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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07525544 | A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants | PHASE1 | NOT YET_RECRUITING | 214 | — | — | Apr 7, 2026 | May 5, 2027 | Apr 13, 2026 | - | — |
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The AEs are graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria where grades are defined based on numeric criteria as follows Grade 3: severe symptoms; Grade 4: potentially life-threatening. A higher grade indicates greater severity.
| Arm | Type | Description |
|---|---|---|
| Part A: VH4770359 SAD group | EXPERIMENTAL | Healthy participants will receive a single dose of VH4770359 on Day 1. Up to 7 cohorts will receive single ascending doses (SAD). |
| Part A: Placebo SAD group | PLACEBO_COMPARATOR | Healthy participants will receive a single dose of Placebo on Day 1. |
| Part B: VH4770359 MAD group | EXPERIMENTAL | Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Up to 4 cohorts will receive multiple ascending doses (MAD). |
| Part B: Placebo MAD group | PLACEBO_COMPARATOR | Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. |
| Part B: VH4770359 MAD Drug-Drug Interaction (DDI) group | EXPERIMENTAL | Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14. |
| Part B: Placebo MAD DDI group | PLACEBO_COMPARATOR | Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14. |
| Name | Type | Description |
|---|---|---|
| VH4770359 | DRUG | Participants will receive the assigned dose formulation of VH4770359 orally. |
| Placebo | DRUG | Participants will receive placebo to match the VH4770359 dose formulation. |
| Midazolam | DRUG | Participants receive 2 mg Midazolam on Days -1, Day 1 and Day 14. |
Inclusion Criteria: 1. 18 to 55 years old 2. BMI 18.5-37.0 kg/m2 3. Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant/breastfeeding and be of non-childbearing potential. Exclusion Criteria: 1. Participants with significant medi...