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GUB014295 · 1 trial · 2 indications
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) ...
GUB014295 is an investigational small molecule being studied in healthy volunteers and overweight individuals. It is being evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics in a first-in-human trial. The drug is in the metabolic therapeutic area and is currently in Phase 1 clinical development.
GUB014295 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting a Phase 1 first-in-human study of the drug in healthy volunteers and overweight individuals.
GUB014295 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial has been completed, with results not yet publicly reported.
GUB014295 has one completed clinical trial, NCT06144684, titled "A Two-Part First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295." This Phase 1 study enrolled 76 participants in the United Kingdom, including healthy volunteers and overweight individuals.
Yes, the Phase 1 trial of GUB014295 (NCT06144684) was randomized, double-blind, and placebo-controlled. The study enrolled 76 participants, all aged 18 years and older, and included both healthy volunteers and overweight individuals. The trial was conducted in the United Kingdom.