Recruiting
Phase 1

NSHO-101

Sponsor:

Ensho Therapeutics, Inc.

Code:

NCT07403552

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

NSHO-101

Study Details

Brief summary:

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

Conditions

Healthy

Study ID

NCT07403552

Start date

Jan 31, 2026

Status verified date

Feb, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: NSHO-101 Dose A

Oral dose A of NSHO-101 QD for 14 days

experimental: NSHO-101 Dose B

Oral dose B of NSHO-101 QD for 14 days

Interventions

NSHO-101

Dose form - tablet Route of administration - oral Regimen / Treatment period - QD for 14 days

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Bittoo Kanwar, MD, MD

973-314-8995operations@enshorx.com

Locations

Cenexel Anaheim CA

Recruiting

Anaheim, California, United States, 92801

More Information

Sponsor

Ensho Therapeutics, Inc.

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ensho Therapeutics, Inc. on 2026-02-11.