Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of NSHO-101 in Healthy Participants.
Interventions
DRUGNSHO-101
Dose form - tablet Route of administration - oral Regimen / Treatment period - QD for 14 days
Sponsors
Ensho Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
To evaluate pharmacokinetics and safety of NSHO-101
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events | Day 1 to 14 | Incidence of TEAEs |
| Serious Treatment Emergent Adverse Events | Day 1 to Day 14 | Incidence of STEAEs |
Countries
United States
Contacts
CONTACTBittoo Kanwar, MD, MD
Outcome results
None listed