RSV InfectionPhase 1NCT05118386
Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults
A Phase 1 study testing RSM01 in people with RSV Infection, run by Gates Medical Research Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- RSV Infection
- What is being tested?
- RSM01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2021to 7 Dec 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 49 years of age (inclusive), at the time of signing the informed consent.
- Participant is healthy as determined by medical evaluation including medical history, physical examination and laboratory tests.
- Body mass index (BMI) 18 to 29.9 kg/m2 (inclusive)
- Both males and females are eligible to participate. Female participants must not be pregnant, breastfeeding, or attempting to become pregnant for 28 days prior to screening and throughout the duration of the study. Females must be willing to comply with protocol-specified contraception for the duration of their participation in the study and for 90 days following the completion of the study. Male participants with partners of childbearing potential must be willing to comply with protocol specific contraception for the duration of their participation in the study and for 90 days following the completion of the study. Males must also agree to refrain from sperm donation for at least 90 days after they complete the study.
- Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
- Participant agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to relocate from the study area for the duration of the study.
Who cannot join
- Acute illness and/or body temperature ≥37.5°C or ≥99.5°F on Study Day 1. NOTE: This is a temporary exclusion for which the participant may be re-evaluated
- Evidence and/or history of clinically significant medical condition(s) as judged by the investigator, including malignancies, diabetes mellitus, and unstable or uncontrolled hypertension
- History of any autoimmune disease or immune deficiency or other impairment to the immune system, including but not limited to HIV, autoimmune conditions, or immunosuppressive therapy. Note: history of Hashimoto's thyroiditis is not an exclusion criterion
- History of anaphylaxis
- Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol
- Receiving or plans to receive any medications or other therapies that may impact the immune system such as allergy injections, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with major organ toxicity within 90 days prior to Day 1
Show all 23Show fewer
- Received any vaccination (including COVID-19 vaccine) within the 15 days before Day 1 or plans to receive a dose of any vaccine during the 15-day period following Day 1
- Receiving or plans to receive immunosuppressive agents including systemic steroids within 90 days prior to Day 1 (individuals using inhaled or topical corticosteroids, prednisone (or equivalent) dose of ≤ 20 mg/day for ≤ 14 days, and intra-articular corticosteroids are permitted)
- Received or donated blood or blood products within 90 days prior to Day 1 or plans to receive or donate during the study period
- Received or plans to receive antibody or biologic therapy within 180 days prior to Day 1 or any time during the study period, whether licensed or investigational (e.g., immunoglobulin products, monoclonal antibodies, or antibody fragments)
- Participation in an interventional clinical trial and/or receipt of any investigational drug within 30 days or 5 half-lives of the investigational drug before the first day of study drug dosing in this study, whichever is longer.
- Concurrent enrollment in another interventional study
- Previously participated and received study intervention in the current study
- Female participants: positive serum pregnancy test
- Safety laboratory values outside of normal range, for age and sex that are suggestive of a disease state (Grade 1 abnormalities will not lead to exclusion if the investigator considers them not clinically significant.)
- Urinalysis abnormality greater than Grade 1 (with the exception of hematuria in a menstruating female), or urinalysis abnormality judged clinically significant by the investigator
- Clinically significant ECG abnormalities
- Reactive HIV antibody testing
- Current hepatitis B and/or hepatitis C infection
- Positive urine drug screen at screening or Day -1 (with the exception of prescribed drugs)
- History of allergy or hypersensitivity to the study drug, excipients or related substances
- Female participants with any one of the following conditions: currently pregnant or lactating/nursing; has positive serum pregnancy test during the Screening Phase, planning a pregnancy within 1 year after first dose of study drug
- Acting as study personnel or immediate family members (brother, sister, child, parent) or the spouse/partner of study personnel
Trial locations and contacts
1 site in 1 country.
United States1 site
PPD Phase I Clinic - Orlando
Orlando, Florida, 32806-1041
About this study
Official title: A Phase 1 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of RSM01, a Monoclonal Antibody Targeting Respiratory Syncytial Virus, in Healthy Adults
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.
Read the detailed description
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.
- Conditions
- RSV Infection
- Being tested
- RSM01, Placebo
- Keywords
- Monoclonal antibody
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSM01Drug
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
PlaceboOther
Cohort 1: Placebo IV
Cohort 2: Placebo IM
Cohort 3: Placebo IV
Cohort 4: Placebo IV
Cohort 5: Placebo IM
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: RSM01 |
| Placebo | Placebo comparator | Participants received Placebo matched to RSM01. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through Day 7
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
Measured: Up to Day 7
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) and post-Baseline through Day 151
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start16 Nov 2021
- Primary completion23 Aug 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gates Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- PPD Phase I Clinic - Orlando
- Responsible party
- Sponsor
- Investigators
- Gates MRI, Study director, Gates Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118386
- Sponsor's protocol ID
- Gates MRI-RSM01-101
- Status last verified
- Dec 2023
- First submitted
- 6 Oct 2021
- Last updated
- 20 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39696004Bonavia 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.
PubMed 39627701Terstappen 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.
PubMed 39052716
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of RSM01, a Monoclonal Antibody Targeting Respiratory Syncytial Virus, in Healthy Adults
- ClinicalTrials.gov ID
- NCT05118386
- Acronym / sponsor ID
- Gates MRI-RSM01-101
- Conditions
- RSV Infection
- Keywords
- Monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gates Medical Research InstituteUniversity, hospital or other
- Collaborators
- PPD Phase I Clinic - Orlando
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 12 Nov 2021 (actual)
- Results
- Posted 20 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| RSM01 | Experimental | Drug: RSM01Participants 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 | Other: PlaceboParticipants received Placebo matched to RSM01. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participant must be 18 to 49 years of age (inclusive), at the time of signing the informed consent.
- Participant is healthy as determined by medical evaluation including medical history, physical examination and laboratory tests.
- Body mass index (BMI) 18 to 29.9 kg/m2 (inclusive)
- Both males and females are eligible to participate. Female participants must not be pregnant, breastfeeding, or attempting to become pregnant for 28 days prior to screening and throughout the duration of the study. Females must be willing to comply with protocol-specified contraception for the duration of their participation in the study and for 90 days following the completion of the study. Male participants with partners of childbearing potential must be willing to comply with protocol specific contraception for the duration of their participation in the study and for 90 days following the completion of the study. Males must also agree to refrain from sperm donation for at least 90 days after they complete the study.
- Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
Key exclusion criteria (23 listed)
- Acute illness and/or body temperature ≥37.5°C or ≥99.5°F on Study Day 1. NOTE: This is a temporary exclusion for which the participant may be re-evaluated
- Evidence and/or history of clinically significant medical condition(s) as judged by the investigator, including malignancies, diabetes mellitus, and unstable or uncontrolled hypertension
- History of any autoimmune disease or immune deficiency or other impairment to the immune system, including but not limited to HIV, autoimmune conditions, or immunosuppressive therapy. Note: history of Hashimoto's thyroiditis is not an exclusion criterion
- History of anaphylaxis
- Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSM01Cohort 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 | Drug | RSM01 |
| PlaceboCohort 1: Placebo IV Cohort 2: Placebo IM Cohort 3: Placebo IV Cohort 4: Placebo IV Cohort 5: Placebo IM | Other | Placebo |
Primary outcome
Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151
Time frame: Day 1 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.
Number of Participants With Serious Adverse Events (SAEs) and AE of Special Interest (AESIs) Through Day 151
Time frame: Day 1 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.
Number of Participants With Solicited Systemic AEs for 7 Days After Dose Administration
Time frame: Through Day 7
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.
Number of Participants With Solicited Local AEs for Injection Site Reactions for 7 Days After Intramuscular Dose Administration
Time frame: Up to Day 7
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
16 secondary outcomes
Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151
Time frame: Through Day 151
Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151
Time frame: Through Day 151
Area Under the Capillary Blood-concentration Time Curve From Zero to Infinity (AUC 0-infinity) After Administration of RSM01
Time frame: Day 151
Day 91 Capillary Blood-concentration (CD91) After Administration of RSM01
Time frame: Day 91
Day 91 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D91) After Administration of RSM01
Time frame: Day 91
Day 151 Capillary Blood-concentration (CD151) After Administration of RSM01
Time frame: Day 151
Day 151 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D151) After Administration of RSM01
Time frame: Day 151
Maximum Capillary Blood Concentration (Cmax) After Administration of RSM01
Time frame: Day 151
Minimum Capillary Blood Concentration (Cmin) After Administration of RSM01
Time frame: Day 151
Time to Maximum Capillary Blood-concentration (Tmax) After Administration of RSM01
Time frame: Day 151
Apparent Terminal Half-Life After Administration of RSM01
Time frame: Day 151
Total Body Clearance (CL) After Intravenous Dose Administration of RSM01
Time frame: Day 151
Apparent Total Body Clearance (CL) After Intramuscular Dose Administration of RSM01
Time frame: Day 151
Volume of Distribution (Vz) After Intravenous Dose Administration of RSM01
Time frame: Day 151
Apparent Volume of Distribution (Vz) After Intramuscular Dose Administration of RSM01
Time frame: Day 151
Number of Participants With Positive Anti-drug Antibodies (ADAs) at Baseline and Post-Baseline Through Day 151 Following RSM01 Administration
Time frame: Baseline (Day 1) and post-Baseline through Day 151
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39696004White 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.
- Derived from this study: PubMed 39627701Bonavia 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.
- Derived from this study: PubMed 39052716Terstappen 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.
- Individual participant dataSharing planned: Yes. 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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Respiratory Syncytial Virus (RSV), Infectious Disease
Not yet recruitingPhase 3
A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection
RecruitingObservational study
Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)
COVID-19, SARS-CoV-2 Infection, RSV
RecruitingPhase 2/3
A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
RSV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gates MRI study director
Gates Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RSM01 in people with RSV Infection, run by Gates Medical Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Unsolicited Treatment Emergent Adverse Events (TEAEs) Through Day 151 (time frame: Day 1 through Day 151). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118386, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.