Your session is about to expire
← Back to Search
Unknown
A Safety, Tolerability, and Pharmacokinetic Study of NIP292 in Healthy Normal Subjects
Phase 1
Waitlist Available
Research Sponsored by The National Institutes of Pharmaceutical R&D Co. Ltd, China
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 37 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety of NIP292 tablets taken by mouth in increasing doses in healthy adults.
Eligible Conditions
- Idiopathic Pulmonary Fibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 37 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~37 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Electrocardiogram (ECG)
The change of Clinical Laboratory Tests
To evaluate the incidence, potential significance, and clinical importance of adverse events (AE) after multipe dose of NIP292 in 24 healthy subject.
+1 moreSecondary study objectives
To characterize the area under the concentration-time curve from hour 0 to last postdose(AUC0-last) of NIP292 tablets in 24 healthy adult subjects.
To characterize the maximum plasma concentration(Cmax) of NIP292 tablets in 24 healthy adult subjects.
To characterize the maximum plasma concentration(Cmax) of NIP292 tablets in 48 healthy adult subjects.
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Group I: SAD Part 1 Cohort 5Experimental Treatment1 Intervention
Eight subjects will be randomized at a ratio of 3:1 in each cohort to receive either NIP292 (oral tablet at 500 mg)or placebo. In each cohort, to mitigate any unforeseen safety issues, the first 2 subjects (1 active + 1 placebo) will be admitted and dosed, and at least 48 hours apart from the other 6 subjects. The remaining 6 subjects of each cohort will be dosed after review of the safety data of the first 2 subjects.
Group II: SAD Part 1 Cohort 4Experimental Treatment1 Intervention
Eight subjects will be randomized at a ratio of 3:1 in each cohort to receive either NIP292 (oral tablet at 300 mg) or placebo. In each cohort, to mitigate any unforeseen safety issues, the first 2 subjects (1 active + 1 placebo) will be admitted and dosed, and at least 48 hours apart from the other 6 subjects. The remaining 6 subjects of each cohort will be dosed after review of the safety data of the first 2 subjects.
Group III: SAD Part 1 Cohort 3Experimental Treatment1 Intervention
Eight subjects will be randomized at a ratio of 3:1 in each cohort to receive either NIP292 (oral tablet at 100mg) or placebo. In each cohort, to mitigate any unforeseen safety issues, the first 2 subjects (1 active + 1 placebo) will be admitted and dosed, and at least 48 hours apart from the other 6 subjects. The remaining 6 subjects of each cohort will be dosed after review of the safety data of the first 2 subjects.
Group IV: SAD Part 1 Cohort 2Experimental Treatment1 Intervention
Eight subjects will be randomized at a ratio of 3:1 in each cohort to receive either NIP292 (oral tablet at 30 mg) or placebo. In each cohort, to mitigate any unforeseen safety issues, the first 2 subjects (1 active + 1 placebo) will be admitted and dosed, and at least 48 hours apart from the other 6 subjects. The remaining 6 subjects of each cohort will be dosed after review of the safety data of the first 2 subjects.
Group V: SAD Part 1 Cohort 1Experimental Treatment1 Intervention
Eight subjects will be randomized at a ratio of 3:1 in each cohort to receive either NIP292 (oral tablet at 10 mg) or placebo. In each cohort, to mitigate any unforeseen safety issues, the first 2 subjects (1 active + 1 placebo) will be admitted and dosed, and at least 48 hours apart from the other 6 subjects. The remaining 6 subjects of each cohort will be dosed after review of the safety data of the first 2 subjects.
Group VI: MAD Part 2 Cohort 2Experimental Treatment1 Intervention
Eight subjects will be randomized at a ratio of 3:1 in each cohort to receive either NIP292 (oral tablet dosage 2) or placebo. All subjects will receive either NIP292 or placebo on an empty stomach for 7 days (from Day 1 to Day 7), and dosing frequency will be identical and either QD, Q12H, or Q8H (depending on the observed PK data in Part 1). Two dose levels (dose 1 and dose 2) proposed for MAD part will be determined based on the doses evaluated in SAD part.
Group VII: MAD Part 2 Cohort 1Experimental Treatment1 Intervention
Eight subjects will be randomized at a ratio of 3:1 in each cohort to receive either NIP292 (oral tablet dosage 1) or placebo. All subjects will receive either NIP292 or placebo on an empty stomach for 7 days (from Day 1 to Day 7), and dosing frequency will be identical and either QD, Q12H, or Q8H (depending on the observed PK data in Part 1). Two dose levels (dose 1 and dose 2) proposed for MAD part will be determined based on the doses evaluated in SAD part.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NIP292 tablet
2019
Completed Phase 1
~60
NIP292 tablets
2019
Completed Phase 1
~60
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
The National Institutes of Pharmaceutical R&D Co. Ltd, ChinaLead Sponsor