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NIP292 tablets for Idiopathic Pulmonary Fibrosis

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 37 days for reporting.

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 more

Secondary 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 more

Awards & 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