JPH034 for Healthy Adults

Overseen ByMasuhiro Yoshitake

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: J-Pharma Co., Ltd.

Must not be taking: QT-prolonging drugs

Disqualifiers: Cardiovascular, Psychiatric, Liver disease, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and side effects of a new drug, JPH034, in healthy adults. Participants will receive either a dose of JPH034 or a placebo, with some tested to see how food affects the drug. As a first-phase trial, this marks the first time JPH034 is tested in humans. It suits healthy individuals without major illnesses, recent infections, or recent use of certain medications. Participants in this Phase 1 trial have the unique opportunity to be among the first to receive this new treatment and contribute to understanding its effects in people.

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

Yes, you must stop taking any prescription or non-prescription medications at least 14 days before the first dose of the study drug.

Is there any evidence suggesting that JPH034 is likely to be safe for humans?

Research has shown that JPH034 underwent testing in healthy volunteers previously. These studies focused on safety and tolerability, assessing how well participants handled the treatment and whether it caused any side effects. The results indicated that JPH034 met its safety goals, suggesting it was generally well-tolerated.

Since the current trial is in its first phase, it marks the initial step in testing a new treatment in humans. This stage closely monitors safety in a small group. While initial findings are promising, ongoing trials will offer more detailed safety information.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Researchers are excited about JPH034 because it offers a potentially new way to address conditions that require careful dose exploration. Unlike existing treatments that often follow a one-size-fits-all approach, JPH034 is being tested across various dosages, from 20mg to 160mg, to determine the most effective and safe concentration. This tailored dosage approach could lead to more personalized treatment options, minimizing side effects while maximizing benefits. Additionally, there is a focus on understanding the impact of food on the drug's effectiveness, which could further refine how and when the medication is best taken. These features could represent a significant step forward in creating more targeted and efficient treatments.

What evidence suggests that JPH034 could be effective?

Research on JPH034 currently focuses on understanding how the drug works in healthy adults. No solid evidence yet supports its effectiveness for any specific condition. So far, researchers have concentrated on safety, tolerance, and the drug's movement through the body. As the treatment remains in the early stages, the primary focus is on its effects and any side effects. Future studies will need to explore its potential benefits for treating specific health issues.¹ ² ⁶ ⁷ ⁸

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 50 with normal kidney and liver function, a BMI between 18.5 and 34, no recent illnesses or infections, not pregnant (for women), negative drug/alcohol tests, and willing to use contraception. People with certain medical conditions or abnormal lab results cannot join.

Inclusion Criteria

I am between 18 and 50 years old.

I am female and have tested negative for pregnancy before starting the study.

Negative drug/alcohol testing at Screening and Check-in

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Exclusion Criteria

I have had an active infection in the past 14 days.

I have not had any serious illness in the past 30 days.

Elevated ALT or AST levels

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Single-Ascending Dose (SAD)

Participants receive a single dose of JPH034 or placebo under fasted conditions, with safety and PK assessments

9 days

In-clinic stay from Day -1 to Day 3, with follow-up visits on Days 4, 5, and 9

Pilot Food Effect (FE)

Participants from selected SAD cohort receive a single dose of JPH034 in a fed state to evaluate the effect of food on PK

9 days

In-clinic stay from FE Day -1 to FE Day 3, with follow-up visits on FE Days 4, 5, and 9

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

JPH034

Trial Overview

The study is testing the safety and how the body processes a new drug called JPH034 compared to placebo in healthy adults. Participants are randomly assigned to receive either JPH034 or placebo once; some will get an extra dose after eating to see if food affects the drug.