Trial Outcomes & Findings for Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody in Healthy Adults (NCT NCT06444048)
NCT ID: NCT06444048
Last Updated: 2026-05-04
Results Overview
Number of participants in each treatment group experiencing at least one solicited AE of any severity through 48 hours post-infusion
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Day 1 (post-infusion) through 48 hours post-infusion
Results posted on
2026-05-04
Participant Flow
The study population included healthy male and female adults, ages 18-49 years, inclusive, who met all eligibility criteria. Participants were enrolled between June 26, 2024 and December 3, 2024 and were recruited from the general population of the two participating Vaccine and Treatment Evaluation Unit (VTEU) sites.
Participant milestones
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
3 mg/kg single intravenous infusion of EV68-228-N.
EV68-228-N: EV68-228-N is a recombinant human monoclonal IgG1 antibody which is produced by genetically engineered plasmids in Nicotiana benthamiana. This intervention is directed against enterovirus EV-D68 capsid protein potentially providing treatments for EV-D68 infection and AMF.
|
Cohort 2 - 10 mg/kg EV68-228-N
10 mg/kg single intravenous infusion of EV68-228-N.
EV68-228-N: EV68-228-N is a recombinant human monoclonal IgG1 antibody which is produced by genetically engineered plasmids in Nicotiana benthamiana. This intervention is directed against enterovirus EV-D68 capsid protein potentially providing treatments for EV-D68 infection and AMF.
|
Cohort 3 - 30 mg/kg EV68-228-N
30 mg/kg single intravenous infusion of EV68-228-N.
EV68-228-N: EV68-228-N is a recombinant human monoclonal IgG1 antibody which is produced by genetically engineered plasmids in Nicotiana benthamiana. This intervention is directed against enterovirus EV-D68 capsid protein potentially providing treatments for EV-D68 infection and AMF.
|
Placebo
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
Placebo for EV68-228-N: The placebo is a sterile buffer solution formulated to match the EV68-228-N Drug Product. The formulation is 20mM Citrate + 10 mM Glycine, 8% Sucrose, and 0.01% Polysorbate 80, with a target pH of 5.5. The placebo was filled into glass vials at 10 mL per vial. The formulation buffer is a clear colorless liquid.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
6
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody in Healthy Adults
Baseline characteristics by cohort
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
n=6 Participants
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 10.1 • n=54 Participants
|
34.3 years
STANDARD_DEVIATION 7.3 • n=60 Participants
|
28.6 years
STANDARD_DEVIATION 6.6 • n=114 Participants
|
30.5 years
STANDARD_DEVIATION 6.8 • n=1 Participants
|
31.6 years
STANDARD_DEVIATION 7.9 • n=9 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
4 Participants
n=1 Participants
|
18 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
2 Participants
n=1 Participants
|
18 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
2 Participants
n=1 Participants
|
5 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=54 Participants
|
9 Participants
n=60 Participants
|
9 Participants
n=114 Participants
|
4 Participants
n=1 Participants
|
31 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=1 Participants
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
2 Participants
n=1 Participants
|
22 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
1 Participants
n=1 Participants
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
2 Participants
n=1 Participants
|
2 Participants
n=9 Participants
|
|
Body Mass Index (BMI)
|
23.33 kg/m^2
STANDARD_DEVIATION 3.97 • n=54 Participants
|
25.33 kg/m^2
STANDARD_DEVIATION 4.22 • n=60 Participants
|
23.47 kg/m^2
STANDARD_DEVIATION 1.98 • n=114 Participants
|
25.66 kg/m^2
STANDARD_DEVIATION 3.05 • n=1 Participants
|
24.31 kg/m^2
STANDARD_DEVIATION 3.47 • n=9 Participants
|
|
Height
|
173.63 cm
STANDARD_DEVIATION 12.65 • n=54 Participants
|
170.60 cm
STANDARD_DEVIATION 9.30 • n=60 Participants
|
174.53 cm
STANDARD_DEVIATION 9.90 • n=114 Participants
|
167.85 cm
STANDARD_DEVIATION 13.49 • n=1 Participants
|
172.08 cm
STANDARD_DEVIATION 10.98 • n=9 Participants
|
|
Weight
|
70.76 kg
STANDARD_DEVIATION 16.27 • n=54 Participants
|
73.67 kg
STANDARD_DEVIATION 13.99 • n=60 Participants
|
71.74 kg
STANDARD_DEVIATION 10.34 • n=114 Participants
|
72.30 kg
STANDARD_DEVIATION 11.49 • n=1 Participants
|
72.10 kg
STANDARD_DEVIATION 12.88 • n=9 Participants
|
PRIMARY outcome
Timeframe: Day 1 (post-infusion) through 48 hours post-infusionPopulation: The Safety population consists of all participants who received all or part of the study product.
Number of participants in each treatment group experiencing at least one solicited AE of any severity through 48 hours post-infusion
Outcome measures
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
n=6 Participants
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Solicited Adverse Events (AEs) Through 48 Hours Post-infusion
|
7 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 (post-infusion) through Day 29Population: The Safety population consists of all participants who received all or part of the study product.
Number of participants in each treatment group experiencing at least one unsolicited AE - including clinical and laboratory AEs - through Day 29
Outcome measures
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
n=6 Participants
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Unsolicited AEs - Including Clinical and Laboratory AEs - Through Day 29
|
2 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 1 (post-infusion) through Day 121Population: The Safety population consists of all participants who received all or part of the study product.
Number of participants in each treatment group experiencing at least one SAE, MAAE, or NOCMC through the end of the study.
Outcome measures
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
n=6 Participants
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Unsolicited Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs) Through the End of the Study
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Unsolicited Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs) Through the End of the Study
MAAE
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing Unsolicited Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs) Through the End of the Study
NOCMC
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Prior to infusion; end of infusion; 1, 3, 5, 24, and 48 hours after end of infusion; Days 8, 15, 29, 61, 91, and 121Population: The PK population consists of participants who received all or part of the study product who have at least one evaluable serum PK sample for the estimation of maximum observed serum concentration (Cmax) or area under the concentration-time curve from time 0 (time of infusion start, t=0 hours) to infinity (AUC0-infinity) and received a full dose. Participants receiving placebo are excluded from PK analysis.
Pharmacokinetics (PK) parameters were estimated from the EV68-228-N serum concentration-time data using Phoenix WinNonlin Non-compartmental analysis. AUC0-last is defined as the area under the concentration time-curve from time of infusion start (t=0 hours) to the last quantifiable concentration above the lower limit of quantitation (LLOQ)
Outcome measures
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 (Time of Infusion Start, t=0 Hours) to the Last Quantifiable Concentration (AUC0-last) of EV68-228-N in Serum
|
20800 µg*h/mL
Geometric Coefficient of Variation 17
|
86590 µg*h/mL
Geometric Coefficient of Variation 26
|
245200 µg*h/mL
Geometric Coefficient of Variation 21
|
—
|
SECONDARY outcome
Timeframe: Prior to infusion; end of infusion; 1, 3, 5, 24, and 48 hours after end of infusion; Days 8, 15, 29, 61, 91, and 121Population: The PK population consists of participants who received all or part of the study product who have at least one evaluable serum PK sample for the estimation of Cmax or AUC0-infinity and received a full dose. Participants receiving placebo are excluded from PK analysis.
PK parameters were estimated from the EV68-228-N serum concentration-time data using Phoenix WinNonlin Non-compartmental analysis. AUC0-infinity is defined as the area under the concentration time-curve from time of infusion start (t=0 hours) extrapolated to infinity based on the last observed concentration (Clast) and the elimination rate constant (lambda-z), where Clast is defined as the last observed positive concentration above the lower limit of quantitation (LLOQ) and lambda-z is defined as the first-order rate constant associated with the terminal (log-linear) portion of the concentration versus time curve describing the rate of elimination from serum. Estimated by linear regression of time vs. log concentration, AUC0-infinity was computed by adding AUC0-last to an area extrapolated by Clast divided by lambda-z.
Outcome measures
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 (Time of Infusion Start, t=0 Hours) to Infinity (AUC0-infinity) of EV68-228-N in Serum
|
21600 µg*h/mL
Geometric Coefficient of Variation 19
|
88850 µg*h/mL
Geometric Coefficient of Variation 25
|
251700 µg*h/mL
Geometric Coefficient of Variation 21
|
—
|
SECONDARY outcome
Timeframe: Prior to infusion; end of infusion; 1, 3, 5, 24, and 48 hours after end of infusionPopulation: The PK population consists of participants who received all or part of the study product who have at least one evaluable serum PK sample for the estimation of Cmax or AUC0-infinity and received a full dose. Participants receiving placebo are excluded from PK analysis.
PK parameters were estimated from the EV68-228-N serum concentration-time data using Phoenix WinNonlin Non-compartmental analysis. AUC0-48 is defined as the area under the concentration time-curve from time of infusion start (t=0 hours) to 48 hours post-infusion start.
Outcome measures
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 (Time of Infusion Start, t=0 Hours) to 48 Hours Post-dose (AUC0-48) of EV68-228-N in Serum
|
2435 µg*h/mL
Geometric Coefficient of Variation 16
|
9966 µg*h/mL
Geometric Coefficient of Variation 26
|
29440 µg*h/mL
Geometric Coefficient of Variation 25
|
—
|
SECONDARY outcome
Timeframe: Prior to infusion; end of infusion; 1, 3, 5, 24, and 48 hours after end of infusion; Days 8, 15, 29, 61, 91, and 121Population: The PK population consists of participants who received all or part of the study product who have at least one evaluable serum PK sample for the estimation of Cmax or AUC0-infinity and received a full dose. Participants receiving placebo are excluded from PK analysis.
PK parameters were estimated from the EV68-228-N serum concentration-time data using Phoenix WinNonlin Non-compartmental analysis. Cmax is defined as the maximum observed serum concentration.
Outcome measures
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of EV68-228-N in Serum
|
76.21 µg/mL
Geometric Coefficient of Variation 21
|
313.8 µg/mL
Geometric Coefficient of Variation 24
|
937.7 µg/mL
Geometric Coefficient of Variation 31
|
—
|
SECONDARY outcome
Timeframe: Prior to infusion; end of infusion; 1, 3, 5, 24, and 48 hours after end of infusion; Days 8, 15, 29, 61, 91, and 121Population: The PK population consists of participants who received all or part of the study product who have at least one evaluable serum PK sample for the estimation of Cmax or AUC0-infinity and received a full dose. Participants receiving placebo are excluded from PK analysis.
PK parameters were estimated from the EV68-228-N serum concentration-time data using Phoenix WinNonlin Non-compartmental analysis. Tmax is defined at the time of at which Cmax occurs. Because non-steady state data was collected, the entire curve was considered. If the maximum observed concentration was not unique, then the first maximum was used.
Outcome measures
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Time of Maximum Observed Serum Concentration (Tmax) of EV68-228-N in Serum
|
1.35 h
Interval 0.4 to 3.3
|
1.5 h
Interval 0.4 to 48.4
|
3.5 h
Interval 1.6 to 24.6
|
—
|
SECONDARY outcome
Timeframe: Prior to infusion; end of infusion; 1, 3, 5, 24, and 48 hours after end of infusion; Days 8, 15, 29, 61, 91, and 121Population: The PK population consists of participants who received all or part of the study product who have at least one evaluable serum PK sample for the estimation of Cmax or AUC0-infinity and received a full dose. Participants receiving placebo are excluded from PK analysis.
PK parameters were estimated from the EV68-228-N serum concentration-time data using Phoenix WinNonlin Non-compartmental analysis. t1/2 is defined as the time it takes serum concentrations to reduce by 50% during the terminal elimination phase and was estimated by the natural logarithm of 2 (ln(2)) divided by the elimination rate constant (lambda-z).
Outcome measures
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Apparent Terminal Elimination Half-life (t1/2) of EV68-228-N in Serum
|
601.75 h
Geometric Coefficient of Variation 11
|
588.42 h
Geometric Coefficient of Variation 17
|
611.52 h
Geometric Coefficient of Variation 19
|
—
|
SECONDARY outcome
Timeframe: Prior to infusion; end of infusion; 1, 3, 5, 24, and 48 hours after end of infusion; Days 8, 15, 29, 61, 91, and 121Population: The PK population consists of participants who received all or part of the study product who have at least one evaluable serum PK sample for the estimation of Cmax or AUC0-infinity and received a full dose. Participants receiving placebo are excluded from PK analysis.
PK parameters were estimated from the EV68-228-N serum concentration-time data using Phoenix WinNonlin Non-compartmental analysis. CL is defined as the total clearance and represents a volume that is cleared of the molecule of interest per hour. It was calculated as the dose divided by the area under the concentration-time curve from time 0 (time of infusion start, t=0 hours) to infinity (AUC0-infinity).
Outcome measures
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Total Clearance (CL) of EV68-228-N in Serum
|
0.139 mL/h/kg
Geometric Coefficient of Variation 19
|
0.112 mL/h/kg
Geometric Coefficient of Variation 25
|
0.120 mL/h/kg
Geometric Coefficient of Variation 21
|
—
|
SECONDARY outcome
Timeframe: Prior to infusion; end of infusion; 1, 3, 5, 24, and 48 hours after end of infusion; Days 8, 15, 29, 61, 91, and 121Population: The PK population consists of participants who received all or part of the study product who have at least one evaluable serum PK sample for the estimation of Cmax or AUC0-infinity and received a full dose. Participants receiving placebo are excluded from PK analysis.
PK parameters were estimated from the EV68-228-N serum concentration-time data using Phoenix WinNonlin Non-compartmental analysis. Vz is defined as the theoretical volume that the total amount of the molecule of interest would occupy if uniformly distributed at the concentration observed in serum. If the terminal phase was adequately captured, this value should approximate the volume of distribution at steady state and was calculated as the total clearance (CL) divided by elimination rate constant (lambda-z).
Outcome measures
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Volume of Distribution (Vz) of EV68-228-N in Serum During the Terminal Phase
|
120.61 mL/kg
Geometric Coefficient of Variation 12
|
95.48 mL/kg
Geometric Coefficient of Variation 32
|
105.18 mL/kg
Geometric Coefficient of Variation 27
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose), Days 8, 15, 29, 61, 91, and 121Population: The modified intent-to-treat population consists of participants who received at least a partial dose of study product and contributed both pre- and at least one post-dose venous blood sample for immunogenicity testing for which valid results were reported.
Anti-EV68-228-N antibodies were assessed utilizing a Meso Scale Discovery (MSD) Electrochemiluminescent (ECL) assay. Detectable anti-EV68-228-N is defined as having a positive screening MSD ECL assay result AND a positive confirmatory MSD ECL assay result.
Outcome measures
| Measure |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 Participants
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 Participants
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 Participants
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
n=6 Participants
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Number of Participants With Detectable Anti-EV68-228-N Antibodies in Serum
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Cohort 1 - 3 mg/kg EV68-228-N
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2 - 10 mg/kg EV68-228-N
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3 - 30 mg/kg EV68-228-N
Serious events: 0 serious events
Other events: 4 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 |
Cohort 1 - 3 mg/kg EV68-228-N
n=10 participants at risk
3 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 2 - 10 mg/kg EV68-228-N
n=10 participants at risk
10 mg/kg single intravenous infusion of EV68-228-N.
|
Cohort 3 - 30 mg/kg EV68-228-N
n=10 participants at risk
30 mg/kg single intravenous infusion of EV68-228-N.
|
Placebo
n=6 participants at risk
Placebo participants from Cohorts 1, 2, and 3. Placebo was administered by the same route as active drug.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
10.0%
1/10 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/6 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
General disorders
Fatigue
|
70.0%
7/10 • Number of events 7 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
20.0%
2/10 • Number of events 2 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
20.0%
2/10 • Number of events 2 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
50.0%
3/6 • Number of events 3 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
General disorders
Swelling
|
10.0%
1/10 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
10.0%
1/10 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/6 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
16.7%
1/6 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
10.0%
1/10 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/6 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
16.7%
1/6 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
16.7%
1/6 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
Investigations
Blood pressure increased
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
10.0%
1/10 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/6 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
2/10 • Number of events 2 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
10.0%
1/10 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/6 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Number of events 4 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
20.0%
2/10 • Number of events 2 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
20.0%
2/10 • Number of events 2 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
16.7%
1/6 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
10.0%
1/10 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/6 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
16.7%
1/6 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
10.0%
1/10 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/6 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/10 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
10.0%
1/10 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
10.0%
1/10 • Number of events 1 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
0.00%
0/6 • Solicited adverse events were collected from Day 1 (post-infusion) through 48 hours post-infusion. Unsolicited AEs, including clinical and laboratory events, were collected through Day 29. SAEs, NOCMCs, and MAAEs were collected through study follow-up (Day 121).
|
Additional Information
C. Buddy Creech, MD, MPH
Vanderbilt University Medical Center
Phone: 615-343-0332
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60