Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VAL-181388 · 1 trial · 1 indication
Solicited AEs, including local and systemic AEs were recorded by participants daily using the memory aid. Solicited local AEs include injection site induration/swelling, injection site tenderness, injection site erythema/redness, and injection site pain. Solicited systemic AEs include body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, and diarrhea. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
| Arm | Type | Description |
|---|---|---|
| VAL-181388 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| VAL-181388 | BIOLOGICAL | Escalating dose levels |
| Placebo | OTHER | Saline |
Inclusion Criteria: * 18 to 49 years of age * Body mass index between 18 and 35 kilograms (kg)/square meter (m\^2) * In good health as determined by medical history * Female participants must be non pregnant and non lactating and meet one of the following criteria: a) post menopausal b) surgically ...
VAL-181388 is an investigational monoclonal antibody being developed for the prevention or treatment of Chikungunya virus infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
VAL-181388 is being developed by Moderna, Inc. (NASDAQ: MRNA). The company is conducting clinical trials to evaluate the safety, tolerability, and immunogenicity of this investigational monoclonal antibody.
VAL-181388 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it has not yet received regulatory approval for any use.
VAL-181388 has been studied in one completed Phase 1 trial (NCT03325075), which evaluated its safety, tolerability, and immunogenicity in 60 healthy participants in the United States. The trial was randomized, double-blind, and placebo-controlled.
No, VAL-181388 is a monoclonal antibody, not a vaccine. It is designed to target the Chikungunya virus directly, whereas a vaccine would stimulate the immune system to produce its own antibodies. The drug is being studied for its potential to prevent or treat infection.