Testing NSHO-101 safety and how the body processes it in healthy adults

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

This trial will test whether NSHO-101 is safe and how the body absorbs, distributes, metabolizes, and clears it in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ensho Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (Anaheim, California)
• Trial ID: NCT07403552 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional trial gives NSHO-101 to healthy adult volunteers to measure pharmacokinetics, safety, and tolerability. Participants will be screened, receive one or more planned doses under medical supervision, and undergo serial blood sampling and physical exams to track drug levels and any adverse events. Safety monitoring will include vital signs, clinical laboratory tests, and recording of side effects during and after dosing. The data will define initial PK profiles and tolerability to guide dosing in later patient-focused trials.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 or older who can give informed consent, have no significant medical conditions, and can comply with trial procedures.

Not a fit: People with active medical illnesses, a history of drug hypersensitivity, difficulty swallowing pills, pregnant or breastfeeding individuals, or those expecting direct therapeutic benefit are unlikely to gain clinical benefit from participation.

Why it matters

Potential benefit: If results are favorable, the trial could identify safe dosing and pharmacokinetic data needed to advance NSHO-101 into patient trials that might lead to new therapies.

How similar studies have performed: Phase 1 PK and safety studies in healthy volunteers are a standard, often-successful first step for new drugs, though NSHO-101 itself appears to have no publicly reported prior human data.

Eligibility criteria

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.

Where this trial is running

Anaheim, California

• Cenexel Anaheim CA — Anaheim, California, United States (Recruiting)

Study contacts

• Study coordinator: Bittoo Kanwar, MD, MD

Conditions Healthy