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| Name | Class |
|---|---|
| PPD Phase I Clinic - Orlando | OTHER |
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Gates MRI-RSM01-101 was a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and tolerability, pharmacokinetics, occurrence of Anti-drug antibody (ADA), and assessment of neutralizing antibody against RSV after administration of single intravenous or intramuscular doses of RSM01 to healthy adults.
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) among infants and young children, resulting in annual epidemics worldwide.
RSM01, a monoclonal antibody targeting RSV, may potentially provide an effective method to protect infants from RSV disease based on its potency and an extended half-life that is expected to support once-per-RSV-season administration.
This study was a first-in-human evaluation of RSM01 in healthy male and female adults with the goal of characterizing the safety and tolerability of a range of single doses of RSM01 to enable determination of appropriate dose(s) to be administered to infants in a future study. Enrollment was planned at a single study center in the United States. 56 participants were enrolled; 48 participants received RSM01 and 8 participants received Placebo. Participants were followed for approximately 5 months (151 days) after dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSM01 | Experimental | Participants were randomized to receive different dose levels of RSM01. Participants were randomized in a ratio of 6:1 where for every 6 participants received active drug (RSM01), 1 participant received Placebo. |
|
| Placebo | Placebo Comparator | Participants received Placebo matched to RSM01. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSM01 | Drug | Cohort 1: RSM01 300 mg IV Cohort 2: RSM01 300 mg IM Cohort 3: RSM01 1000 mg IV Cohort 4: RSM01 3000 mg IV Cohort 5: RSM01 600 mg IM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151 | 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. | Day 1 through Day 151 |
| Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | 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. | Day 1 through Day 151 |
| Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | 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. | Through Day 7 |
| Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gates MRI | Gates Medical Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase I Clinic - Orlando | Orlando | Florida | 32806-1041 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39696004 | Derived | White JT, Terstappen J, Levi M, Radivojevic A, Noble R, Anderson AB, Wise-Blackman G, Dunne MW. Replacing serum with dried blood microsampling for pharmacokinetics, viral neutralisation and immunogenicity bioanalysis supporting future paediatric development of RSM01, a candidate respiratory syncytial virus neutralising monoclonal antibody. BMC Infect Dis. 2024 Dec 18;24(1):1403. doi: 10.1186/s12879-024-10196-4. | |
| 39627701 |
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Anonymized or deidentified, as appropriate, participant level data may be shared with external researchers in accordance with the trial participants' written and executed informed consent document and any local or applicable regulations on data sharing. Qualified researchers may submit a request for anonymized or de-identified participant level data along with a research proposal to Gates MRI for review. A data sharing agreement must be in place before any clinical trial data are shared. There are additional circumstances that may prevent the sharing of data with external researchers, including but not limited to contractual obligations to existing partners and any restrictions imposed by regulatory bodies.
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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.
The study was conducted in United States
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| ID | Title | Description |
|---|---|---|
| FG000 | RSM01 300 Milligrams (mg) Intravenous (IV) | Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV |
| FG001 | RSM01 300 mg Intramuscular (IM) | Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM |
| FG002 | RSM01 1000 mg IV | Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV |
| FG003 | RSM01 3000 mg IV | Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV |
| FG004 | RSM01 600 mg IM | Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM |
| FG005 | Placebo | Participants randomized to Placebo within the dose cohorts are pooled. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose Escalation Phase (Day 1 to Day 151) |
|
| ||||||||||||||||||
| Dose Expansion Phase (Day 1 to Day 151) |
|
Safety Population: included all participants who received the study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | RSM01 300 mg IV | Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV |
| BG001 | RSM01 300 mg IM | Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151 | 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. | Safety Population | Posted | Count of Participants | Participants | Day 1 through Day 151 |
|
Day 1 through Day 151
Safety population defined as all participants who received the study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RSM01 300 mg IV | Within the RSM01 300 mg IV dose cohort, participants were randomized to receive RSM01 300 mg IV |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Gates Medical Research Institute | +1 857 702 2108 | clinical.trials@gatesmri.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2022 | Sep 25, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 7, 2022 | Sep 25, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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Randomized, double-blind, placebo-controlled study of RSM01. The study was conducted in 2 parts: A Dose Escalation Phase (28 participants) with 4 dosing cohorts, followed by an Expansion Phase (28 participants) with a single cohort.
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Participants and all study personnel were blinded to the randomization. Authorized study site personnel would administer doses.
| Placebo | Other | Cohort 1: Placebo IV Cohort 2: Placebo IM Cohort 3: Placebo IV Cohort 4: Placebo IV Cohort 5: Placebo IM |
|
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
| Up to Day 7 |
| Through Day 151 |
| Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | 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. | Through Day 151 |
| Area Under the Capillary Blood-concentration Time Curve From Zero to Infinity (AUC 0-infinity) After Administration of RSM01 | 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. | Day 151 |
| Day 91 Capillary Blood-concentration (CD91) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | Day 91 |
| Day 91 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D91) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | Day 91 |
| Day 151 Capillary Blood-concentration (CD151) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | Day 151 |
| Day 151 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D151) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | Day 151 |
| Maximum Capillary Blood Concentration (Cmax) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | Day 151 |
| Minimum Capillary Blood Concentration (Cmin) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | Day 151 |
| Time to Maximum Capillary Blood-concentration (Tmax) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | Day 151 |
| Apparent Terminal Half-Life After Administration of RSM01 | 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. | Day 151 |
| Total Body Clearance (CL) After Intravenous Dose Administration of RSM01 | 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. | Day 151 |
| Apparent Total Body Clearance (CL) After Intramuscular Dose Administration of RSM01 | 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. | Day 151 |
| Volume of Distribution (Vz) After Intravenous Dose Administration of RSM01 | 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. | Day 151 |
| Apparent Volume of Distribution (Vz) After Intramuscular Dose Administration of RSM01 | 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. | Day 151 |
| Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | 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. | Baseline (Day 1) and post-Baseline through Day 151 |
| Derived |
| Bonavia A, Levi M, Rouha H, Badarau A, Terstappen J, Watson S, Anderson AB, White JT, Ananworanich J, Taylor D, Radivojevic A, Shaffer M, Stamm LM, Dunne MW. RSM01, a novel respiratory syncytial virus monoclonal antibody: preclinical characterization and results of a first-in-human, randomised clinical trial. BMC Infect Dis. 2024 Dec 3;24(1):1378. doi: 10.1186/s12879-024-10120-w. |
| 39052716 | Derived | Terstappen J, Delemarre EM, Versnel A, White JT, Derrien-Colemyn A, Ruckwardt TJ, Bont LJ, Mazur NI. RSV Neutralizing Antibodies in Dried Blood. J Infect Dis. 2024 Jul 25;230(1):e93-e101. doi: 10.1093/infdis/jiad543. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | RSM01 1000 mg IV | Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV |
| BG003 | RSM01 3000 mg IV | Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV |
| BG004 | RSM01 600 mg IM | Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM |
| BG005 | Placebo | Participants randomized to Placebo within the dose cohorts are pooled. |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | RSM01 300 mg IM | Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM |
| OG002 | RSM01 1000 mg IV | Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV |
| OG003 | RSM01 3000 mg IV | Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV |
| OG004 | RSM01 600 mg IM | Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM |
| OG005 | Placebo | Participants randomized to Placebo within the dose cohorts are pooled. |
|
|
| Primary | Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151 | 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. | Safety Population | Posted | Count of Participants | Participants | Day 1 through Day 151 |
|
|
|
| Primary | Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration | 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. | Safety Population | Posted | Count of Participants | Participants | Through Day 7 |
|
|
|
| Primary | Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration | 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 | Safety Population. Data has been presented only for participants who received RSM01 and placebo intramuscularly. | Posted | Count of Participants | Participants | Up to Day 7 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151 | 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. | Safety Population. Only those participants with data available at specified time points has been presented. | Posted | Count of Participants | Participants | Through Day 151 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151 | 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. | Safety Population. Only those participants with data available at specified time points has been presented. | Posted | Count of Participants | Participants | Through Day 151 |
|
|
|
| Secondary | Area Under the Capillary Blood-concentration Time Curve From Zero to Infinity (AUC 0-infinity) After Administration of RSM01 | 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. | Pharmacokinetic (PK) population: included all participants who received the study intervention. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter (h*ng/mL) | Day 151 |
|
|
|
| Secondary | Day 91 Capillary Blood-concentration (CD91) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | Day 91 |
|
|
|
| Secondary | Day 91 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D91) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter (h*ng/mL) | Day 91 |
|
|
|
| Secondary | Day 151 Capillary Blood-concentration (CD151) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | PK population. Only those participants with data available at the specified data points were analyzed | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | Day 151 |
|
|
|
| Secondary | Day 151 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D151) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | PK population. Only those participants with data available at the specified data points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanograms per milliliter (h*ng/mL) | Day 151 |
|
|
|
| Secondary | Maximum Capillary Blood Concentration (Cmax) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | Day 151 |
|
|
|
| Secondary | Minimum Capillary Blood Concentration (Cmin) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (Ng/mL) | Day 151 |
|
|
|
| Secondary | Time to Maximum Capillary Blood-concentration (Tmax) After Administration of RSM01 | Blood samples were collected at indicated time points for PK analysis of RSM01. PK parameters were analyzed using standard non-compartmental analysis. | PK population. | Posted | Median | Full Range | Hours | Day 151 |
|
|
|
| Secondary | Apparent Terminal Half-Life After Administration of RSM01 | 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. | PK population. Only those participants with data available at the specified data points were analyzed | Posted | Median | Full Range | Hours | Day 151 |
|
|
|
| Secondary | Total Body Clearance (CL) After Intravenous Dose Administration of RSM01 | 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. | 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 | Posted | Mean | Standard Deviation | Milliliter per hour (mL/h) | Day 151 |
|
|
|
| Secondary | Apparent Total Body Clearance (CL) After Intramuscular Dose Administration of RSM01 | 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. | 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. | Posted | Mean | Standard Deviation | Milliliter per hour (mL/h) | Day 151 |
|
|
|
| Secondary | Volume of Distribution (Vz) After Intravenous Dose Administration of RSM01 | 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. | 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 | Posted | Median | Standard Deviation | Milliliter (mL) | Day 151 |
|
|
|
| Secondary | Apparent Volume of Distribution (Vz) After Intramuscular Dose Administration of RSM01 | 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. | 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. | Posted | Median | Standard Deviation | Milliliter (mL) | Day 151 |
|
|
|
| Secondary | Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration | 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. | Immunogenicity Population: all participants who received the study intervention and have at least one valid ADA result | Posted | Count of Participants | Participants | Baseline (Day 1) and post-Baseline through Day 151 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | RSM01 300 mg IM | Within the RSM01 300 mg IM dose cohort, participants were randomized to receive RSM01 300 mg IM | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | RSM01 1000 mg IV | Within the RSM01 1000 mg IV dose cohort, participants were randomized to receive RSM01 1000 mg IV | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | RSM01 3000 mg IV | Within the RSM01 3000 mg IV dose cohort, participants were randomized to receive RSM01 3000 mg IV | 0 | 6 | 0 | 6 | 3 | 6 |
| EG004 | RSM01 600 mg IM | Within the RSM01 600 mg IM dose cohort, participants were randomized to receive RSM01 600 mg IM | 0 | 24 | 0 | 24 | 3 | 24 |
| EG005 | Placebo | Participants randomized to Placebo within the dose cohorts are pooled. | 0 | 8 | 0 | 8 | 2 | 8 |
| Bartholinitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
Not provided
| D014777 | Virus Diseases |
| D007239 | Infections |
| AESI |
|
| Headache |
|
| Tiredness |
|
| Joint pain |
|
| Muscle pain |
|
| Nausea |
|
| Vomiting |
|
| Diarrhea |
|
| Title | Measurements |
|---|---|
|
| Swelling |
|
| Hemoglobin: Grade 2 |
|
| Hemoglobin: Grade 3 |
|
| Hemoglobin: Grade 4 |
|
| Platelets: Grade 1 |
|
| Platelets: Grade 2 |
|
| Platelets: Grade 3 |
|
| Platelets: Grade 4 |
|
| Leukocytes: Grade 1 |
|
| Leukocytes: Grade 2 |
|
| Leukocytes: Grade 3 |
|
| Leukocytes: Grade 4 |
|
| Neutrophils: Grade 1 |
|
| Neutrophils: Grade 2 |
|
| Neutrophils: Grade 3 |
|
| Neutrophils: Grade 4 |
|
| Lymphocytes: Grade 1 |
|
| Lymphocytes: Grade 2 |
|
| Lymphocytes: Grade 3 |
|
| Lymphocytes: Grade 4 |
|
| Alanine Aminotransferase: Grade 2 |
|
| Alanine Aminotransferase: Grade 3 |
|
| Alanine Aminotransferase: Grade 4 |
|
| Aspartate Aminotransferase: Grade 1 |
|
| Aspartate Aminotransferase: Grade 2 |
|
| Aspartate Aminotransferase: Grade 3 |
|
| Aspartate Aminotransferase: Grade 4 |
|
| Alkaline Phosphatase: Grade 1 |
|
| Alkaline Phosphatase: Grade 2 |
|
| Alkaline Phosphatase: Grade 3 |
|
| Alkaline Phosphatase: Grade 4 |
|
| Bilirubin: Grade 1 |
|
| Bilirubin: Grade 2 |
|
| Bilirubin: Grade 3 |
|
| Bilirubin: Grade 4 |
|
| Gamma Glutamyl Transferase: Grade 1 |
|
| Gamma Glutamyl Transferase: Grade 2 |
|
| Gamma Glutamyl Transferase: Grade 3 |
|
| Gamma Glutamyl Transferase: Grade 4 |
|
| Creatinine: Grade 1 |
|
| Creatinine: Grade 2 |
|
| Creatinine: Grade 3 |
|
| Creatinine: Grade 4 |
|
| Urea nitrogen: Grade 1 |
|
| Urea nitrogen: Grade 2 |
|
| Urea nitrogen: Grade 3 |
|
| Urea nitrogen: Grade 4 |
|
| Glucose: Grade 1 |
|
| Glucose: Grade 2 |
|
| Glucose: Grade 3 |
|
| Glucose: Grade 4 |
|
| Albumin: Grade 1 |
|
| Albumin: Grade 2 |
|
| Albumin: Grade 3 |
|
| Albumin: Grade 4 |
|
| Sodium: Grade 1 |
|
| Sodium: Grade 2 |
|
| Sodium: Grade 3 |
|
| Sodium: Grade 4 |
|
| Potassium: Grade 1 |
|
| Potassium: Grade 2 |
|
| Potassium: Grade 3 |
|
| Potassium: Grade 4 |
|
| Post-Baseline Through Day 151 |
|