First-into-human Study of NS-136 in Healthy Subjects
Phase 1
Recruiting
- Conditions
- Healthy Subjects
- Interventions
- Drug: NS-136 tabletDrug: Placebo
- Registration Number
- NCT06345703
- Lead Sponsor
- NeuShen Therapeutics
- Brief Summary
The goal of this clinical trial is to exlplore the profile of NS-136 in health conditions. The main questions it aims to answer are:
* Is NS-136 safe and tolerable in heathy subjects under tested dosing regimen?
* What is the pharmacokinectic profile of NS-136 in healthy subjects under tested dosing regimen?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm6 NS-136 tablet Arm5 NS-136 MAD Dose 2 Arm7 NS-136 tablet FE Grp A Arm8 NS-136 tablet FE Grp B Arm14 Placebo NS-136 MAD Dose 2 PBO Arm5 NS-136 tablet Arm5 NS-136 MAD Dose 1 Arm11 Placebo NS-136 SAD Dose 3 PBO Arm12 Placebo NS-136 SAD Dose 4 PBO Arm2 NS-136 tablet NS-136 SAD Dose 2 Arm4 NS-136 tablet NS-136 SAD Dose 4 Arm9 Placebo NS-136 SAD Dose 1 PBO Arm10 Placebo NS-136 SAD Dose 2 PBO Arm13 Placebo NS-136 MAD Dose 1 PBO Arm1 NS-136 tablet NS-136 SAD Dose 1 Arm3 NS-136 tablet NS-136 SAD Dose 3
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment-Related Adverse Events for SAD, day 1-7; for MAD, day 1-26, for FE, day1-14 Main pharmacokinetic parameters for SAD, day 1-7; for MAD, day 1-26, Cmax
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Chengdu Xinhua Hospital
🇨🇳Chengdu, Sichuan, China
CMAX Clinical Research Pty Ltd
🇦🇺Adelaide, South Australia, Australia