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PDE4 Inhibitor

PALI-2108 for Ulcerative Colitis

Phase 1

Recruiting

Led By Mitchell L Jones, MD, PhD

Research Sponsored by Palisade Bio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If male, meets criteria for procreation and contraceptive use or is surgically sterile

If female, is of non-childbearing potential through surgical sterilization or postmenopausal state

Must not have

History of renal disease

Active infection or recent history of serious infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up sad and fe phase: [ day 1 to day 7 ], mad and uc phase: [ days 1 to day 28 ]

Summary

This trial is testing a new oral medication, PALI-2108, for treating ulcerative colitis (UC). The medication targets the intestines and becomes active in the colon, reducing the risk

Who is the study for?

This trial is for healthy volunteers and stable ulcerative colitis (UC) patients. Participants should be adults who can take oral medication. The study excludes individuals with other significant health issues, those on certain medications that might interfere with the trial, or anyone unable to comply with study requirements.

What is being tested?

PALI-2108, a new oral drug targeting UC by becoming active in the colon, is being tested for safety and how it's processed by the body. Healthy participants will first receive single doses; then they'll take it twice daily for a week. A small group of UC patients will do the same to compare results.

What are the potential side effects?

As PALI-2108 is new and targets only the colon to reduce side effects common in full-body treatments, specific side effects are unknown but may include typical drug reactions like digestive discomfort or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man who either uses contraception or am surgically sterile.

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I am a woman who cannot become pregnant due to surgery or being postmenopausal.

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of kidney disease.

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I do not have an active infection or a recent history of serious infections.

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I have not had major surgery in the last 4 weeks.

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I have had tuberculosis in the past.

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I have recently taken PALI-2108 or another investigational drug.

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I am currently pregnant or breastfeeding.

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I have or had serious stomach, liver, or kidney disease.

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I have not received a live vaccine in the last 4 weeks.

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I am not on maintenance therapy and have no history of drug or alcohol abuse.

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I have UC and have failed biologic treatments or used them recently, and may have had specific surgeries or liver issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ sad and fe phase: [ day 1 to day 7 ], mad and uc phase: [ days 1 to day 28 ]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~sad and fe phase: [ day 1 to day 7 ], mad and uc phase: [ days 1 to day 28 ]

This trial's timeline: 3 weeks for screening, Varies for treatment, and sad and fe phase: [ day 1 to day 7 ], mad and uc phase: [ days 1 to day 28 ] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events (TEAE) or abnormal clinical laboratory measure, electrocardiogram (ECG), or vital sign. [ Safety and Tolerability ]

Secondary study objectives

Area Under the Curve from dosing to the time of the last measured concentration (AUC0-12)

Area Under the Curve from dosing to the time of the last measured concentration (AUC0-T)

Area under the curve from time 0 extrapolated to infinite time (AUC0-12)

+16 more

Other study objectives

Colonic tissue drug concentration (Ctissue) in MAD and UC

Cyclic adenosine monophosphate (cAMP) in MAD and UC

Mean change in Geboes Score in UC cohort.

+7 more

Side effects data

From 2007 Phase 4 trial • 417 Patients • NCT00233064

Bronchiolitis

Viral Infection

Gastroenteritis

100%

80%

60%

40%

20%

Study treatment Arm

Liquid Palivizumab

Lyophilized Palivizumab

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PALI-2108Experimental Treatment1 Intervention

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.

Group II: PALI-2108 PlaceboPlacebo Group1 Intervention

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.

0 / 13Eligibility criteria met