NCT07403552

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
0mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

January 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

29 days

First QC Date

January 26, 2026

Last Update Submit

February 10, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • Pharmacokinetics: Maximum Concentration (Cmax)

    Day 1 to Day 18

  • Pharmacokinetics: Area Under the Concentration Curve (AUC)

    Day 1 to Day 18

  • Pharmacokinetics: Trough Concentration (Ctrough)

    Day 1 to Day 18

  • Pharmacokinetics: Half-life

    Day 1 to Day 18

  • Pharmacokinetics: Time to Maximum Concentration (tmax)

    Day 1 to Day 18

Secondary Outcomes (2)

  • Treatment Emergent Adverse Events

    Day 1 to 14

  • Serious Treatment Emergent Adverse Events

    Day 1 to Day 14

Study Arms (2)

NSHO-101 Dose A

EXPERIMENTAL

Oral dose A of NSHO-101 QD for 14 days

Drug: NSHO-101

NSHO-101 Dose B

EXPERIMENTAL

Oral dose B of NSHO-101 QD for 14 days

Drug: NSHO-101

Interventions

NSHO-101DRUG

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

NSHO-101 Dose ANSHO-101 Dose B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cenexel Anaheim CA

Anaheim, California, 92801, United States

RECRUITING

Central Study Contacts

Bittoo Kanwar, MD, MD

CONTACT

973-314-8995operations@enshorx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: To evaluate pharmacokinetics and safety of NSHO-101
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 11, 2026

Study Start

January 31, 2026

Primary Completion

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

US(1)