Trial Outcomes & Findings for Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) (NCT NCT04210375)
NCT ID: NCT04210375
Last Updated: 2025-07-09
Results Overview
All safety information is collected and evaluated.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Screening to 30 days
Results posted on
2025-07-09
Participant Flow
Participant milestones
| Measure |
JK07 - Cohort 1
Experimental: JK07 0.03 mg/kg
Cohort 1: Participants were administered 0.03 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
JK07: Recombinant fusion protein consisting of a fully humanized immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1
|
JK07 - Cohort 2
Experimental: JK07 0.09 mg/kg
Cohort 2: Participants were administered 0.09 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
JK07: Recombinant fusion protein consisting of a fully humanized immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1
|
JK07 - Cohort 3
Experimental: JK07 0.27 mg/kg
Cohort 3: Participants were administered 0.27 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
JK07: Recombinant fusion protein consisting of a fully humanized immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1
|
Matching Placebo
Matching Placebo: Vehicle control
Single dose of placebo administered by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
3
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
JK07 - Cohort 1
Experimental: JK07 0.03 mg/kg
Cohort 1: Participants were administered 0.03 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
JK07: Recombinant fusion protein consisting of a fully humanized immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1
|
JK07 - Cohort 2
Experimental: JK07 0.09 mg/kg
Cohort 2: Participants were administered 0.09 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
JK07: Recombinant fusion protein consisting of a fully humanized immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1
|
JK07 - Cohort 3
Experimental: JK07 0.27 mg/kg
Cohort 3: Participants were administered 0.27 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
JK07: Recombinant fusion protein consisting of a fully humanized immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1
|
Matching Placebo
Matching Placebo: Vehicle control
Single dose of placebo administered by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of JK07 in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
Baseline characteristics by cohort
| Measure |
JK07 - Cohort 1
n=4 Participants
Experimental: JK07 0.03 mg/kg
Cohort 1: Participants were administered 0.03 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 2
n=4 Participants
Experimental: JK07 0.09 mg/kg
Cohort 2: Participants were administered 0.09 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 3
n=3 Participants
Experimental: JK07 0.27 mg/kg
Cohort 3: Participants were administered 0.27 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
Matching Placebo
n=3 Participants
Matching Placebo: Vehicle control
Single dose of placebo administered by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
61.3 years
STANDARD_DEVIATION 9.74 • n=107 Participants
|
61.0 years
STANDARD_DEVIATION 14.93 • n=206 Participants
|
54.3 years
STANDARD_DEVIATION 5.13 • n=7 Participants
|
57.4 years
STANDARD_DEVIATION 10.14 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
14 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Screening to 30 daysPopulation: All randomized participants
All safety information is collected and evaluated.
Outcome measures
| Measure |
JK07 - Cohort 1
n=4 Participants
Experimental: JK07 0.03 mg/kg
Cohort 1: Participants were administered 0.03 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 2
n=4 Participants
Experimental: JK07 0.09 mg/kg
Cohort 2: Participants were administered 0.09 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 3
n=3 Participants
Experimental: JK07 0.27 mg/kg
Cohort 3: Participants were administered 0.27 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
Matching Placebo
n=3 Participants
Matching Placebo: Vehicle control
Single dose of placebo administered by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
|---|---|---|---|---|
|
Incidence and Severity of Treatment-emergent Adverse Events [Safety and Tolerability]
Treatment emergent AEs
|
4 number of events
|
3 number of events
|
8 number of events
|
2 number of events
|
|
Incidence and Severity of Treatment-emergent Adverse Events [Safety and Tolerability]
SAEs
|
0 number of events
|
0 number of events
|
1 number of events
|
0 number of events
|
SECONDARY outcome
Timeframe: Baseline to 60 daysPopulation: All randomized participants were included in the noncompartmental analysis of pharmacokinetic data.
Area under the concentration (time curve to the last quantifiable concentration) from blood samples taken on Days 1-4, and Days 7, 11, 15, 22, 30, and 60.
Outcome measures
| Measure |
JK07 - Cohort 1
n=4 Participants
Experimental: JK07 0.03 mg/kg
Cohort 1: Participants were administered 0.03 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 2
n=4 Participants
Experimental: JK07 0.09 mg/kg
Cohort 2: Participants were administered 0.09 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 3
n=3 Participants
Experimental: JK07 0.27 mg/kg
Cohort 3: Participants were administered 0.27 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
Matching Placebo
Matching Placebo: Vehicle control
Single dose of placebo administered by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
|---|---|---|---|---|
|
AUC(0-last) of JK07
|
5310 h*ng/mL
Geometric Coefficient of Variation 80.6
|
34400 h*ng/mL
Geometric Coefficient of Variation 2.9
|
139000 h*ng/mL
Geometric Coefficient of Variation 15.1
|
—
|
SECONDARY outcome
Timeframe: Baseline to 60 daysPopulation: All randomized participants were included in the noncompartmental analysis of pharmacokinetic data.
Maximum concentration from blood samples taken on Days 1-4, and Days 7, 11, 15, 22, 30, and 60.
Outcome measures
| Measure |
JK07 - Cohort 1
n=4 Participants
Experimental: JK07 0.03 mg/kg
Cohort 1: Participants were administered 0.03 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 2
n=4 Participants
Experimental: JK07 0.09 mg/kg
Cohort 2: Participants were administered 0.09 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 3
n=3 Participants
Experimental: JK07 0.27 mg/kg
Cohort 3: Participants were administered 0.27 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
Matching Placebo
Matching Placebo: Vehicle control
Single dose of placebo administered by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
|---|---|---|---|---|
|
Cmax of JK07
|
497 ng/mL
Geometric Coefficient of Variation 44.3
|
1680 ng/mL
Geometric Coefficient of Variation 20.9
|
5170 ng/mL
Geometric Coefficient of Variation 13.8
|
—
|
SECONDARY outcome
Timeframe: Baseline to 60 daysPopulation: All randomized participants were included in the noncompartmental analysis of pharmacokinetic data.
Half-life from blood samples taken on Days 1-4, and Days 7, 11, 15, 22, 30, and 60.
Outcome measures
| Measure |
JK07 - Cohort 1
n=4 Participants
Experimental: JK07 0.03 mg/kg
Cohort 1: Participants were administered 0.03 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 2
n=4 Participants
Experimental: JK07 0.09 mg/kg
Cohort 2: Participants were administered 0.09 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 3
n=3 Participants
Experimental: JK07 0.27 mg/kg
Cohort 3: Participants were administered 0.27 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
Matching Placebo
Matching Placebo: Vehicle control
Single dose of placebo administered by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
|---|---|---|---|---|
|
t1/2 of JK07
|
8.11 h
Geometric Coefficient of Variation 42.7
|
10.95 h
Geometric Coefficient of Variation 10.8
|
18.32 h
Geometric Coefficient of Variation 8.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening to 180 daysPopulation: All randomized participants.
2D-transthoracic echocardiography-derived LVEF
Outcome measures
| Measure |
JK07 - Cohort 1
n=4 Participants
Experimental: JK07 0.03 mg/kg
Cohort 1: Participants were administered 0.03 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 2
n=4 Participants
Experimental: JK07 0.09 mg/kg
Cohort 2: Participants were administered 0.09 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 3
n=3 Participants
Experimental: JK07 0.27 mg/kg
Cohort 3: Participants were administered 0.27 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
Matching Placebo
n=3 Participants
Matching Placebo: Vehicle control
Single dose of placebo administered by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
|---|---|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF)
Day 135
|
36 % of LVEF
Interval 22.0 to 46.0
|
31.7 % of LVEF
Interval 26.0 to 39.0
|
32 % of LVEF
Interval 27.0 to 37.0
|
22 % of LVEF
Interval 19.0 to 25.0
|
|
Left Ventricular Ejection Fraction (LVEF)
Day 180
|
36 % of LVEF
Interval 33.0 to 40.0
|
38.7 % of LVEF
Interval 30.0 to 52.0
|
32.3 % of LVEF
Interval 24.0 to 44.0
|
33.7 % of LVEF
Interval 31.0 to 36.0
|
|
Left Ventricular Ejection Fraction (LVEF)
Day 1 - pre dose
|
34 % of LVEF
Interval 29.0 to 36.0
|
28 % of LVEF
Interval 21.0 to 32.0
|
25 % of LVEF
Interval 17.0 to 37.0
|
31 % of LVEF
Interval 28.0 to 37.0
|
|
Left Ventricular Ejection Fraction (LVEF)
Day 1 - 6 hrs post dose
|
37 % of LVEF
Interval 34.0 to 39.0
|
30.5 % of LVEF
Interval 19.0 to 40.0
|
31 % of LVEF
Interval 23.0 to 35.0
|
33.7 % of LVEF
Interval 29.0 to 43.0
|
|
Left Ventricular Ejection Fraction (LVEF)
Day 2
|
39.8 % of LVEF
Interval 37.0 to 44.0
|
28.8 % of LVEF
Interval 21.0 to 41.0
|
30.7 % of LVEF
Interval 20.0 to 39.0
|
32.3 % of LVEF
Interval 32.0 to 33.0
|
|
Left Ventricular Ejection Fraction (LVEF)
Day 7
|
38.5 % of LVEF
Interval 29.0 to 51.0
|
33.5 % of LVEF
Interval 26.0 to 40.0
|
28 % of LVEF
Interval 21.0 to 37.0
|
27.3 % of LVEF
Interval 23.0 to 31.0
|
|
Left Ventricular Ejection Fraction (LVEF)
Day 15
|
42.5 % of LVEF
Interval 34.0 to 53.0
|
34.5 % of LVEF
Interval 28.0 to 40.0
|
28.3 % of LVEF
Interval 22.0 to 35.0
|
31 % of LVEF
Interval 27.0 to 38.0
|
|
Left Ventricular Ejection Fraction (LVEF)
Day 30
|
40.8 % of LVEF
Interval 33.0 to 49.0
|
33 % of LVEF
Interval 25.0 to 38.0
|
28.7 % of LVEF
Interval 20.0 to 38.0
|
32.7 % of LVEF
Interval 29.0 to 39.0
|
|
Left Ventricular Ejection Fraction (LVEF)
Day 60
|
38.5 % of LVEF
Interval 34.0 to 46.0
|
35.3 % of LVEF
Interval 28.0 to 44.0
|
30 % of LVEF
Interval 21.0 to 39.0
|
29.3 % of LVEF
Interval 22.0 to 33.0
|
|
Left Ventricular Ejection Fraction (LVEF)
Day 90
|
37 % of LVEF
Interval 30.0 to 51.0
|
36 % of LVEF
Interval 21.0 to 47.0
|
27 % of LVEF
Interval 16.0 to 39.0
|
25 % of LVEF
Interval 21.0 to 28.0
|
Adverse Events
JK07 - Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
JK07 - Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
JK07 - Cohort 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JK07 - Cohort 1
n=4 participants at risk
Experimental: JK07 0.03 mg/kg
Cohort 1: Participants were administered 0.03 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 2
n=4 participants at risk
Experimental: JK07 0.09 mg/kg
Cohort 2: Participants were administered 0.09 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 3
n=3 participants at risk
Experimental: JK07 0.27 mg/kg
Cohort 3: Participants were administered 0.27 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
Matching Placebo
n=3 participants at risk
Matching Placebo: Vehicle control
Single dose of placebo administered by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Upper Extremity Weakness
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
33.3%
1/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
Other adverse events
| Measure |
JK07 - Cohort 1
n=4 participants at risk
Experimental: JK07 0.03 mg/kg
Cohort 1: Participants were administered 0.03 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 2
n=4 participants at risk
Experimental: JK07 0.09 mg/kg
Cohort 2: Participants were administered 0.09 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
JK07 - Cohort 3
n=3 participants at risk
Experimental: JK07 0.27 mg/kg
Cohort 3: Participants were administered 0.27 mg/kg of JK07 single dose by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
Matching Placebo
n=3 participants at risk
Matching Placebo: Vehicle control
Single dose of placebo administered by intravenous infusion over 60 minutes, with 180 days of follow-up.
|
|---|---|---|---|---|
|
Nervous system disorders
Mild heahache
|
25.0%
1/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Nervous system disorders
Moderate Headache
|
25.0%
1/4 • Number of events 2 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Eye disorders
Change in vision
|
25.0%
1/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
25.0%
1/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Gastrointestinal disorders
Intermittent nausea
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
25.0%
1/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness in hips and left shoulder
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
25.0%
1/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
33.3%
1/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
33.3%
1/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Musculoskeletal and connective tissue disorders
Bilateral shoulder pain
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
33.3%
1/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
33.3%
1/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Nervous system disorders
Brachial neuritis of both upper extremities
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
33.3%
1/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Investigations
Elevated creatinine
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
33.3%
1/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia and arthralgia
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
33.3%
1/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Nervous system disorders
Neuropathy exacerbation
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
33.3%
1/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Investigations
Elevated liver enzymes
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
33.3%
1/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
|
Nervous system disorders
Left arm nerve pain
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/4 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
0.00%
0/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
33.3%
1/3 • Entire study duration (~180 days)
Subjects were observed for injection site reactions until Day 4 following IP administration, for DLAEs until Day 15 following IP administration, and for AEs and SAEs from the time of informed consent until 30 days after the IP administration. Following Day 30, only SAEs deemed at least possibly related to the study drug or study procedures were collected until the EOS visit (Day 180). AEs were graded using CTCAE v5.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60