Trial Outcomes & Findings for A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery (NCT NCT04829916)
NCT ID: NCT04829916
Last Updated: 2024-04-23
Results Overview
* number (%) of subjects with at least one AE * number (%) of subjects with at least one SAE * number (%) of subjects with at least one Treatment-Emergent AE (TEAE) * number (%) of subjects with at least one serious TEAE * number (%) of subjects with at least one non-serious TEAE * number (%) of subjects with at least one TEAE of special interest * number (%) of subjects with at least one TEAEs reported as related (possible/probable) to IMP * number (%) of subjects with at least one TEAEs leading to withdrawal of IMP
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Baseline through day 30
Results posted on
2024-04-23
Participant Flow
In this study, 13 subjects were enrolled, ie agreed to participate in the study following completion of the informed consent process. However, 1 subject did not fulfill all eligibility criteria and was not randomization. Hence, 12 subjects started the study, ie were assigned to one of the treatment arms.
Participant milestones
| Measure |
RMC-035
Participants received RMC-035 intravenously
RMC-035: Multiple dosing during 48 hours following cardiac surgery
|
Placebo
Participants received matching placebo solution intravenously
Placebo: Multiple dosing during 48 hours following cardiac surgery
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
4
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
RMC-035
Participants received RMC-035 intravenously
RMC-035: Multiple dosing during 48 hours following cardiac surgery
|
Placebo
Participants received matching placebo solution intravenously
Placebo: Multiple dosing during 48 hours following cardiac surgery
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
Baseline characteristics by cohort
| Measure |
RMC-035
n=8 Participants
Participants received RMC-035 intravenously
RMC-035: Multiple dosing during 48 hours following cardiac surgery
|
Placebo
n=4 Participants
Participants received matching placebo solution intravenously
Placebo: Multiple dosing during 48 hours following cardiac surgery
|
Total
n=12 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
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
74.6 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
70.4 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
73.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Weight
|
89.75 kilogram
STANDARD_DEVIATION 14.84 • n=5 Participants
|
78.75 kilogram
STANDARD_DEVIATION 2.99 • n=7 Participants
|
86.08 kilogram
STANDARD_DEVIATION 13.11 • n=5 Participants
|
|
BMI
|
29.04 kg/m^2
STANDARD_DEVIATION 3.42 • n=5 Participants
|
24.99 kg/m^2
STANDARD_DEVIATION 0.71 • n=7 Participants
|
27.69 kg/m^2
STANDARD_DEVIATION 3.40 • n=5 Participants
|
|
eGFR
|
52.6 mL/min/1.73m^2
STANDARD_DEVIATION 16.5 • n=5 Participants
|
76.0 mL/min/1.73m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
60.4 mL/min/1.73m^2
STANDARD_DEVIATION 17.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through day 30Population: All subject who received any dose of study drug.
* number (%) of subjects with at least one AE * number (%) of subjects with at least one SAE * number (%) of subjects with at least one Treatment-Emergent AE (TEAE) * number (%) of subjects with at least one serious TEAE * number (%) of subjects with at least one non-serious TEAE * number (%) of subjects with at least one TEAE of special interest * number (%) of subjects with at least one TEAEs reported as related (possible/probable) to IMP * number (%) of subjects with at least one TEAEs leading to withdrawal of IMP
Outcome measures
| Measure |
RMC-035
n=8 Participants
Participants received RMC-035 intravenously
RMC-035: Multiple dosing during 48 hours following cardiac surgery
|
Placebo
n=4 Participants
Participants received matching placebo solution intravenously
Placebo: Multiple dosing during 48 hours following cardiac surgery
|
|---|---|---|
|
Frequency of Adverse Events (AEs)
Subject with at least one AE
|
6 Participants
|
1 Participants
|
|
Frequency of Adverse Events (AEs)
Subject with at least one SAE
|
3 Participants
|
1 Participants
|
|
Frequency of Adverse Events (AEs)
Subjects with at least one TEAE
|
5 Participants
|
1 Participants
|
|
Frequency of Adverse Events (AEs)
Subjects with at least one non-serious TEAE
|
5 Participants
|
1 Participants
|
|
Frequency of Adverse Events (AEs)
Subjects with at least one serious TEAE
|
2 Participants
|
1 Participants
|
|
Frequency of Adverse Events (AEs)
Subjects with at least one TEAE of special interest
|
0 Participants
|
0 Participants
|
|
Frequency of Adverse Events (AEs)
Subjects with at least one TEAE reported as related (possible/probable)
|
0 Participants
|
0 Participants
|
|
Frequency of Adverse Events (AEs)
Subjects with at least one TEAE leading to withdrawal of IMP
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 4 days from first dose of IMPPopulation: Number of TEAEs occurring in 5 subjects on RMC-035 (N=8) and the # of TEAEs occurring in 1 subjects on placebo (N=4)
\- Number of TEAEs per category (mild, moderate, severe life-threatening, death)
Outcome measures
| Measure |
RMC-035
n=8 Participants
Participants received RMC-035 intravenously
RMC-035: Multiple dosing during 48 hours following cardiac surgery
|
Placebo
n=4 Participants
Participants received matching placebo solution intravenously
Placebo: Multiple dosing during 48 hours following cardiac surgery
|
|---|---|---|
|
Severity of AEs
Mild
|
3 TEAEs
|
1 TEAEs
|
|
Severity of AEs
Moderate
|
5 TEAEs
|
2 TEAEs
|
|
Severity of AEs
Severe
|
3 TEAEs
|
2 TEAEs
|
|
Severity of AEs
Life-threatening
|
1 TEAEs
|
0 TEAEs
|
|
Severity of AEs
Death
|
1 TEAEs
|
0 TEAEs
|
SECONDARY outcome
Timeframe: Blood samples taken from pre-dose and up to two hours after start of Dose 5Population: All subjects receiving any study drug.
Analysis of RMC-035 concentration in plasma (AUC + t1/2) after fourth infusion.
Outcome measures
| Measure |
RMC-035
n=8 Participants
Participants received RMC-035 intravenously
RMC-035: Multiple dosing during 48 hours following cardiac surgery
|
Placebo
Participants received matching placebo solution intravenously
Placebo: Multiple dosing during 48 hours following cardiac surgery
|
|---|---|---|
|
Maximum Observed Concentration (Cmax)
|
12.3 mikrogram / milliliter
Standard Deviation 4.4
|
—
|
SECONDARY outcome
Timeframe: Blood samples taken from pre-dose and up to two hours after start of Dose 5Population: All subjects receiving RMC-035
Analysis of RMC-035 concentrations in plasma following the fourth infusion.
Outcome measures
| Measure |
RMC-035
n=8 Participants
Participants received RMC-035 intravenously
RMC-035: Multiple dosing during 48 hours following cardiac surgery
|
Placebo
Participants received matching placebo solution intravenously
Placebo: Multiple dosing during 48 hours following cardiac surgery
|
|---|---|---|
|
Area Under the Curve (AUC) 0-24h
|
38.3 hours * microgram / milliliter
Standard Deviation 37.7
|
—
|
SECONDARY outcome
Timeframe: Blood samples taken from pre-dose and up to two hours after start of Dose 5Population: All subjects receiving any RMC-035
Analysis of RMC-035 concentration in plasma following the fourth infusion
Outcome measures
| Measure |
RMC-035
n=8 Participants
Participants received RMC-035 intravenously
RMC-035: Multiple dosing during 48 hours following cardiac surgery
|
Placebo
Participants received matching placebo solution intravenously
Placebo: Multiple dosing during 48 hours following cardiac surgery
|
|---|---|---|
|
Elimination Half-life (T1/2)
|
4.5 hours
Standard Deviation 1.6
|
—
|
Adverse Events
RMC-035
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RMC-035
n=8 participants at risk
Participants received RMC-035 intravenously
RMC-035: Multiple dosing during 48 hours following cardiac surgery
|
Placebo
n=4 participants at risk
Participants received matching placebo solution intravenously
Placebo: Multiple dosing during 48 hours following cardiac surgery
|
|---|---|---|
|
Cardiac disorders
Cardiac tamponade
|
12.5%
1/8 • Full study period, ie baseline through day 30.
|
0.00%
0/4 • Full study period, ie baseline through day 30.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/8 • Full study period, ie baseline through day 30.
|
25.0%
1/4 • Full study period, ie baseline through day 30.
|
|
Gastrointestinal disorders
Large intestine perforation
|
12.5%
1/8 • Full study period, ie baseline through day 30.
|
0.00%
0/4 • Full study period, ie baseline through day 30.
|
|
Infections and infestations
Anaphylactoid reaction
|
12.5%
1/8 • Full study period, ie baseline through day 30.
|
0.00%
0/4 • Full study period, ie baseline through day 30.
|
|
Renal and urinary disorders
Acute kidney injury
|
25.0%
2/8 • Full study period, ie baseline through day 30.
|
0.00%
0/4 • Full study period, ie baseline through day 30.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Full study period, ie baseline through day 30.
|
25.0%
1/4 • Full study period, ie baseline through day 30.
|
Other adverse events
| Measure |
RMC-035
n=8 participants at risk
Participants received RMC-035 intravenously
RMC-035: Multiple dosing during 48 hours following cardiac surgery
|
Placebo
n=4 participants at risk
Participants received matching placebo solution intravenously
Placebo: Multiple dosing during 48 hours following cardiac surgery
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Full study period, ie baseline through day 30.
|
0.00%
0/4 • Full study period, ie baseline through day 30.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/8 • Full study period, ie baseline through day 30.
|
25.0%
1/4 • Full study period, ie baseline through day 30.
|
|
Cardiac disorders
Pericardial effusion
|
12.5%
1/8 • Full study period, ie baseline through day 30.
|
0.00%
0/4 • Full study period, ie baseline through day 30.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
12.5%
1/8 • Full study period, ie baseline through day 30.
|
0.00%
0/4 • Full study period, ie baseline through day 30.
|
|
General disorders
Impaired healing
|
12.5%
1/8 • Full study period, ie baseline through day 30.
|
0.00%
0/4 • Full study period, ie baseline through day 30.
|
|
Infections and infestations
Postoperative wound infection
|
12.5%
1/8 • Full study period, ie baseline through day 30.
|
25.0%
1/4 • Full study period, ie baseline through day 30.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Full study period, ie baseline through day 30.
|
0.00%
0/4 • Full study period, ie baseline through day 30.
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
12.5%
1/8 • Full study period, ie baseline through day 30.
|
0.00%
0/4 • Full study period, ie baseline through day 30.
|
|
Metabolism and nutrition disorders
Respiratory failure
|
0.00%
0/8 • Full study period, ie baseline through day 30.
|
25.0%
1/4 • Full study period, ie baseline through day 30.
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
12.5%
1/8 • Full study period, ie baseline through day 30.
|
0.00%
0/4 • Full study period, ie baseline through day 30.
|
|
Renal and urinary disorders
Acute kidney injury
|
25.0%
2/8 • Full study period, ie baseline through day 30.
|
25.0%
1/4 • Full study period, ie baseline through day 30.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
37.5%
3/8 • Full study period, ie baseline through day 30.
|
0.00%
0/4 • Full study period, ie baseline through day 30.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place