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...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Duvakitug, balinatunfib, Brivekimig |
| AbbVie, Inc. | ABBV | 16 | PHASE3 | Upadacitinib, Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736 |
| Eli Lilly and Company | LLY | 7 | PHASE3 | Mirikizumab, Tirzepatide, LY4395089, MORF-057 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 15 | PHASE3 | Vedolizumab, Zasocitinib, Darvadstrocel |
| Johnson & Johnson | JNJ | 24 | PHASE3 | Ustekinumab, Guselkumab, JNJ-78934804, Golimumab, Icotrokinra |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Spyre Therapeutics, Inc | SYRE | 2 | PHASE2 | SPY001, SPY002, SPY003 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Shattuck Labs, Inc. | STTK | 1 | PHASE2 | SL-325 |
| AgomAb Therapeutics NV ADR | AGMB | 2 | PHASE2 | Ontunisertib |
| Hoffmann-La Roche | RHHBY | 1 | PHASE2 | Afimkibart |
| Pfizer Inc. | PFE | 1 | PHASE2 | Etrasimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
ABBV-8736 is an investigational small molecule being developed by AbbVie Inc. for the treatment of Crohn's disease. It is in Phase 1 clinical development and has been studied in healthy adult volunteers. It has not been approved by the FDA.
ABBV-8736 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical trials evaluating the drug.
ABBV-8736 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both in healthy adult volunteers, and no active trials are currently listed. It remains an investigational drug and is not FDA approved.
Two completed Phase 1 trials have evaluated ABBV-8736. NCT07413133 assessed how the body absorbs subcutaneous injections relative to intravenous injections in 40 healthy volunteers. NCT07141199 evaluated adverse events, tolerability, and how intravenous infusions of the drug move through the body in 24 healthy volunteers. Both were conducted in the United States.
ABBV-8736 is being developed for the treatment of Crohn's disease, a chronic inflammatory condition of the digestive tract. The completed Phase 1 trials enrolled healthy volunteers rather than Crohn's disease patients, so the drug remains in early clinical development for this indication.
The two completed Phase 1 trials of ABBV-8736 enrolled a total of 64 participants. NCT07413133 enrolled 40 healthy volunteers and NCT07141199 enrolled 24 healthy volunteers. Both studies were randomized, double-blind, and controlled, and both enrolled adults aged 18 years and older.