Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06652958 | A Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV | PHASE1 | ACTIVE NOT_RECRUITING | 102 | — | — | Oct 2, 2024 | Sep 9, 2026 | Mar 6, 2026 | 1 | United States |
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...