Idiopathic Pulmonary FibrosisPhase 1NCT04720443
A Safety, Tolerability, and Pharmacokinetic Study of NIP292 in Healthy Normal Subjects
A Phase 1 study testing NIP292 tablet and NIP292 tablets in people with Idiopathic Pulmonary Fibrosis, run by The National Institutes of Pharmaceutical R&D Co. Ltd, China at 1 site in United States.
Trial summary
This study is being conducted to evaluate the safety and tolerability of single ascending and multiple ascending oral doses of NIP292 tablets administered following an overnight fast in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- NIP292 tablet and NIP292 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2019to 14 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female (non-childbearing potential) subjects between age 18 and 55 years (inclusive), in general good health without clinically significant abnormalities.
- Female subjects of non-childbearing potential will be authorized to participate in this study if at least one of the following criteria are met:
- Surgical sterilization (e.g., hysterectomy, bilateral oophorectomy and/or bilateral salpingectomy, but excluding bilateral tubal occlusion);
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state (with a single repeat permitted if deemed necessary by the investigator); and β-human chorionic gonadotropin (β-HCG) is negative at screening and the admission.
- Body mass index (BMI) of 18-32 kg/m2 (inclusive), and a total body weight >50 kg (110 lb).
- Clinical laboratory values within the normal limits as defined by the clinical laboratory. Of note, individual values out of normal range can be accepted if judged as not clinically significant by the investigator. Repeat assessment can be conducted at the discretion of the investigator or delegate.
- Subjects who are willing and able to comply with the prescribed protocol treatment and evaluations.
- Subjects must provide signed written informed consent prior to any study-specific procedures.
Who cannot join
- Subjects with any of the following characteristics or conditions will not be included in the study:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
- History of drug abuse in the past 5 years, or a positive urine drug test at screening or the admission.
- History of excessive alcohol intake exceeding 14 drinks/week (1 drink = 5 ounces [150 mL] of wine, or 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard liquor) within 6 months of screening, or a positive alcohol breath test at screening or the admission.
- Current smoker, or difficulty abstaining from smoking for the duration of study confinement.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
Show all 17Show fewer
- Use of prescription or nonprescription drugs or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication; however, limited use of nonprescription medications that are not believed to affect the overall results of the study may be permitted on a case by case basis following approval by the investigator and the Sponsor.
- Previous participation in this study; subjects can only be randomized and receive the study medication in 1 of the 2 parts in this study.
- Any condition possibly affecting drug absorption per the principal investigator's discretion (e.g., gastrectomy).
- Screening supine systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg. If SBP ≥140 mmHg or DBP ≥90 mmHg, the blood pressure assessment should be repeated 2 more times and the average of the 3 blood pressure values should be used to determine the subject's eligibility.
- Screening supine 12-lead ECG demonstrating a QTcF (using Fridericia's formula, QTcF = QT/RR1/3) interval >450 msec for males or >470 msec for females,or a QRS interval >120 msec. If QTcF >450 msec or QRS >120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the subject's eligibility.
- Subjects with history of hepatitis, or positive result at screening for hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), hepatitis C antibody (HCVAb), or human immunodeficiency virus antibody (HIVAb).
- Pregnant female subjects; breastfeeding female subjects; male subjects able to father children who are unable to use a highly effective method of contraception for the duration of the study and for at least 90 days after the last dose of study medication.
- Blood donation (excluding plasma donations) of approximately 450 mL or more within 60 days prior to the first dose of study medication.
- History of sensitivity to heparin or heparin induced thrombocytopenia (if heparin is used to flush intravenous catheters used during serial blood collections).
- Unwilling or unable to comply with this study protocol.
- Any other medical or psychiatric condition that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Two-Part Study of NIP292 Tablets in Healthy Adult Subjects: Part 1 - Randomized, Double-Blind, Placebo-Controlled Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses; Part 2 - Randomized, Double-Blind, Placebo-Controlled Assessment of Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses.
This study is being conducted to evaluate the safety and tolerability of single ascending and multiple ascending oral doses of NIP292 tablets administered following an overnight fast in healthy adult subjects.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- NIP292 tablet, NIP292 tablets
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIP292 tabletDrug
NIP292 (oral tablet at 10 mg) or placebo
NIP292 tabletDrug
NIP292 (oral tablet at 30 mg) or placebo
NIP292 tabletDrug
NIP292 (oral tablet at 100 mg) or placebo
NIP292 tabletDrug
NIP292 (oral tablet at 300 mg) or placebo
NIP292 tabletDrug
NIP292 (oral tablet at 500 mg) or placebo
NIP292 tabletsDrug
NIP292 (oral tablet at dosage 1) or placebo
NIP292 tabletsDrug
NIP292 (oral tablet at dosage 2) or placebo
| Study group | Role | What they receive |
|---|---|---|
| SAD Part 1 Cohort 1 | Experimental | 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. Receives: Drug: NIP292 tablet |
| SAD Part 1 Cohort 2 | Experimental | 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. Receives: Drug: NIP292 tablet |
| SAD Part 1 Cohort 3 | Experimental | 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. Receives: Drug: NIP292 tablet |
| SAD Part 1 Cohort 4 | Experimental | 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. Receives: Drug: NIP292 tablet |
| SAD Part 1 Cohort 5 | Experimental | 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. Receives: Drug: NIP292 tablet |
| MAD Part 2 Cohort 1 | Experimental | 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. Receives: Drug: NIP292 tablets |
| MAD Part 2 Cohort 2 | Experimental | 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. Receives: Drug: NIP292 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence, potential significance, and clinical importance of adverse events (AE) after single dose of NIP292 in 48 healthy subject.
The AEs developed during or after the study treatment (as treatment-emergent adverse event [TEAE]) will be summarized by preferred term, system organ class, severity, and relationship to the investigational product.
Measured: 31 days
To evaluate the incidence, potential significance, and clinical importance of adverse events (AE) after multipe dose of NIP292 in 24 healthy subject.
The AEs developed during or after the study treatment (as treatment-emergent adverse event [TEAE]) will be summarized by preferred term, system organ class, severity, and relationship to the investigational product.
Measured: 37 days
The change of Clinical Laboratory Tests
Descriptive statistics of absolute values and changes from baseline will be summarized by dose/regimen and time. Laboratory abnormalities will be tabulated by time.
Measured: 31 days in SAD
The change of Clinical Laboratory Tests
Descriptive statistics of absolute values and changes from baseline will be summarized by dose/regimen and time. Laboratory abnormalities will be tabulated by time.
Measured: 37 days in MAD
Electrocardiogram (ECG)
Changes from baseline for the ECG parameters (i.e., QT, heart rate, QTcF, PR and QRS) will be summarized by dose/regimen and time. The number (%) of subjects with maximum post-dose QTcF values and maximum increases from baseline will be tabulated by regimen.
Measured: 31 days in SAD
Electrocardiogram (ECG)
Changes from baseline for the ECG parameters (i.e., QT, heart rate, QTcF, PR and QRS) will be summarized by dose/regimen and time. The number (%) of subjects with maximum post-dose QTcF values and maximum increases from baseline will be tabulated by regimen.
Measured: 37 days in MAD
Secondary outcomes (7)
To characterize the maximum plasma concentration(Cmax) of NIP292 tablets in 48 healthy adult subjects.
PK parameters derived from plasma NIP292 concentration data following single oral doses: maximum plasma concentration(Cmax)
Measured: 31 days
To characterize the time to maximum plasma concentration (Tmax) of NIP292 tablets in 48 healthy adult subjects.
PK parameters derived from plasma NIP292 concentration data following single oral doses: time to maximum plasma concentration (Tmax)
Measured: 31 days
To characterize the time to area under the concentration-time curve from hour 0 to last postdose(AUC0-last) of NIP292 tablets in 48 healthy adult subjects.
PK parameters derived from plasma NIP292 concentration data following single oral doses: area under the concentration-time curve from hour 0 to last postdose(AUC0-last)
Measured: 31 days
To characterize the maximum plasma concentration(Cmax) of NIP292 tablets in 24 healthy adult subjects.
PK parameters derived from plasma NIP292 concentration data following multiple oral doses: maximum plasma concentration (Cmax)
Measured: 37 days
To characterize the time to maximum plasma concentration (Tmax) of NIP292 tablets in 24 healthy adult subjects.
PK parameters derived from plasma NIP292 concentration data following multiple oral doses: time to maximum plasma concentration (Tmax)
Measured: 37 days
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.
PK parameters derived from plasma NIP292 concentration data following multiple oral doses:area under the concentration-time curve from hour 0 to last postdose(AUC0-last)
Measured: 37 days
To characterize the renal clearance of NIP292 tablets, if data permit
the urine PK parameters:renal clearance(CLr)
Measured: 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start22 Nov 2019
- Primary completion14 Jul 2022
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Institutes of Pharmaceutical R&D Co. Ltd, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720443
- Sponsor's protocol ID
- NIP292-101
- Status last verified
- Mar 2023
- First submitted
- 30 Dec 2020
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-Part Study of NIP292 Tablets in Healthy Adult Subjects: Part 1 - Randomized, Double-Blind, Placebo-Controlled Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses; Part 2 - Randomized, Double-Blind, Placebo-Controlled Assessment of Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses.
- ClinicalTrials.gov ID
- NCT04720443
- Acronym / sponsor ID
- NIP292-101
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The National Institutes of Pharmaceutical R&D Co. Ltd, ChinaIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the safety and tolerability of single ascending and multiple ascending oral doses of NIP292 tablets administered following an overnight fast in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SAD Part 1 Cohort 1 | Experimental | Drug: NIP292 tabletEight 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. |
| SAD Part 1 Cohort 2 | Experimental | Drug: NIP292 tabletEight 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. |
| SAD Part 1 Cohort 3 | Experimental | Drug: NIP292 tabletEight 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. |
| SAD Part 1 Cohort 4 | Experimental | Drug: NIP292 tabletEight 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. |
| SAD Part 1 Cohort 5 | Experimental | Drug: NIP292 tabletEight 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. |
| MAD Part 2 Cohort 1 | Experimental | Drug: NIP292 tabletsEight 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. |
| MAD Part 2 Cohort 2 | Experimental | Drug: NIP292 tabletsEight 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female (non-childbearing potential) subjects between age 18 and 55 years (inclusive), in general good health without clinically significant abnormalities.
- Female subjects of non-childbearing potential will be authorized to participate in this study if at least one of the following criteria are met:
- Body mass index (BMI) of 18-32 kg/m2 (inclusive), and a total body weight >50 kg (110 lb).
- Clinical laboratory values within the normal limits as defined by the clinical laboratory. Of note, individual values out of normal range can be accepted if judged as not clinically significant by the investigator. Repeat assessment can be conducted at the discretion of the investigator or delegate.
- Subjects who are willing and able to comply with the prescribed protocol treatment and evaluations.
Key exclusion criteria (17 listed)
- Subjects with any of the following characteristics or conditions will not be included in the study:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
- History of drug abuse in the past 5 years, or a positive urine drug test at screening or the admission.
- History of excessive alcohol intake exceeding 14 drinks/week (1 drink = 5 ounces [150 mL] of wine, or 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard liquor) within 6 months of screening, or a positive alcohol breath test at screening or the admission.
- Current smoker, or difficulty abstaining from smoking for the duration of study confinement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIP292 tabletNIP292 (oral tablet at 10 mg) or placebo | Drug | SAD Part 1 Cohort 1 |
| NIP292 tabletNIP292 (oral tablet at 30 mg) or placebo | Drug | SAD Part 1 Cohort 2 |
| NIP292 tabletNIP292 (oral tablet at 100 mg) or placebo | Drug | SAD Part 1 Cohort 3 |
| NIP292 tabletNIP292 (oral tablet at 300 mg) or placebo | Drug | SAD Part 1 Cohort 4 |
| NIP292 tabletNIP292 (oral tablet at 500 mg) or placebo | Drug | SAD Part 1 Cohort 5 |
| NIP292 tabletsNIP292 (oral tablet at dosage 1) or placebo | Drug | MAD Part 2 Cohort 1 |
| NIP292 tabletsNIP292 (oral tablet at dosage 2) or placebo | Drug | MAD Part 2 Cohort 2 |
Primary outcome
To evaluate the incidence, potential significance, and clinical importance of adverse events (AE) after single dose of NIP292 in 48 healthy subject.
Time frame: 31 days
The AEs developed during or after the study treatment (as treatment-emergent adverse event [TEAE]) will be summarized by preferred term, system organ class, severity, and relationship to the investigational product.
To evaluate the incidence, potential significance, and clinical importance of adverse events (AE) after multipe dose of NIP292 in 24 healthy subject.
Time frame: 37 days
The AEs developed during or after the study treatment (as treatment-emergent adverse event [TEAE]) will be summarized by preferred term, system organ class, severity, and relationship to the investigational product.
The change of Clinical Laboratory Tests
Time frame: 31 days in SAD
Descriptive statistics of absolute values and changes from baseline will be summarized by dose/regimen and time. Laboratory abnormalities will be tabulated by time.
The change of Clinical Laboratory Tests
Time frame: 37 days in MAD
Descriptive statistics of absolute values and changes from baseline will be summarized by dose/regimen and time. Laboratory abnormalities will be tabulated by time.
Electrocardiogram (ECG)
Time frame: 31 days in SAD
Changes from baseline for the ECG parameters (i.e., QT, heart rate, QTcF, PR and QRS) will be summarized by dose/regimen and time. The number (%) of subjects with maximum post-dose QTcF values and maximum increases from baseline will be tabulated by regimen.
Electrocardiogram (ECG)
Time frame: 37 days in MAD
Changes from baseline for the ECG parameters (i.e., QT, heart rate, QTcF, PR and QRS) will be summarized by dose/regimen and time. The number (%) of subjects with maximum post-dose QTcF values and maximum increases from baseline will be tabulated by regimen.
7 secondary outcomes
To characterize the maximum plasma concentration(Cmax) of NIP292 tablets in 48 healthy adult subjects.
Time frame: 31 days
To characterize the time to maximum plasma concentration (Tmax) of NIP292 tablets in 48 healthy adult subjects.
Time frame: 31 days
To characterize the time to area under the concentration-time curve from hour 0 to last postdose(AUC0-last) of NIP292 tablets in 48 healthy adult subjects.
Time frame: 31 days
To characterize the maximum plasma concentration(Cmax) of NIP292 tablets in 24 healthy adult subjects.
Time frame: 37 days
To characterize the time to maximum plasma concentration (Tmax) of NIP292 tablets in 24 healthy adult subjects.
Time frame: 37 days
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.
Time frame: 37 days
To characterize the renal clearance of NIP292 tablets, if data permit
Time frame: 37 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NIP292 tablet and NIP292 tablets in people with Idiopathic Pulmonary Fibrosis, run by The National Institutes of Pharmaceutical R&D Co. Ltd, China at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the incidence, potential significance, and clinical importance of adverse events (AE) after single dose of NIP292 in 48 healthy subject. (time frame: 31 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.