Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants
Purpose
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of NSHO-101 in Healthy Participants.
Condition
- Healthy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- To evaluate pharmacokinetics and safety of NSHO-101
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Cenexel Anaheim CA
Anaheim 5323810, California 5332921 92801
Anaheim 5323810, California 5332921 92801
More Details
- Status
- Recruiting
- Sponsor
- Ensho Therapeutics, Inc.