Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RV16UB · 1 trial · 1 indication
ECI are selected non-serious and serious adverse events which include the following: an overdose of Sponsor's product; requirement for systemic steroids to treat asthma exacerbation related to virus challenge; acute reaction to virus challenge, confirmed through repeat measurement and when considered potentially associated with administration of virus; specified vital sign findings within 4hr of challenge; specified symptom findings within 24hr of challenge; \>20% decrease in Forced Expiratory Volume in 1 second (FEV1) relative to baseline within 4hr of challenge; dyspnea associated with drop in FEV1 (within 4hr of challenge) that is unresponsive to a bronchodilator rescue agent within 20 minutes; Grade 2+ deviation from normal values of liver-related laboratory parameters at any time between challenge and day 14.
A SAE is any adverse event occurring at any dose or during any use of the Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing in-patient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.
Asthmatic participants from Part 1 were treated with RV16UB virus at a dose of 100 TCID50, and challenge induced upper airway symptoms were monitored with a diary recording Jackson Cold Symptom Score (CSS). The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity. The number of participants with a CSS score equal or greater than 3 for two days in a row are presented.
Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 am to 3 pm were counted as morning measurements. The TWA CFB morning FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 morning FEV1 value and the corresponding estimated baseline value. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%.
Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 pm to next day 3 am were counted as evening measurements. The TWA CFB evening FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 evening FEV1 value and the corresponding estimated baseline value. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%.
Asthmatic participants from Part 1 were treated with RV16UB virus, and challenge induced upper airway symptoms were monitored with a diary recording CSS. The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity, and a positive change from baseline indicating worsening symptoms.
Viral RNA was measured by real time reverse transcriptase polymerase chain reaction (qRT-PCR) from nasal lavage fluid collected on day 3 and day 7 from asthmatic participants, and the number of participants with at least 10\^3 copies/ml was determined.
| Arm | Type | Description |
|---|---|---|
| Healthy 10 TCID50 (Part 1) | EXPERIMENTAL | Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| Healthy 100 TCID50 (Part 1) | EXPERIMENTAL | Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| Healthy 1000 TCID50 (Part 1) | EXPERIMENTAL | Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| Asthmatic non-LABA 10 TCID50 (Part 1) | EXPERIMENTAL | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| Asthmatic non-LABA 100 TCID50 (Part 1) | EXPERIMENTAL | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| Asthmatic LABA 100 TCID50 (Part 1) | EXPERIMENTAL | Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| Asthmatic non-LABA 100 TCID50 (Part 2) | EXPERIMENTAL | Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril. |
| Name | Type | Description |
|---|---|---|
| RV16UB | BIOLOGICAL | RV16UB is administered by spraying an atomized viral suspension into a single nostril. Planned doses of RV16UB in Part 1 are 10 Tissue Culture Infective Dose 50 (TCID50), 100 TCID50, 1000 TCID50 and 10,000 TCID50. |
| LABA | DRUG | Asthmatic participants were treated with LABA as part of their standard of care |
Inclusion Criteria: Parts 1 and 2: * have a Body Mass Index (BMI) between =\< 35 kg/m\^2 and \> 17 kg/m\^2 * female of childbearing potential is not pregnant and agrees to use 2 acceptable methods of birth control until 10 days after the last visit,; or female is of non-childbearing potential * is...
RV16UB is an investigational monoclonal antibody being studied for use in asthma. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being evaluated for its safety and potential effects in healthy and asthmatic participants.
RV16UB is a monoclonal antibody, which is a type of biologic drug designed to bind to a specific target in the body. However, the specific molecular target of RV16UB has not been disclosed in available information. The drug is being studied for its role in asthma, a respiratory condition.
RV16UB is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical research to evaluate the safety and use of RV16UB in asthma.
RV16UB is in Phase 1 clinical development. This is the earliest stage of testing in humans, focused primarily on assessing the drug's safety, tolerability, and how it behaves in the body. The drug is investigational and has not been approved by regulatory authorities.
RV16UB has been studied in one clinical trial with the identifier NCT01866306, titled "A Study to Evaluate the Safety and Use of Human Rhinovirus in Healthy and Asthmatic Participants (MK-0000-218)." This Phase 1 trial has been completed and enrolled 59 participants, including healthy volunteers and individuals with asthma.
RV16UB is associated with the clinical trial identifier MK-0000-218, which appears in the trial title. However, MK-0000-218 is the trial's internal code, not an alternative name for the drug itself. RV16UB is the drug name used in the study.