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A Phase I Study of NS-079 in Healthy Participants

NCT07669571 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-07-30

No results posted yet for this study

Summary

The goal of this clinical trial is evaluate the safety, pharmacokinetics, and pharmacodynamics of NS-079 with its main metabolite (NS-079-M1) in healthy participants. The main questions it aims to answer are:

* Is NS-079 safe and tolerable in heathy participants under tested dosing regimen?
* What is the pharmacokinectic profile of NS-079 in healthy participants under tested dosing regimen and the effect of paroxetine? Researchers will compare NS-079 to a placebo to see the safety and tolerability when use NS-079.

Conditions

  • Healthy Adult Participants

Interventions

DRUG

Placebo

NS-079 matching placebo

DRUG

NS-079 tablet

Investigational product NS-079

DRUG

Paroxetine

DDI study treatment drug

Sponsors & Collaborators

  • NeuShen Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-07-31
Completion
2027-05-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07669571 on ClinicalTrials.gov