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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06144684 | A Two-Part First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295 | PHASE1 | COMPLETED | 76 | — | — | Nov 29, 2023 | Jan 5, 2026 | Jan 15, 2026 | 1 | United Kingdom |
To provide safety information for GUB014295 by assessing: incidence of AEs categorized in System Organ Class (SOC) according to MedDRA (and evaluating severity and duration for SOC). No formal hypothesis will be tested in the study. Descriptive summaries for all safety safety data for all placebo, each active treatment and all active will be provided (including changes from baseline)
To provide safety information for GUB014295 by assessing: Any changes from baseline for vital signs including: Blood pressure, Pulse/heart rate, oral temperature and respiratory frequency summarized as a ratio (baseline/end of trial). No formal hypothesis will be tested in the study. Descriptive summaries (as a relative change (ratio: 0 - 1) from day 0 to end of trial) for all safety safety data for all placebo, each active treatment and all active will be provided.
To provide safety information for GUB014295 by assessing a wide range of laboratory parameters within hematology, coagulation, clinical chemistry, virology, urinalysis. No formal hypothesis will be tested in the study. Descriptive summaries (as a relative change (ratio: 0 - 1) from day 0 to day end of trial)) for all safety safety data for all placebo, each active treatment and all active will be provided.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | placebo solution |
| GUB014295 | ACTIVE_COMPARATOR | GUB014295 solution 5 mg/mL |
| Name | Type | Description |
|---|---|---|
| GUB014295 | DRUG | GUB014295 is a long-acting amylin analogue in development, a single subcutaneous dose is administered in part 1, multiple doses administered in part 2 of the study |
| GUB014295-PLACEBO | DRUG | GUB014295-PLACEBO is matching GUB014295 in appearance, a single subcutaneous dose is administered in part 1, multiple doses administered in part 2 of the study |
Inclusion Criteria: * Males (Part 1 only) aged 18 to 55 years, and males and females (Part 2 only) aged 18 to 65 years inclusive at the time of signing informed consent * Must agree to adhere to the contraception requirements * Lean to overweight or obese but otherwise healthy males (Part 1 and 2) ...