Mode
Text Size
Log in / Sign up
Phase 2 Completed N=80 Randomized Triple-blind Prevention

Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005)

Respiratory Syncytial Viruses
Source: ClinicalTrials.gov NCT04086472 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Area Under the Viral Load-time Curve (VL-AUC) — 19.94; 14.74; 16.44; 15.33 log10 copies-/ml*days — p=0.808

Summary

The primary objective of this study is to determine if a single intravenous (IV) dose of clesrovimab when administered at 1 of 4 dose levels results in a reduction in viral load after intranasal inoculation (with RSV A Memphis 37b) compared to IV placebo. It is hypothesized that at least 1 of the 4 dose levels of clesrovimab given prior to inoculation will reduce the area under the viral load-time curve (VL-AUC) from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40) compared to placebo.

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Viral Load-time Curve (VL-AUC)
19.94; 14.74; 16.44; 15.33; 21.25 0.808
SECONDARY
Percentage of Participants With Symptomatic Respiratory Syncytial Virus (RSV) Infection
53.85; 30.77; 35.71; 30.77; 53.33
SECONDARY
Number of Participants With an Adverse Event (AE)
11; 12; 12; 8; 11
SECONDARY
Number of Participants With a Serious Adverse Event (SAE)
0; 0; 0; 0; 0
SECONDARY
Serum Concentration of MK-1654
0.0369; 0.00; 0.00; 0.00; 16.4; 36.0
SECONDARY
Concentration of RSV Serum Neutralizing Antibody Titers
669.1; 699.3; 954.0; 893.8; 837.4; 11137.6

Eligibility Criteria

Inclusion Criteria

  • Is a male or female 18 to 55 years of age in good health with no history of major medical conditions that will interfere with participant safety, as defined by medical history, physical examination (including vital signs), electrocardiogram (ECG), and routine laboratory tests and determined by the Investigator at a screening evaluation.
  • Has a total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m^2 and ≤ 30kg/m^2.
  • If male, agrees to study contraceptive requirements at dosing and continuing until 90 days after dosing or 28 days after viral inoculation (whichever is later) and to not donate sperm until 90 days after dosing.
  • If female, has a negative pregnancy test at screening and prior to dosing and agrees to use one form of highly effective contraception if a woman of childbearing potential (WOCBP), or is not a WOCBP.
  • Has serology results within 90 days of dosing that suggest the participant is sensitive to RSV infection (i.e., that they are likely to become infected following inoculation).

Exclusion Criteria

  • Is a female who is breastfeeding or has been pregnant within 6 months prior to enrollment.
  • Has a history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immune suppression), metabolic, urological, renal, neurological, or psychiatric disease (including participants with a history of depression and/or anxiety with associated severe psychiatric comorbidities.
  • Has any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral inoculation (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded).
  • Has any clinically significant history of epistaxis (large nosebleeds) within the last 3 months prior to IMP dosing and/or history of being hospitalized due to epistaxis on any previous occasion.
  • Has a history or currently active symptoms suggestive of upper or lower respiratory tract infection within 6 weeks prior to dosing.
  • Has any other major disease that, in the opinion of the Investigator, may interfere with a participant completing the study and necessary investigations.
  • Has a history of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the investigator.
  • Has confirmed positive test for drugs of abuse prior to randomization.
  • Has a history or presence of alcohol addiction, or excessive use of alcohol (weekly intake in excess of 28 units alcohol; 1 unit being a half glass of beer, a small glass of wine or a measure of spirits), or excessive consumption of xanthine containing substances (e.g. daily intake in excess of 5 cups of caffeinated drinks e.g. coffee, tea, cola).
  • Is positive for human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test.
  • Has evidence of receipt of vaccine within the 4 weeks prior to IMP dosing.
  • Has intention to receive any vaccine(s) before the last day of Follow-up.
  • Receipt of blood or blood products, or loss (including blood donations) of 470 mL or more of blood during the 3 months prior IMP dosing or planned during the 3 months after the final visit.
  • Has use within 7 days prior to IMP dosing of any medication or product (prescription or over-the-counter), for symptoms of hay fever, dermatitis, nasal congestion or respiratory tract infections including the use of regular nasal or dermal corticosteroids or antibiotics, apart from those allowed in the study.
  • Has received systemic (intravenous and/or oral) glucocorticoids or systemic antiviral drugs within 6 months prior to IMP dosing.
  • Has received chronic (defined as more than 14 continuous days)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04086472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search