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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05653479 | Safety and Blood Levels After a Single Injection of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults | PHASE1 | COMPLETED | 32 | — | — | Dec 5, 2022 | May 13, 2023 | Sep 3, 2024 | 1 | United Kingdom |
Non-compartmental analysis was used for estimation of PK parameters.
Non-compartmental analysis was used for estimation of PK parameters.
Non-compartmental analysis was used for estimation of PK parameters. AUC = Area under the concentration-time curve
| Arm | Type | Description |
|---|---|---|
| Treatment Group 1 | EXPERIMENTAL | Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants |
| Treatment Group 2 | EXPERIMENTAL | Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants |
| Treatment Group 3 | EXPERIMENTAL | Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants |
| Treatment Group 4 | EXPERIMENTAL | Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants |
| Name | Type | Description |
|---|---|---|
| UPB-101 | DRUG | UPB-101 Subcutaneous injection |
Main Inclusion Criteria: 1. Male or female, aged ≥18 to ≤40 years at the date of signing informed consent 2. Body mass index (BMI) between 18 and 25 kg/m2 3. For Japanese (treatment groups 1, 2 and 3), participants must be: 1. Born in Japan, holding a Japanese passport, 2. Not living outside...