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

Ensho Therapeutics, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: NSHO-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT07403552

NSHO-101-HV202

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

NSHO-101 Dose A

Experimental group

Description:

Oral dose A of NSHO-101 QD for 14 days

Treatment:

Drug: NSHO-101

NSHO-101 Dose B

Experimental group

Description:

Oral dose B of NSHO-101 QD for 14 days

Treatment:

Drug: NSHO-101