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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2022-12-07

Brief Summary

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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.

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Detailed Description

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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

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RSV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Participants and all study personnel were blinded to the randomization. Authorized study site personnel would administer doses.

Study Groups

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RSM01

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.

Group Type EXPERIMENTAL

RSM01

Intervention Type 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

Placebo

Participants received Placebo matched to RSM01.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Cohort 1: Placebo IV

Cohort 2: Placebo IM

Cohort 3: Placebo IV

Cohort 4: Placebo IV

Cohort 5: Placebo IM

Interventions

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RSM01

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

Intervention Type DRUG

Placebo

Cohort 1: Placebo IV

Cohort 2: Placebo IM

Cohort 3: Placebo IV

Cohort 4: Placebo IV

Cohort 5: Placebo IM

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Participant must be 18 to 49 years of age (inclusive), at the time of signing the informed consent.
2. Participant is healthy as determined by medical evaluation including medical history, physical examination and laboratory tests.
3. Body mass index (BMI) 18 to 29.9 kg/m2 (inclusive)
4. 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.
5. 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
6. 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.

Exclusion Criteria

1. 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
2. Evidence and/or history of clinically significant medical condition(s) as judged by the investigator, including malignancies, diabetes mellitus, and unstable or uncontrolled hypertension
3. 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
4. History of anaphylaxis
5. 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
6. 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
7. 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
8. 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)
9. Received or donated blood or blood products within 90 days prior to Day 1 or plans to receive or donate during the study period
10. 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)
11. 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.
12. Concurrent enrollment in another interventional study
13. Previously participated and received study intervention in the current study
14. Female participants: positive serum pregnancy test
15. 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.)
16. Urinalysis abnormality greater than Grade 1 (with the exception of hematuria in a menstruating female), or urinalysis abnormality judged clinically significant by the investigator
17. Clinically significant ECG abnormalities
18. Reactive HIV antibody testing
19. Current hepatitis B and/or hepatitis C infection
20. Positive urine drug screen at screening or Day -1 (with the exception of prescribed drugs)
21. History of allergy or hypersensitivity to the study drug, excipients or related substances
22. 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
23. Acting as study personnel or immediate family members (brother, sister, child, parent) or the spouse/partner of study personnel

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes