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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

Study Summary

This trial is to see if NIP292 tablets are safe and tolerated when taken by healthy adults.

Eligible Conditions
  • Idiopathic Pulmonary Fibrosis

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can adults aged 70 and above partake in this clinical trial?

"The stated parameters for enrolment in this trial require that patients must be at least 18 years old and no older than 55."

Answered by AI

Is there any availability to join the current clinical experiment?

"Affirmative. Clinicaltrials.gov indicates that this trial was published on November 22nd 2019, and is currently looking for 72 participants from a single site to partake in the study. The listing has been last modified April 5th 2022."

Answered by AI

To whom is access to this research program available?

"This clinical trial is enrolling 72 participants with usual interstitial pneumonia aged 18 to 55. Candidates should generally be in good health, have laboratory values within normal limits as defined by the lab, achieved postmenopausal status (with a single repeat assessment if deemed necessary), BMI of 18-32 kg/m2 and total body weight over 50kg, willing and able to comply with prescribed protocol treatment and evaluations, and provide signed written informed consent prior to any study-specific procedures."

Answered by AI

Has NIP292 tablets received the green light from the FDA?

"As this is an experimental, first-phase trial, the safety of NIP292 tablets was assumed to be at a level 1. This means there are limited data supporting both efficacy and safety."

Answered by AI

What beneficial results are being targeted by this research?

"As per The National Institutes of Pharmaceutical R&D Co. Ltd., China, the primary aim gauged over a month-long period is to review and assess any unfavourable outcomes that may arise after single dose administration of NIP292 in 48 healthy individuals. Other objectives include characterizing Tmax, CLr and AUC0-last as derived from plasma concentration data following multiple dosages."

Answered by AI

How many participants have enrolled in the experiment?

"Affirmative. According to the information posted on clinicaltrials.gov, this medical trial launched in November of 2019 and is still actively sourcing participants; 72 patients are required for a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Safety, Tolerability, and Pharmacokinetic Study of NIP292 in Healthy Normal Subjects
2019. "A Safety, Tolerability, and Pharmacokinetic Study of NIP292 in Healthy Normal Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04720443.
~10 spots leftby Apr 2025
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