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NCT Number: NCT07403552

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cenexel Anaheim CA

Anaheim, California, 92801, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NSHO-101

Drug

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

Primary outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax)

    Time frame: Day 1 to Day 18

  2. Pharmacokinetics: Area Under the Concentration Curve (AUC)

    Time frame: Day 1 to Day 18

  3. Pharmacokinetics: Trough Concentration (Ctrough)

    Time frame: Day 1 to Day 18

  4. Pharmacokinetics: Half-life

    Time frame: Day 1 to Day 18

  5. Pharmacokinetics: Time to Maximum Concentration (tmax)

    Time frame: Day 1 to Day 18

Secondary outcomes

  1. Treatment Emergent Adverse Events

    Time frame: Day 1 to 14

    Incidence of TEAEs

  2. Serious Treatment Emergent Adverse Events

    Time frame: Day 1 to Day 14

    Incidence of STEAEs

Study contacts

Contact information is provided by the study sponsor or research team.

Bittoo Kanwar, MD, MD

CONTACT

[email protected]

973-314-8995

Sponsors and collaborators

Lead sponsor

Ensho Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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