Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-8736 · 2 trials · 1 indication
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Cmax of ABBV-8736.
Tmax of ABBV-8736.
AUClast of ABBV-8736.
AUCinf of ABBV-8736.
β of ABBV-8736.
t1/2 of ABBV-8736.
CL of ABBV-8736.
Cmax of ABBV-8736.
Tmax of ABBV-8736.
AUCtau of ABBV-8736.
Ctrough of ABBV-8736.
β of ABBV-8736.
t1/2 of ABBV-8736.
CL for IV dosing.
Incidence and concentrations of ADAs. Neutralizing ADAs (NAb) may be evaluated.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Intravenous (IV) ABBV-8736 | EXPERIMENTAL | Participants will receive IV ABBV-8736 on Day 1. |
| Arm 2: Subcutaneous (SC) ABBV-8736 | EXPERIMENTAL | Participants will receive SC ABBV-8736 on Day 1. |
| Group 1: Dose A of ABBV-8736 | EXPERIMENTAL | Participants will receive intravenous (IV) ABBV-8736 dose A every 2 weeks for a total of 3 doses. |
| Group 1: Dose A of ABBV-8736 Placebo | PLACEBO_COMPARATOR | Participants will receive IV ABBV-8736 placebo dose A every 2 weeks for a total of 3 doses. |
| Group 2: Dose B of ABBV-8736 | EXPERIMENTAL | Participants will receive IV ABBV-8736 dose B every 2 weeks for a total of 3 doses. |
| Group 2: Dose B of ABBV-8736 Placebo | PLACEBO_COMPARATOR | Participants will receive IV ABBV-8736 placebo dose B every 2 weeks for a total of 3 doses. |
| Name | Type | Description |
|---|---|---|
| ABBV-8736 | DRUG | Intravenous Injection |
| Placebo | DRUG | IV Infusion |
Inclusion Criteria: * Body mass index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters. * Body weight \>= 35 kg. * A condition of general good health, based upon the results of a medical hi...
ABBV-8736 is an investigational small molecule being developed by AbbVie Inc. (ABBV). It is currently in Phase 1 clinical trials, which have been completed, involving healthy volunteers. The studies evaluate how the drug is tolerated and how it moves through the body when given as an intravenous infusion or subcutaneous injection.
ABBV-8736 is being studied in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics. It is not yet approved for any specific disease or condition. The completed Phase 1 trials focus on how the drug is absorbed and processed by the body, which is a standard step before testing in patient populations.
ABBV-8736 is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting the clinical trials for this investigational small molecule drug.
ABBV-8736 is in Phase 1 clinical development. Both of its clinical trials, which are now completed, were Phase 1 studies. The drug is investigational and has not been approved by regulatory authorities. It is being studied in healthy volunteers to assess safety, tolerability, and how the body processes the drug.
ABBV-8736 has two completed Phase 1 trials. NCT07141199 evaluated adverse events, tolerability, and drug movement after intravenous infusions in 24 healthy volunteers. NCT07413133 assessed how the body absorbs the drug from subcutaneous injections relative to intravenous injections in 40 healthy volunteers. Both were conducted in the United States.
No alternative names for ABBV-8736 have been disclosed. The drug is identified solely by its development code ABBV-8736 in the clinical trial records. It is an investigational small molecule and is not known to be marketed under any other name.