A Phase I Study of NS-079 in Healthy Participants
ConditionHealthy Adult Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNeuShen Therapeutics
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy males or females aged 18-55 years (inclusive), with a body mass index (BMI) between 18.00 and 32.00 kg/m2(inclusive) at screening.
Not participated in any other clinical trials and received an investigational drug or device within the past 30 days or 5 half-lives prior to screening, whichever is longer.
Women of non-childbearing potential (WONCBP) (as defined in Appendix 1); women of childbearing potential (WOCBP) who are abstinent from heterosexual intercourse as a preferred and usual lifestyle choice, or who agree to use highly effective contraception (as defined in Appendix 1) in combination with a condom from the time of signing the informed consent form until at least 90 days after the last dose of investigational product, agree to refrain from ova donation during this period, and return a negative pregnancy test at screening and baseline (Day -1).
Surgically sterile males (with verbal confirmation of the absence of sperm in the ejaculate); males who are abstinent from heterosexual intercourse as a preferred and usual lifestyle choice, or who agree to use highly effective contraception with a female partner (as defined in Appendix 1) in combination with a condom from the time of signing the informed consent form until at least 90 days after the last dose of investigational product, and agree to refrain from sperm donation during this period.
Disqualifiers
Known hypersensitivity or allergy to the investigational product, its excipients, or any of its components, or a history of clinically significant allergic reactions that, in the opinion of the investigator/delegate, may place the participant at increased risk.
Known hypersensitivity to or severe intolerance of paroxetine or any SSRI (including serotonin syndrome or discontinuation syndrome) (for Part 3 [DDI] only).
Unable to refrain from all known CYP2D6 substrate medications (including over-the-counter (OTC) medications such as dextromethorphan-containing cough and cold preparations) during paroxetine dosing (for Part 3 [DDI] only). Final clinical judgment on individual concomitant medications remains with the investigator/delegate.
Individuals with a history of intolerance to venipuncture or venous catheterization (e.g., recurrent syncope during blood draws or significant needle phobia) that, in the opinion of the investigator/delegate, may interfere with the study procedures.
Trial design
Design model
Sequential
Treatments tested in this trial
Placebo
DrugNS-079 matching placebo
NS-079 tablet
DrugInvestigational product NS-079
Paroxetine
DrugDDI study treatment drug
Treatment groups
78 Participants
are divided into 17 treatment groups17
Treatment groupsSee each treatment group below.
Group A: NS-079 Arm 1Experimental treatment 1 intervention
Group B: NS-079 Arm 2Experimental treatment 1 intervention
Group C: NS-079 Arm 3Experimental treatment 1 intervention
Group D: NS-079 Arm 4Experimental treatment 1 intervention
Group E: NS-079 Arm 5Experimental treatment 1 intervention
Group F: NS-079 Arm 6Experimental treatment 1 intervention
Group G: NS-079 Arm 7Experimental treatment 1 intervention
Group H: NS-079 Arm 8Experimental treatment 1 intervention
Group I: Placebo Arm 9Placebo comparator 1 intervention
Group J: Placebo Arm 10Placebo comparator 1 intervention
Group K: Placebo Arm 11Placebo comparator 1 intervention
Group L: Placebo Arm 12Placebo comparator 1 intervention
Group M: Placebo Arm 13Placebo comparator 1 intervention
Group N: Placebo Arm 14Placebo comparator 1 intervention
Group O: Placebo Arm 15Placebo comparator 1 intervention
Group P: Placebo Arm 16Placebo comparator 1 intervention
Group Q: NS-079 Arm 17Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants with Treatment-Related Adverse Events
Time frame
for SAD, day 1-4; for MAD, day 1-14, for DDI, day1-302
Main pharmacokinetic parameters
Cmax
Time frame
for SAD, day 1-4; for MAD, day 1-14, for DDI, day1-303
Main pharmacokinetic parameters
Cmax,ss
Time frame
for MAD, day 1-144
Main pharmacokinetic parameters
NS-079-M1/NS-079 AUC ratio as an in vivo CYP2D6 fm biomarker
Time frame
For DDI, Day 1- 30Sponsors and contacts
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Source ClinicalTrials.gov