Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants

February 10, 2026 updated by: Ensho Therapeutics, Inc.

A Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • Cenexel Anaheim CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants (males and females) at least 18 years of age
  • Ability to provide written informed consent
  • In good heath as determined by medical evaluation,
  • Willing and able to comply with trial restrictions, procedures, and requirements

Exclusion Criteria:

  • Known sensitivity to any components of the IMP
  • History of relevant drug hypersensitivity
  • Presents or has a history of clinically significant diseases
  • History of difficulty swallowing tablets or capsules.
  • Any physical examination findings or medical history that might place the participant at an unacceptable risk for participation in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSHO-101 Dose A
Oral dose A of NSHO-101 QD for 14 days
Drug: NSHO-101
Dose form - tablet Route of administration - oral Regimen / Treatment period - QD for 14 days
Experimental: NSHO-101 Dose B
Oral dose B of NSHO-101 QD for 14 days
Drug: NSHO-101
Dose form - tablet Route of administration - oral Regimen / Treatment period - QD for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: Maximum Concentration (Cmax)
Time Frame: Day 1 to Day 18
Day 1 to Day 18
Pharmacokinetics: Area Under the Concentration Curve (AUC)
Time Frame: Day 1 to Day 18
Day 1 to Day 18
Pharmacokinetics: Trough Concentration (Ctrough)
Time Frame: Day 1 to Day 18
Day 1 to Day 18
Pharmacokinetics: Half-life
Time Frame: Day 1 to Day 18
Day 1 to Day 18
Pharmacokinetics: Time to Maximum Concentration (tmax)
Time Frame: Day 1 to Day 18
Day 1 to Day 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Emergent Adverse Events
Time Frame: Day 1 to 14
Incidence of TEAEs
Day 1 to 14
Serious Treatment Emergent Adverse Events
Time Frame: Day 1 to Day 14
Incidence of STEAEs
Day 1 to Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ensho Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 31, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • NSHO-101-HV202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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