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VH4527079 · 1 trial · 1 indication
An AE is 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. Severity of AEs will be assessed using Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life threatening and Grade 5=Death.
| Arm | Type | Description |
|---|---|---|
| Arm A, Cohort 1 | EXPERIMENTAL | Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by IV infusion. |
| Arm A, Cohort 2 | EXPERIMENTAL | Healthy adult participants receive a single dose of VH4527079 Dose 2 (low dose) by IV infusion. |
| Arm A, Cohort 3 | EXPERIMENTAL | Healthy adult participants receive a single dose of VH4527079 Dose 3 (mid-low dose) by IV infusion. |
| Arm A, Cohort 4 | EXPERIMENTAL | Healthy adult participants receive a single dose of VH4527079 Dose 4 (mid-high dose) by IV infusion. |
| Arm A, Cohort 5 | EXPERIMENTAL | Healthy adult participants receive a single dose of VH4527079 Dose 5 (high dose) by IV infusion. |
| Arm A, Cohort 6 | EXPERIMENTAL | Healthy adult participants receive a single dose of VH4527079 Dose 6 (max dose) by IV infusion. |
| Arm A, Cohort 7 | EXPERIMENTAL | Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by SC injection. |
| Arm B, Cohort 8 | EXPERIMENTAL | Healthy adult participants receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval. |
| Arm B, Cohort 9 | EXPERIMENTAL | Participants with HIV receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval. |
| Name | Type | Description |
|---|---|---|
| VH4527079 | BIOLOGICAL | VH4527079 solution for injection or infusion will be administered either by SC injection or IV infusion respectively. |
Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent. * Participants who are overtly healthy based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Participants who a...
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VH4527079 is an investigational human monoclonal antibody being studied for the treatment of HIV infections. It is currently in Phase 1 clinical development, with a trial assessing its safety and pharmacokinetics in healthy adults and persons with HIV.
VH4527079 is a human monoclonal antibody, but its specific molecular target has not been disclosed. It is being studied for its potential role in managing HIV infections, though the exact mechanism of action is not publicly detailed.
VH4527079 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational monoclonal antibody.
VH4527079 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess its safety and pharmacokinetics in healthy adults and persons with HIV.
VH4527079 is being evaluated in a Phase 1 clinical trial registered as NCT06652958. This study, titled 'A Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV,' is active but not recruiting participants, with an enrollment of 102 individuals in the United States.
No alternative names for VH4527079 have been disclosed. It is identified solely by its code name VH4527079 in clinical trial registries and development programs.