Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults

NCT05118386 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: Gates MRI-RSM01-101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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 of RSM01 to healthy adults.

Conditions

RSV Infection

Keywords

Monoclonal antibody

Outcome Measures

Primary Outcomes (4)

• 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

  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

Secondary Outcomes (16)

• Number of Participants With Clinically Significant Hematology Assessments of Grade 1 and Above Through Day 151

  Through Day 151

• Number of Participants With Clinically Significant Clinical Chemistry Assessments of Grade 1 and Above Through Day 151

  Through Day 151

• Area Under the Capillary Blood-concentration Time Curve From Zero to Infinity (AUC 0-infinity) After Administration of RSM01

  Day 151

• Day 91 Capillary Blood-concentration (CD91) After Administration of RSM01

  Day 91

• Day 91 Area Under the Capillary Blood-concentration Time Curve (AUC 0-D91) After Administration of RSM01

  Day 91

Study Arms (2)

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.

Drug: RSM01

Placebo

PLACEBO COMPARATOR

Participants received Placebo matched to RSM01.

Other: Placebo

Interventions

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

RSM01

Placebo OTHER

Cohort 1: Placebo IV Cohort 2: Placebo IM Cohort 3: Placebo IV Cohort 4: Placebo IV Cohort 5: Placebo IM

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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
• 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
• 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

Sponsors & Collaborators

• Gates Medical Research Institute: lead
• PPD Phase I Clinic - Orlando: collaborator

Study Sites (1)

PPD Phase I Clinic - Orlando

Orlando, Florida, 32806-1041, United States

Location

Related Publications (3)

• 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.

  PMID: 39696004 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.

  PMID: 39627701 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.

  PMID: 39052716 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Study Director
• Organization: Gates Medical Research Institute

clinical.trials@gatesmri.org

+1 857 702 2108

Study Officials

• Gates MRI

  Gates Medical Research Institute

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and all study personnel were blinded to the randomization. Authorized study site personnel would administer doses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 12, 2021
• Study Start: November 16, 2021
• Primary Completion: August 23, 2022
• Study Completion: December 7, 2022
• Last Updated: May 20, 2024
• Results First Posted: May 20, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)