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Also known as FB102
FB102 Single dose · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| FB102 Single dose | EXPERIMENTAL | Part A (single ascending dose, SAD), FB102 will be administered as a single dose. |
| FB102 Multiple dose | EXPERIMENTAL | Part B (multiple ascending dose, MAD), FB102 will be administered once weekly for 4 doses. |
| FB102 Placebo | PLACEBO_COMPARATOR | The placebo will be administered on the same schedule as the corresponding FB-102 cohort. |
| Name | Type | Description |
|---|---|---|
| FB102 Single dose | DRUG | FB102 will be administered as a single dose |
| FB102 Multiple doses | DRUG | FB102 will be administered once weekly for 4 doses. |
| FB102 Placebo | DRUG | Matching placebo identical to FB102 formulation but without the active pharmaceutical ingredient |
Inclusion Criteria: 1. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at Screening. 2. Weight ≥50 kg and ≤100kg. 3. Men are required to agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm - verbal co...
FB102 is an investigational small molecule being developed for dermatologic and autoimmune conditions, including non-segmental vitiligo, severe to very severe alopecia areata, and celiac disease. It is also being studied in healthy volunteers to assess safety and effects. FB102 is currently in clinical development and is not yet approved by the FDA.
FB102 targets CD122, a protein that is part of the interleukin-2 receptor. By targeting CD122, FB102 is designed to modulate immune responses relevant to autoimmune diseases. This mechanism is being evaluated in clinical trials for conditions such as vitiligo, alopecia areata, and celiac disease.
FB102 is being developed by Forte Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker FBRX. The company is conducting clinical trials to evaluate the safety and efficacy of FB102 in multiple indications, including vitiligo, alopecia areata, and celiac disease.
FB102 is in Phase 1 and Phase 2 clinical development. Phase 1 trials are recruiting for vitiligo, alopecia areata, and healthy volunteer studies, while a Phase 2 trial is recruiting for celiac disease. FB102 has received Fast Track designation from the FDA, but it remains investigational and is not yet approved.
FB102 is being studied in four recruiting trials: NCT06905873, a Phase 1 study in non-segmental vitiligo (64 participants); NCT06982963, a Phase 2 study in celiac disease (100 participants); NCT07205159, a Phase 1 study in severe to very severe alopecia areata (32 participants); and NCT07623057, a Phase 1 study in healthy volunteers (48 participants).
Yes, FB102 is also known as FB102 Single dose. This alternative name may be used in some contexts to refer to the same investigational drug being developed by Forte Biosciences for conditions such as vitiligo, alopecia areata, and celiac disease.