of events 1 • 85 days
|
|
Surgical and medical procedures
Fracture treatment
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
0.00%
0/6 • 85 days
|
16.7%
1/6 • Number of events 1 • 85 days
|
0.00%
0/10 • 85 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place