Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PALI-2108 · 2 trials · 3 indications
Adverse events in FSCD patients receiving PALI-2108
Incidence of clinically significant laboratory abnormalities
Incidence of Treatment Emergent Adverse Events (TEAE) or abnormal clinical laboratory measure, electrocardiogram (ECG), or vital sign.
| Arm | Type | Description |
|---|---|---|
| FSCD Arm | EXPERIMENTAL | PALI-2108 All participants receive once-daily oral PALI-2108 for 14 days in the fed state. Two sentinel subjects receive a titrated regimen from 5 mg to 20 mg. After 7 days of sentinel dosing, the Safety Review Committee (SRC) reviews safety data and assigns the subsequent two patients to a target dose of 25 mg, with a predefined titration schedule. If the 25 mg dose is judged to be safe, all remaining subjects receive a target daily dose of 30 mg, also with a predefined titration scheme. Dose reductions may occur if safety profile is not judged adequate by SRC. Dosing is site-administered except on protocol-specified days when self-administration at home is permitted. |
| PALI-2108 | EXPERIMENTAL | Part A - Single Ascending oral doses of PALI-2108 in healthy adult subjects. Part B - Single oral dose crossover of PALI-2108 in healthy adult subjects. Part C - Multiple Ascending oral Doses of PALI-2108 in healthy adult subjects. Part D - (open-label) Multiple oral Doses of PALI-2108 in Ulcerative Colitis patients. |
| PALI-2108 Placebo | PLACEBO_COMPARATOR | Part A - Single Ascending oral Dose of matching placebo in healthy adult subjects. Part B - Single Ascending oral Dose of matching placebo crossover of PALI-2108 in healthy adult subjects. Part C - Multiple Ascending oral Doses of matching placebo in healthy adult subjects. Part D - (open-label) Multiple Ascending oral Doses of matching placebo in Ulcerative Colitis patients. |
| Name | Type | Description |
|---|---|---|
| PALI-2108 | DRUG | Oral PALI-2108 administered once daily for 14 days. Sentinel subjects titrate from 5 mg to 20 mg. Subsequent patients receive a target dose between 10-30 mg based on SRC review, following protocol-specified titration schedules. Dose reductions are permitted for safety. All doses are taken in the fed state. PALI-2108 is an oral, gut-activated PDE4 inhibitor prodrug designed to release its active metabolite (PALI-0008) locally via bacterial β-glucuronidase. This targeted delivery limits systemic exposure and reduces CNS-related effects associated with systemic PDE4 inhibitors, providing localized anti-inflammatory and anti-fibrotic activity in intestinal tissue. |
| PALI-2108 Placebo | DRUG | Oral dose |
Inclusion Criteria 1. Provision of signed and dated informed consent form (ICF) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Aged at least 18 years but not older than 60 years 4. Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, in...