Trial Outcomes & Findings for RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers (NCT NCT04700163)
NCT ID: NCT04700163
Last Updated: 2025-03-13
Results Overview
The number of participants with treatment-related solicited and unsolicited grade 2 adverse events (including confirmed laboratory abnormalities).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-03-13
Participant Flow
Participants were screened for participation and screened out if did not meet eligibility criteria. Participants enrolled sequentially in the study, following a dose escalation scheme as per protocol.
Participant milestones
| Measure |
S1 - Low Dose
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S2 - Mid Dose
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V1 - Low Dose
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V2 - Mid Dose
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V3 - High Dose
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S3 - Open Label
200 mg of C144-LS and 200 mg of C135-LS or placebo, subcutaneously.
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
8
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
S1 - Low Dose
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S2 - Mid Dose
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V1 - Low Dose
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V2 - Mid Dose
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V3 - High Dose
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S3 - Open Label
200 mg of C144-LS and 200 mg of C135-LS or placebo, subcutaneously.
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
S1 - Low Dose
n=3 Participants
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S2 - Mid Dose
n=3 Participants
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V1 - Low Dose
n=3 Participants
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V2 - Mid Dose
n=3 Participants
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V3 - High Dose
n=3 Participants
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S3 - Open Label
n=8 Participants
200 mg of C144-LS and 200 mg of C135-LS or placebo, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
42 years
n=5 Participants
|
39 years
n=7 Participants
|
39 years
n=5 Participants
|
52 years
n=4 Participants
|
54 years
n=21 Participants
|
38 years
n=8 Participants
|
44 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
8 participants
n=8 Participants
|
23 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 4 weeksThe number of participants with treatment-related solicited and unsolicited grade 2 adverse events (including confirmed laboratory abnormalities).
Outcome measures
| Measure |
V3 - High Dose
n=3 Participants
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S3 - Open Label
n=8 Participants
200 mg of C144-LS and 200 mg of C135-LS or placebo, subcutaneously.
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S1 - Low Dose
n=3 Participants
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S2 - Mid Dose
n=3 Participants
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V1 - Low Dose
n=3 Participants
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V2 - Mid Dose
n=3 Participants
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
|---|---|---|---|---|---|---|
|
Grade 2 and Higher Adverse Events 4 Weeks After Administration.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 weeksThe number of participants with treatment-related solicited and unsolicited grade 3 adverse events (including confirmed laboratory abnormalities).
Outcome measures
| Measure |
V3 - High Dose
n=3 Participants
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S3 - Open Label
n=8 Participants
200 mg of C144-LS and 200 mg of C135-LS or placebo, subcutaneously.
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S1 - Low Dose
n=3 Participants
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S2 - Mid Dose
n=3 Participants
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V1 - Low Dose
n=3 Participants
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V2 - Mid Dose
n=3 Participants
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
|---|---|---|---|---|---|---|
|
Grade 3 and Higher Adverse Events 4 Weeks After Administration.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 48 weeksThe number of participants with treatment-related solicited serious adverse events.
Outcome measures
| Measure |
V3 - High Dose
n=3 Participants
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S3 - Open Label
n=8 Participants
200 mg of C144-LS and 200 mg of C135-LS or placebo, subcutaneously.
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S1 - Low Dose
n=3 Participants
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S2 - Mid Dose
n=3 Participants
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V1 - Low Dose
n=3 Participants
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V2 - Mid Dose
n=3 Participants
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
|---|---|---|---|---|---|---|
|
Related Serious Adverse Events (SAEs) Throughout the Study Period
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 48 weeksHalf-life of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
Outcome measures
| Measure |
V3 - High Dose
n=3 Participants
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S3 - Open Label
n=7 Participants
200 mg of C144-LS and 200 mg of C135-LS or placebo, subcutaneously.
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S1 - Low Dose
n=3 Participants
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S2 - Mid Dose
n=3 Participants
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V1 - Low Dose
n=3 Participants
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V2 - Mid Dose
n=3 Participants
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
|---|---|---|---|---|---|---|
|
Elimination Half-life (t1/2) of C135-LS and C144-LS
C135-LS Half-life
|
96.24 days
Standard Deviation 13.56
|
89.55 days
Standard Deviation 17.06
|
79.85 days
Standard Deviation 10.84
|
89.55 days
Standard Deviation 17.06
|
90.79 days
Standard Deviation 15.11
|
91.91 days
Standard Deviation 12.57
|
|
Elimination Half-life (t1/2) of C135-LS and C144-LS
C144-LS Half-life
|
103.5 days
Standard Deviation 14.10
|
107.3 days
Standard Deviation 29.2
|
80.96 days
Standard Deviation 14.58
|
107.3 days
Standard Deviation 29.21
|
96.37 days
Standard Deviation 11.48
|
114.4 days
Standard Deviation 3.444
|
PRIMARY outcome
Timeframe: 48 weeksClearance rate of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
Outcome measures
| Measure |
V3 - High Dose
n=3 Participants
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S3 - Open Label
n=6 Participants
200 mg of C144-LS and 200 mg of C135-LS or placebo, subcutaneously.
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S1 - Low Dose
n=3 Participants
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S2 - Mid Dose
n=3 Participants
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V1 - Low Dose
n=3 Participants
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V2 - Mid Dose
n=3 Participants
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
|---|---|---|---|---|---|---|
|
Clearance Rate of C135-LS and C144-LS
C135-LS Clearance
|
62.75 ml/day
Geometric Coefficient of Variation 19.56
|
70.58 ml/day
Geometric Coefficient of Variation 22.81
|
75.34 ml/day
Geometric Coefficient of Variation 33.54
|
70.58 ml/day
Geometric Coefficient of Variation 22.81
|
53.13 ml/day
Geometric Coefficient of Variation 19.61
|
70.88 ml/day
Geometric Coefficient of Variation 13.89
|
|
Clearance Rate of C135-LS and C144-LS
C144-LS Clearance
|
44.86 ml/day
Geometric Coefficient of Variation 6.584
|
61.43 ml/day
Geometric Coefficient of Variation 16.70
|
61.54 ml/day
Geometric Coefficient of Variation 7.105
|
61.43 ml/day
Geometric Coefficient of Variation 16.70
|
35.34 ml/day
Geometric Coefficient of Variation 26.85
|
50.96 ml/day
Geometric Coefficient of Variation 7.965
|
PRIMARY outcome
Timeframe: 48 weeksArea under the curve of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
Outcome measures
| Measure |
V3 - High Dose
n=3 Participants
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S3 - Open Label
n=6 Participants
200 mg of C144-LS and 200 mg of C135-LS or placebo, subcutaneously.
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S1 - Low Dose
n=3 Participants
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S2 - Mid Dose
n=3 Participants
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V1 - Low Dose
n=3 Participants
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V2 - Mid Dose
n=3 Participants
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
|---|---|---|---|---|---|---|
|
Area Under the Curve of C135-LS and C144-LS
C135-LS AUC
|
19626 (micrograms x day)/ml
Geometric Coefficient of Variation 6.464
|
2833 (micrograms x day)/ml
Geometric Coefficient of Variation 22.81
|
1327 (micrograms x day)/ml
Geometric Coefficient of Variation 33.54
|
2833 (micrograms x day)/ml
Geometric Coefficient of Variation 22.81
|
1873 (micrograms x day)/ml
Geometric Coefficient of Variation 6.6
|
6213 (micrograms x day)/ml
Geometric Coefficient of Variation 27.92
|
|
Area Under the Curve of C135-LS and C144-LS
C144-LS AUC
|
27452 (micrograms x day)/ml
Geometric Coefficient of Variation 3.205
|
3256 (micrograms x day)/ml
Geometric Coefficient of Variation 16.79
|
1625 (micrograms x day)/ml
Geometric Coefficient of Variation 35.03
|
3256 (micrograms x day)/ml
Geometric Coefficient of Variation 16.79
|
2816 (micrograms x day)/ml
Geometric Coefficient of Variation 13.42
|
8641 (micrograms x day)/ml
Geometric Coefficient of Variation 31.4
|
SECONDARY outcome
Timeframe: 48 weeksThe number of participants with treatment-related adverse events
Outcome measures
| Measure |
V3 - High Dose
n=3 Participants
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S3 - Open Label
n=8 Participants
200 mg of C144-LS and 200 mg of C135-LS or placebo, subcutaneously.
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S1 - Low Dose
n=3 Participants
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S2 - Mid Dose
n=3 Participants
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V1 - Low Dose
n=3 Participants
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V2 - Mid Dose
n=3 Participants
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
|---|---|---|---|---|---|---|
|
Investigational Product (IP)-Related Adverse Events During Study Follow up.
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 weeksProportion of individuals with treatment-induced anti-drug antibodies against each mAb and magnitude of the response
Outcome measures
| Measure |
V3 - High Dose
n=3 Participants
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S3 - Open Label
n=6 Participants
200 mg of C144-LS and 200 mg of C135-LS or placebo, subcutaneously.
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S1 - Low Dose
n=3 Participants
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S2 - Mid Dose
n=3 Participants
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V1 - Low Dose
n=3 Participants
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V2 - Mid Dose
n=3 Participants
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
|---|---|---|---|---|---|---|
|
Anti-C144-LS and Anti-C135-LS Antibodies in All Study Groups.
C135-LS ADA
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Anti-C144-LS and Anti-C135-LS Antibodies in All Study Groups.
C144-LS ADA
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
S1 - Low Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
S2 - Mid Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
V1 - Low Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
V2 - Mid Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
V3 - High Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
S3 - Open Label
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
S1 - Low Dose
n=3 participants at risk
100 mg of C144-LS and 100 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S2 - Mid Dose
n=3 participants at risk
200 mg of C144-LS and 200 mg of C135-LS, subcutaneously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V1 - Low Dose
n=3 participants at risk
1.5 mg/kg of C144-LS and 1.5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V2 - Mid Dose
n=3 participants at risk
5 mg/kg of C144-LS and 5 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
V3 - High Dose
n=3 participants at risk
15 mg/kg of C144-LS and 15 mg/kg of C135-LS, intravenously
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
S3 - Open Label
n=8 participants at risk
200 mg of C144-LS and 200 mg of C135-LS or placebo, subcutaneously.
C144-LS and C-135-LS: A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Tenderness
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Injection Site Pain
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
66.7%
2/3 • Number of events 2 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
25.0%
2/8 • Number of events 2 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Peripheral edema
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Endocrine disorders
Increased blood glucose
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Infections and infestations
SARS-CoV-2 Antibody Positive
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
25.0%
2/8 • Number of events 2 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/3 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
0.00%
0/8 • 48 weeks
Definitions are the definitions from clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place