INCB000631 for Safety in Healthy Adults

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: Antibiotics, Antifungals, Antivirals, others

Disqualifiers: Cardiovascular, Hypertension, Malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 18 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and metabolism of a new oral treatment called INCB000631 in healthy adults. Researchers aim to understand the drug's safety and how the body absorbs and processes it. Participants may receive either the actual medication or a placebo (a harmless pill without active ingredients) for comparison. Healthy adults who can swallow tablets and are willing to avoid pregnancy during the trial may be suitable candidates. 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?

Yes, you will need to stop taking prescription drugs within 14 days and nonprescription medications within 7 days before starting the study drug, except for occasional acetaminophen and standard-dose vitamins.

Is there any evidence suggesting that INCB000631 is likely to be safe for humans?

Research shows that INCB000631 is under study to assess its safety in people. As a Phase 1 trial, the primary goal is to evaluate the drug's safety and tolerability. In similar studies, researchers have closely monitored participants for side effects. Although detailed results from these studies are not yet available, reaching this phase suggests that INCB000631 has passed initial lab safety tests. This indicates it might be safe enough for human trials, but researchers must confirm this by monitoring for any adverse reactions. Participants should be aware that this is an early-stage trial, so understanding the potential risks is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about INCB000631 because it offers a fresh approach compared to current treatments for similar conditions. Unlike standard treatments that often rely on traditional pathways, INCB000631 works by targeting a novel mechanism that could potentially lead to better outcomes. Additionally, it is being tested both as a standalone treatment and in combination with a placebo, providing insights into its effectiveness and safety. This innovative approach could pave the way for more effective and tailored therapies in the future.

What evidence suggests that INCB000631 could be effective?

Research on INCB000631 remains in the early stages. This trial will test INCB000631 to understand its mechanism in the body, its safety, and its tolerability. Although limited information exists on its effectiveness for specific conditions, scientists remain hopeful due to its unique interaction with the body. The goal is to learn more about the drug's behavior in healthy adults, which will guide future studies. This foundational research is crucial for determining its potential as a treatment. ^{1 2 3 4 5}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for healthy adults who can safely participate in a study to test a new medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Body mass index between 18.0 and 32.0 kg/m2 at screening

No clinically significant findings on screening evaluations (clinical, laboratory except lipids, and ECG)

I agree to follow the study's rules about preventing pregnancy or fathering children.

Exclusion Criteria

History of an autoimmune disease such as myasthenia gravis

I have a history of heart, brain, or blood vessel diseases, or my high blood pressure is not under control.

High blood pressure at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB000631 or placebo at the protocol-defined dose based on cohort assignment

Up to 18 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2.5 months

What Are the Treatments Tested in This Trial?

Interventions

• INCB000631

Trial Overview The trial is testing the safety, how well tolerated it is, and how the body processes INCB000631 when taken by mouth compared to a placebo (a substance with no active drug).

How Is the Trial Designed?

Group I: Cohort D Treatment B Experimental Treatment 2 Interventions

INCB000631 or placebo will be administered at the protocol defined dose based on cohort assignment.

Group II: Cohort D Treatment A Experimental Treatment 2 Interventions

INCB000631 or placebo will be administered at the protocol defined dose based on cohort assignment.

Group III: Cohort C Treatment B Experimental Treatment 2 Interventions

INCB000631 or placebo will be administered at the protocol defined dose based on cohort assignment.

Group IV: Cohort C Treatment A Experimental Treatment 2 Interventions

INCB000631 or placebo will be administered at the protocol defined dose based on cohort assignment.

Group V: Cohort B Experimental Treatment 2 Interventions

INCB000631 or placebo will be administered at the protocol defined dose based on cohort assignment.

Group VI: Cohort A Experimental Treatment 2 Interventions

INCB000631 or placebo will be administered at the protocol defined dose based on cohort assignment.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07039929

NCT07039929 | Study to Assess the Safety, Tolerability ... This study will be conducted to assess the safety, tolerability, and pharmacokinetics of INCB000631 when administered orally to healthy adult participants.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06775327

NCT06775327 | Study to Assess Safety, Tolerability ... This study will be conducted to assess the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics, and Food Effect of INCB000631 When Administered Orally ...

3. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-6-2025-3d770

INCB000631 for Safety in Healthy Adults · Info for Participants This study will be conducted to assess the safety, tolerability, and pharmacokinetics of INCB000631 when administered orally to healthy adult participants. Show ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/INCY/pressreleases/35739436/incytes-new-phase-1-study-a-potential-game-changer/

Incyte's New Phase 1 Study: A Potential Game-Changer? The primary goal is to evaluate the safety and tolerability of the drug INCB000631 in healthy adults, which is crucial for its potential future ...

5. tipranks.com tipranks.com/news/company-announcements/incytes-new-study-on-incb000631-a-potential-game-changer

Incyte's New Study on INCB000631: A Potential Game ... ' The study aims to evaluate the safety, tolerability, and pharmacokinetics of the drug INCB000631 in healthy adults, marking a significant step ...