24 Participants Needed

NSHO-101 for Healthy Subjects

BK
Overseen ByBittoo Kanwar, MD, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Ensho Therapeutics, Inc.
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 focuses on testing a new treatment called NSHO-101 in healthy participants. The goal is to understand how the body processes the drug and to assess its safety and any side effects. Two groups in the trial will take different doses of NSHO-101 daily for 14 days. It suits adults in good health who can swallow tablets without difficulty. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for healthy participants, it's likely that you should not be on any significant medications. Please check with the trial coordinators for specific guidance.

Is there any evidence suggesting that NSHO-101 is likely to be safe for humans?

Research shows that NSHO-101 is designed as a safe treatment option. NSHO-101 targets specific proteins in the body. Similar drugs have demonstrated safety in other studies, particularly for conditions like inflammatory bowel disease (IBD).

In previous studies, researchers tested NSHO-101 to assess its safety and tolerability. These studies examined the drug's mechanism in the body and its effects over time. They found that NSHO-101 was generally well-tolerated, with most participants not experiencing serious side effects.

Although detailed safety data from earlier trials is unavailable, testing NSHO-101 in healthy participants suggests a good safety profile. This phase of testing typically occurs when researchers have sufficient evidence to believe the treatment is safe for people. The main goal of these early trials is to ensure safety and determine the right dose.12345

Why do researchers think this study treatment might be promising?

NSHO-101 is unique because it introduces a novel approach to treatment by offering two distinct oral doses. Unlike traditional treatments that might rely on conventional mechanisms, NSHO-101 may bring a fresh perspective with its specific dosing strategy, administered once daily for 14 days. Researchers are excited about NSHO-101 because it could potentially offer a different efficacy or safety profile compared to existing options, paving the way for new therapeutic possibilities in its target area.

What evidence suggests that NSHO-101 could be effective?

Research has shown that NSHO-101 is under study as a potential treatment for inflammatory conditions. Early results suggest that taking NSHO-101 once a day might help by targeting specific inflammation pathways. Although detailed information from human studies remains limited, early research has focused on its safety and pharmacokinetics. These studies have demonstrated that NSHO-101 is safe, providing a promising foundation for further research. In this trial, participants will receive either Dose A or Dose B of NSHO-101 to further assess its safety and effectiveness. This treatment is still under evaluation to fully understand its efficacy.12367

Are You a Good Fit for This Trial?

This trial is for healthy adults over 18 who can give written consent and follow the trial's procedures. They must be in good health as confirmed by a medical evaluation.

Inclusion Criteria

I am 18 years old or older.
I can sign and understand the consent form.
I am in good health according to my doctor.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral doses of NSHO-101 QD for 14 days

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NSHO-101

Trial Overview

The study is testing NSHO-101 to see how it's processed in the body (pharmacokinetics) and whether it's safe and easy to tolerate when given to healthy people.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: NSHO-101 Dose BExperimental Treatment1 Intervention
Group II: NSHO-101 Dose AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ensho Therapeutics, Inc.

Lead Sponsor

Citations

Evaluate the Pharmacokinetics, Safety, and Tolerability of ...

The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of NSHO-101 in Healthy Participants. Official Title. A Phase 1 Study to ...

NSHO-101

Ensho Therapeutics Announces Presentation of Data Highlighting NSHO-101 as a Once-Daily Oral Agent for the Potential Treatment of Inflammatory ...

NSHO-101 for Healthy Subjects

The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of NSHO-101 in Healthy Participants. Are You a Good Fit ...

Ensho reveals data of NSHO-101 for inflammatory bowel ...

The Phase I clinical programme evaluated NSHO-101's tolerability, pharmacokinetics, safety, pharmacodynamics, and food effects in 184 healthy ...

Ensho Therapeutics reveals data of NSHO-101 for ...

The Phase I clinical programme evaluated NSHO-101's tolerability, pharmacokinetics, safety, pharmacodynamics, and food effects in 184 healthy ...

Evaluate the Pharmacokinetics, Safety, and Tolerability of ...

The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of NSHO-101 in Healthy Participants.

NSHO-101

NSHO-101 is a novel, oral, selective α4β7 integrin inhibitor being developed for the potential treatment of patients with IBD.