Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lutikizumab Dose A · 1 trial · 1 indication
Cmax of lutikizumab will be assessed.
Tmax of lutikizumab will be assessed.
Apparent terminal phase elimination rate constant (β) of lutikizumab will be assessed.
Terminal phase elimination half-life (t1/2) of lutikizumab will be assessed.
AUC0-t of lutikizumab will be assessed.
AUC0-inf of lutikizumab will be assessed.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Part 1, Dose A | EXPERIMENTAL | Participants will receive a single dose of Lutikizumab Dose A. |
| Part 1, Dose B | EXPERIMENTAL | Participants will receive a single dose of Lutikizumab Dose B. |
| Part 2 | EXPERIMENTAL | Han Chinese participants will receive a single dose of Lutikizumab. |
| Name | Type | Description |
|---|---|---|
| Lutikizumab Dose A | DRUG | Injection; subcutaneous (SC) |
| Lutikizumab Dose B | DRUG | Injection; subcutaneous (SC) |
Inclusion Criteria: * Male and female healthy volunteers aged between 18 and 60 years. \-- Part 2 only: Participant must be first-generation Han Chinese of full Chinese parentage residing outside of China. Participant must maintain a typical Chinese lifestyle, including consuming a typical Chine...
Lutikizumab Dose A is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its relative bioavailability, pharmacokinetics, safety, and tolerability in Chinese participants.
Lutikizumab Dose A is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical research on this investigational small molecule in healthy volunteers.
Lutikizumab Dose A is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under clinical investigation for use in healthy volunteers.
Lutikizumab Dose A has one completed clinical trial, identified as NCT06067568. This Phase 1 study evaluated the relative bioavailability of two Lutikizumab formulations and the pharmacokinetics, safety, and tolerability of Lutikizumab in Chinese participants, enrolling 50 healthy volunteers in the United States.
Lutikizumab Dose A is a specific dose or formulation of the investigational drug Lutikizumab. The completed clinical trial NCT06067568 compared two Lutikizumab formulations, indicating that Lutikizumab Dose A is one of the formulations being studied for relative bioavailability.