EP262 for Healthy Subjects

Overseen By Escient Clinical Trials

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Escient Pharmaceuticals, Inc

Disqualifiers: Malignancy, Allergic reactions, Bladder issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the body absorbs, processes, and eliminates a new oral treatment called EP262. Understanding the drug's behavior in the body is crucial for assessing its safety and effectiveness. This trial is suitable for healthy men who do not smoke, have a standard range body weight, and have no serious allergies or recent health conditions. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial organizers or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

A previous study tested EP262 on 64 healthy volunteers. The results showed that EP262 was safe and well-tolerated at all doses, with no serious or severe side effects reported. Some other studies suggest that there might be more side effects compared to some current treatments, but the safety data remains promising. Overall, based on the available research, EP262 appears to be safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for metabolic conditions, which typically involve lifestyle changes or medications designed to control symptoms, EP262 is unique because it offers a novel approach by exploring how the body absorbs, metabolizes, and excretes the compound. Researchers are excited about EP262 because it includes a [14C] labeling, allowing for precise tracking of the compound's journey through the body, providing insights into its potential effectiveness and safety profile. This detailed understanding could lead to more targeted and efficient treatments, potentially offering a new option for patients where existing therapies may fall short.

What evidence suggests that this treatment could be effective?

Research has shown that EP262, the investigational treatment in this trial, might help treat conditions like chronic hives and atopic dermatitis, a type of skin rash. EP262 blocks a specific receptor that activates mast cells, which are part of the immune system and can cause inflammation and allergic reactions. Early studies demonstrated that EP262 improved skin conditions and reduced signs of inflammation by inhibiting mast cell activity. Initial results also indicate that EP262 is safe and well-tolerated, even at high doses. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy male participants only. Specific eligibility criteria are not provided, but typically such studies require individuals to be within a certain age range and have no underlying health conditions.

Inclusion Criteria

I haven't used tobacco or nicotine products in the last 6 months.

My BMI is between 18 and 32, and my weight is between 55 to 100 kg.

I am a man between 18 and 55 years old.

Exclusion Criteria

History of any serious allergic reactions or hypersensitivity

I often wake up to urinate and feel my bladder doesn’t fully empty.

Usual habit of bowel movements of less than 1 or more than 3 bowel movements per day

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of [14C]-EP262 to assess mass balance, pharmacokinetics, and metabolite profiles

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, pharmacokinetics, and metabolite profiles after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EP262

Trial Overview The study is testing the absorption, metabolism, and excretion of a single oral dose of a drug called [14C]-EP262 in healthy men. It's an early-phase trial to understand how the body processes this medication.

How Is the Trial Designed?

Group I: [14C]-EP262 25 mg Experimental Treatment 1 Intervention

Administered orally.

EP262 is already approved in United States for the following indications:

Approved in United States as EP262 for:

• None approved yet; under investigation for chronic spontaneous urticaria, chronic inducible urticaria, and atopic dermatitis

Who Is Running the Clinical Trial?

Escient Pharmaceuticals, Inc

Lead Sponsor

Trials

6

Recruited

340+

Citations

1. escientpharma.com escientpharma.com/escient-pharmaceuticals-announces-positive-results-from-phase-1-study-of-ep262-a-first-in-class-oral-mrgprx2-antagonist-for-mast-cell-mediated-disorders/

Press Releases EP262 was safe and well-tolerated at all doses tested, at exposures several fold above doses required for efficacy in preclinical disease ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06645704?intr=ep262&rank=1

An Open-Label Phase 1 Study in Healthy Male Subjects to ... This study is being conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C]-EP262 in healthy male ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12010006/

Subnanomolar MAS-related G protein-coupled receptor-X2 ... The MRGPRX2 antagonist EP262 (INCB000262, structure undisclosed) was evaluated in a phase 2 clinical trial for the treatment of chronic ...

4. escientpharma.com escientpharma.com/escient-pharmaceuticals-initiates-clinical-proof-of-concept-study-of-ep262-a-first-in-class-oral-mrgprx2-antagonist-in-chronic-spontaneous-urticaria/

Press Releases EP262 has the potential to effectively treat multiple mast cell mediated diseases with an initial focus on chronic urticaria (hives) and atopic dermatitis ( ...

5. cell.com cell.com/trends/pharmacological-sciences/pdf/S0165-6147(24)00138-X.pdf

Advances in GPCR-targeted drug development in ... Preclinical studies indicate that. EP262 improves AD-like skin lesions and type 2 inflammatory biomarkers by blocking MRGPRX2 and mast cell degranulation, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06077773

Study Details | NCT06077773 | Phase 2, Multicenter, ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. escientpharma.com escientpharma.com/escient-pharmaceuticals-initiates-clinical-proof-of-concept-study-of-ep262-a-first-in-class-oral-mrgprx2-antagonist-in-chronic-inducible-urticaria/

Press Releases Study will evaluate EP262 in ~30 patients with symptomatic dermographism and cold urticaria using an open-label design and objective endpoints.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06144424?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Escient%20Pharmaceuticals,%20Inc%22)&viewType=Table&rank=2

Study Details | NCT06144424 | Phase 2a, Randomized, ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... EP262 150 mg, Intervention/Treatment, Drug : Oral EP262. Once daily. Participant ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0140673624008523

Chronic urticaria: unmet needs, emerging drugs, and new ... Safety data look promising even though adverse events appear more frequent than with omalizumab, the current standard therapy for moderate to ...