Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults (NCT NCT05118386)
NCT ID: NCT05118386
Last Updated: 2024-05-20
Results Overview
A TEAE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A memory aid was utilized by participants to collect unsolicited TEAEs beginning at discharge from the clinic, through Day 151. Participants were instructed to record unsolicited TEAEs whenever they occurred, recording such TEAEs on the memory aid. The memory aids were collected and reviewed by site staff at each subsequent visit through the end of the study. Number of participants with unsolicited TEAEs through Day 151 has been presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Day 1 through Day 151
Results posted on
2024-05-20
Participant Flow
The study was conducted in United States
The study was conducted in 2 parts: Dose Escalation Phase followed by an Expansion Phase. Participants were randomized 6:1 to RSM01 or Placebo in each dose cohort. Results are presented by intervention.
Participant milestones
| Measure |
RSM01 300 Milligrams (mg) Intravenous (IV)
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg Intramuscular (IM)
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Dose Escalation Phase (Day 1 to Day 151)
STARTED
|
6
|
6
|
6
|
6
|
0
|
4
|
|
Dose Escalation Phase (Day 1 to Day 151)
COMPLETED
|
6
|
6
|
6
|
4
|
0
|
4
|
|
Dose Escalation Phase (Day 1 to Day 151)
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Dose Expansion Phase (Day 1 to Day 151)
STARTED
|
0
|
0
|
0
|
0
|
24
|
4
|
|
Dose Expansion Phase (Day 1 to Day 151)
COMPLETED
|
0
|
0
|
0
|
0
|
23
|
4
|
|
Dose Expansion Phase (Day 1 to Day 151)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
RSM01 300 Milligrams (mg) Intravenous (IV)
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg Intramuscular (IM)
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Dose Escalation Phase (Day 1 to Day 151)
Lost to Follow-up
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Dose Expansion Phase (Day 1 to Day 151)
Unspecified Reason Not Completed
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults
Baseline characteristics by cohort
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=6 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=24 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
n=8 Participants
Participants randomized to Placebo within the dose cohorts are pooled.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.2 Years
STANDARD_DEVIATION 4.26 • n=5 Participants
|
30.7 Years
STANDARD_DEVIATION 9.40 • n=7 Participants
|
31.5 Years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
27.5 Years
STANDARD_DEVIATION 9.54 • n=4 Participants
|
34.1 Years
STANDARD_DEVIATION 8.69 • n=21 Participants
|
30.9 Years
STANDARD_DEVIATION 5.33 • n=10 Participants
|
31.6 Years
STANDARD_DEVIATION 8.13 • n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
27 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
37 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 151Population: Safety Population
A TEAE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A memory aid was utilized by participants to collect unsolicited TEAEs beginning at discharge from the clinic, through Day 151. Participants were instructed to record unsolicited TEAEs whenever they occurred, recording such TEAEs on the memory aid. The memory aids were collected and reviewed by site staff at each subsequent visit through the end of the study. Number of participants with unsolicited TEAEs through Day 151 has been presented.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=6 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=24 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
n=8 Participants
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 151Population: Safety Population
An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. AESIs were defined as events of potential immunologic etiology, including immune-related AEs (irAEs). Number of participants with SAEs and AESIs through Day 151 has been presented.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=6 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=24 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
n=8 Participants
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151
AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through Day 7Population: Safety Population
Solicited systemic AEs were defined events that participants were specifically asked about and which were noted by participants in the diary card. Systemic solicited AEs included fever, headache, tiredness, joint pain, muscle pain, nausea, vomiting and diarrhea. Number of participants with solicited systemic AEs for 7 days after dose administration has been presented.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=6 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=24 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
n=8 Participants
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration
Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration
Tiredness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration
Joint pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration
Muscle pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration
Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration
Vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration
Diarrhea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration
Headache
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7Population: Safety Population. Data has been presented only for participants who received RSM01 and placebo intramuscularly.
Solicited local AEs were defined events that participants were specifically asked about and which were noted by participants in the diary card. Solicited local AEs for injection site reactions included AEs include pain, redness and swelling. Number of participants with solicited local AEs for injection site reactions for 7 days after intramuscular dose administration has been presented
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=24 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=5 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration
Pain
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration
Redness
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration
Swelling
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through Day 151Population: Safety Population. Only those participants with data available at specified time points has been presented.
Blood samples were collected for the assessment of hemoglobin, platelets, leukocytes, neutrophils and lymphocytes. Laboratory grades were evaluated using the Food and Drug administration (FDA) Toxicity Grading Scale with grading as: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening or disabling. Number of participants with clinically significant hematology assessments of Grade 1 and above has been presented.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=4 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=23 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
n=8 Participants
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Hemoglobin: Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Hemoglobin: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Hemoglobin: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Hemoglobin: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Platelets: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Platelets: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Leukocytes: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Leukocytes: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Neutrophils: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Platelets: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Leukocytes: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Leukocytes: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Neutrophils: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Neutrophils: Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Neutrophils: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Lymphocytes: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Lymphocytes: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Lymphocytes: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Lymphocytes: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Platelets: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through Day 151Population: Safety Population. Only those participants with data available at specified time points has been presented.
Blood samples were collected for the assessment of Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Gamma Glutamyl Transferase, Creatinine, Urea nitrogen, Glucose, Albumin, Sodium and Potassium. Laboratory grades were evaluated using the FDA Toxicity Grading Scale with grading as: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening or disabling. Number of participants with clinically significant clinical chemistry assessments of Grade 1 and above has been presented.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=4 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=23 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
n=8 Participants
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Alanine Aminotransferase: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Creatinine: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Glucose: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Glucose: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Glucose: Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Glucose: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Alanine Aminotransferase: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Alanine Aminotransferase: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Alanine Aminotransferase: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Aspartate Aminotransferase: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Aspartate Aminotransferase: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Aspartate Aminotransferase: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Aspartate Aminotransferase: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Alkaline Phosphatase: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Alkaline Phosphatase: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Alkaline Phosphatase: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Alkaline Phosphatase: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Bilirubin: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Bilirubin: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Bilirubin: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Bilirubin: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Gamma Glutamyl Transferase: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Gamma Glutamyl Transferase: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Gamma Glutamyl Transferase: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Gamma Glutamyl Transferase: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Creatinine: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Creatinine: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Creatinine: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Urea nitrogen: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Urea nitrogen: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Urea nitrogen: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Urea nitrogen: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Albumin: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Albumin: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Albumin: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Albumin: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Sodium: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Sodium: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Sodium: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Sodium: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Potassium: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Potassium: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Potassium: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Potassium: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 151Population: Pharmacokinetic (PK) population: included all participants who received the study intervention. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. AUC(0-infinity) in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics.
Outcome measures
| Measure |
RSM01 300 mg IV
n=1 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=2 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=2 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=1 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=1 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Area Under the Capillary Blood-concentration Time Curve From Zero to Infinity (AUC 0-infinity) After Administration of RSM01
|
25700000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Not applicable (NA) indicates geometric coefficient of variation could not be calculated as a single participant was analyzed.
|
25300000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 23.6
|
239000000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 26.4
|
1010000000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Not applicable (NA) indicates geometric coefficient of variation could not be calculated as a single participant was analyzed.
|
106000000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
Not applicable (NA) indicates geometric coefficient of variation could not be calculated as a single participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: Day 91Population: PK population.
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=6 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=24 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Day 91 Capillary Blood-concentration (CD91) After Administration of RSM01
|
14500 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 83.5
|
8020 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 209.6
|
63400 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 38.8
|
196000 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 25.9
|
27600 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 76.7
|
—
|
SECONDARY outcome
Timeframe: Day 91Population: PK population.
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=6 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=24 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Day 91 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D91) After Administration of RSM01
|
50900000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 42.0
|
40600000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 44.3
|
207000000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 22.8
|
549000000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 17.3
|
85400000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 39.3
|
—
|
SECONDARY outcome
Timeframe: Day 151Population: PK population. Only those participants with data available at the specified data points were analyzed
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=6 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=23 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Day 151 Capillary Blood-concentration (CD151) After Administration of RSM01
|
13500 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 13.4
|
12100 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 8.2
|
36800 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 58.8
|
105000 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 32.7
|
17900 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 76.8
|
—
|
SECONDARY outcome
Timeframe: Day 151Population: PK population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=5 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=4 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=23 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Day 151 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D151) After Administration of RSM01
|
68700000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 53.8
|
48400000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 69.3
|
278000000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 27.5
|
813000000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 22.9
|
114000000 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 48.3
|
—
|
SECONDARY outcome
Timeframe: Day 151Population: PK population.
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=6 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=24 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Maximum Capillary Blood Concentration (Cmax) After Administration of RSM01
|
62200 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20.3
|
31500 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 17.6
|
264000 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 18.2
|
652000 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 13.8
|
56400 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 23.9
|
—
|
SECONDARY outcome
Timeframe: Day 151Population: PK population.
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=6 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=24 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Minimum Capillary Blood Concentration (Cmin) After Administration of RSM01
|
13500 Nanograms per milliliter (Ng/mL)
Geometric Coefficient of Variation 13.4
|
3670 Nanograms per milliliter (Ng/mL)
Geometric Coefficient of Variation 68.9
|
36100 Nanograms per milliliter (Ng/mL)
Geometric Coefficient of Variation 56.7
|
127000 Nanograms per milliliter (Ng/mL)
Geometric Coefficient of Variation 38.7
|
18700 Nanograms per milliliter (Ng/mL)
Geometric Coefficient of Variation 78.5
|
—
|
SECONDARY outcome
Timeframe: Day 151Population: PK population.
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=6 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=24 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Time to Maximum Capillary Blood-concentration (Tmax) After Administration of RSM01
|
1.300 Hours
Interval 1.25 to 9.28
|
140.458 Hours
Interval 121.35 to 168.88
|
1.808 Hours
Interval 1.75 to 1.97
|
2.208 Hours
Interval 2.18 to 10.17
|
193.508 Hours
Interval 165.77 to 695.38
|
—
|
SECONDARY outcome
Timeframe: Day 151Population: PK population. Only those participants with data available at the specified data points were analyzed
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. Apparent terminal half-life in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics.
Outcome measures
| Measure |
RSM01 300 mg IV
n=1 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=2 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=2 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=1 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=1 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Half-Life After Administration of RSM01
|
653 Hours
Interval 653.0 to 653.0
|
439 Hours
Interval 438.0 to 440.0
|
1310 Hours
Interval 1220.0 to 1400.0
|
1060 Hours
Interval 1060.0 to 1060.0
|
1480 Hours
Interval 1480.0 to 1480.0
|
—
|
SECONDARY outcome
Timeframe: Day 151Population: PK population. Only those participants with data available at the specified data points were analyzed. Data has been presented only for participants who received RSM01 intravenously
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. CL post intravenous administration in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics.
Outcome measures
| Measure |
RSM01 300 mg IV
n=1 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=2 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=1 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Total Body Clearance (CL) After Intravenous Dose Administration of RSM01
|
11.7 Milliliter per hour (mL/h)
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
4.25 Milliliter per hour (mL/h)
Standard Deviation 1.09
|
2.98 Milliliter per hour (mL/h)
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 151Population: PK population. Only those participants with data available at the specified data points were analyzed. Data has been presented only for participants who received RSM01 intramuscularly.
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. Total body CL post intramuscular administration in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics.
Outcome measures
| Measure |
RSM01 300 mg IV
n=2 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=1 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance (CL) After Intramuscular Dose Administration of RSM01
|
12.0 Milliliter per hour (mL/h)
Standard Deviation 2.77
|
5.68 Milliliter per hour (mL/h)
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 151Population: PK population. Only those participants with data available at the specified data points were analyzed. Data has been presented only for participants who received RSM01 intravenously
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. Vz post intravenous administration in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics.
Outcome measures
| Measure |
RSM01 300 mg IV
n=1 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=2 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=1 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Volume of Distribution (Vz) After Intravenous Dose Administration of RSM01
|
11000 Milliliter (mL)
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
7920 Milliliter (mL)
Standard Deviation 1310
|
4550 Milliliter (mL)
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 151Population: PK population. Only those participants with data available at the specified data points were analyzed. Data has been presented only for participants who received RSM01 intramuscularly.
Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. Vz post intramuscular administration in participants with AUC extrapolation exceeding 20% was deemed unreliable in the terminal phase and thus omitted from the summary statistics.
Outcome measures
| Measure |
RSM01 300 mg IV
n=2 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=1 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz) After Intramuscular Dose Administration of RSM01
|
7610 Milliliter (mL)
Standard Deviation 1740
|
12200 Milliliter (mL)
Standard Deviation NA
NA indicates standard deviation could not be calculated as a single participant was analyzed
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and post-Baseline through Day 151Population: Immunogenicity Population: all participants who received the study intervention and have at least one valid ADA result
Whole blood samples in serum separator tubes and volumetric absorptive microsampling (VAMS) samples were collected for detection of ADAs against RSM01 in serum and capillary blood, respectively. The detection of ADA to RSM01 was performed using a validated immunoassay method with tiered testing of screening, confirmatory, and titration. Number of participants with positive ADAs at Baseline and post-Baseline through Day 151 following RSM01 administration has been presented.
Outcome measures
| Measure |
RSM01 300 mg IV
n=6 Participants
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 Participants
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 Participants
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=6 Participants
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=24 Participants
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
n=8 Participants
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration
Baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration
Post-Baseline Through Day 151
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
RSM01 300 mg IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
RSM01 300 mg IM
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
RSM01 1000 mg IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
RSM01 3000 mg IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
RSM01 600 mg IM
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
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 |
RSM01 300 mg IV
n=6 participants at risk
Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV
|
RSM01 300 mg IM
n=6 participants at risk
Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM
|
RSM01 1000 mg IV
n=6 participants at risk
Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV
|
RSM01 3000 mg IV
n=6 participants at risk
Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV
|
RSM01 600 mg IM
n=24 participants at risk
Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM
|
Placebo
n=8 participants at risk
Participants randomized to Placebo within the dose cohorts are pooled.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
16.7%
1/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
4.2%
1/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Infections and infestations
Bartholinitis
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
4.2%
1/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
16.7%
1/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
12.5%
1/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
33.3%
2/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
12.5%
1/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
4.2%
1/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
12.5%
1/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
33.3%
2/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
General disorders
Infusion site pain
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
16.7%
1/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
16.7%
1/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
16.7%
1/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
12.5%
1/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
16.7%
1/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Investigations
Blood pressure increased
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
16.7%
1/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
16.7%
1/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
16.7%
1/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/6 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
4.2%
1/24 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
0.00%
0/8 • Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER