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A Safety, Tolerability, and Pharmacokinetic Study of NIP292 in Healthy Normal Subjects

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female (non-childbearing potential) subjects between age 18 and 55 years (inclusive), in general good health without clinically significant abnormalities. 2. Female subjects of non-childbearing potential will be authorized to participate in this study if at least one of the following criteria are met: 1. Surgical sterilization (e.g., hysterectomy, bilateral oophorectomy and/or bilateral salpingectomy, but excluding bilateral tubal occlusion); 2. 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. 3. Body mass index (BMI) of 18-32 kg/m2 (inclusive), and a total body weight >50 kg (110 lb). 4. 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. 5. Subjects who are willing and able to comply with the prescribed protocol treatment and evaluations. 6. Subjects must provide signed written informed consent prior to any study-specific procedures.

Exclusion Criteria:

Subjects with any of the following characteristics or conditions will not be included in the study: 1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies). 2. History of drug abuse in the past 5 years, or a positive urine drug test at screening or the admission. 3. 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. 4. Current smoker, or difficulty abstaining from smoking for the duration of study confinement. 5. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. 6. 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. 7. Previous participation in this study; subjects can only be randomized and receive the study medication in 1 of the 2 parts in this study. 8. Any condition possibly affecting drug absorption per the principal investigator's discretion (e.g., gastrectomy). 9. 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. 10. 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. 11. 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). 12. 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. 13. Blood donation (excluding plasma donations) of approximately 450 mL or more within 60 days prior to the first dose of study medication. 14. History of sensitivity to heparin or heparin induced thrombocytopenia (if heparin is used to flush intravenous catheters used during serial blood collections). 15. Unwilling or unable to comply with this study protocol. 16. 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04720443
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The National Institutes of Pharmaceutical R&D Co. Ltd, China
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions

Arms

Experimental: SAD Part 1 Cohort 1

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.

Experimental: SAD Part 1 Cohort 2

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.

Experimental: SAD Part 1 Cohort 3

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.

Experimental: SAD Part 1 Cohort 4

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.

Experimental: SAD Part 1 Cohort 5

Eight subjects will be randomized at a ratio of 3:1 in each cohort to receive either NIP292 (oral tablet at 600 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.

Experimental: SAD Part 1 Cohort 6

Eight subjects will be randomized at a ratio of 3:1 in each cohort to receive either NIP292 (oral tablet at 900 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.

Experimental: MAD Part 2 Cohort 1

Eight subjects will be randomized at a ratio of 3:1 in each cohort to receive either NIP292 (oral tablet dosage TBD) 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). Three dose levels (low dose, medium dose, and high dose) proposed for MAD part will be determined based on the doses evaluated in SAD part (including a dose higher than 900 mg if it is indicated).

Experimental: MAD Part 2 Cohort 2

Eight subjects will be randomized at a ratio of 3:1 in each cohort to receive either NIP292 (oral tablet dosage TBD) 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). Three dose levels (low dose, medium dose, and high dose) proposed for MAD part will be determined based on the doses evaluated in SAD part (including a dose higher than 900 mg if it is indicated).

Experimental: MAD Part 2 Cohort 3

Eight subjects will be randomized at a ratio of 3:1 in each cohort to receive either NIP292 (oral tablet dosage TBD) 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). Three dose levels (low dose, medium dose, and high dose) proposed for MAD part will be determined based on the doses evaluated in SAD part (including a dose higher than 900 mg if it is indicated).

Interventions

Drug: - NIP292 tablet

NIP292 (oral tablet at 10 mg) or placebo

Drug: - NIP292 tablet

NIP292 (oral tablet at 30 mg) or placebo

Drug: - NIP292 tablet

NIP292 (oral tablet at 100 mg) or placebo

Drug: - NIP292 tablet

NIP292 (oral tablet at 300 mg) or placebo

Drug: - NIP292 tablet

NIP292 (oral tablet at 600 mg) or placebo

Drug: - NIP292 tablet

NIP292 (oral tablet at 900 mg) or placebo

Drug: - NIP292 tablets

NIP292 (oral tablet at dosage TBD) or placebo

Drug: - NIP292 tablets

NIP292 (oral tablet at dosage TBD) or placebo

Drug: - NIP292 tablets

NIP292 (oral tablet at dosage TBD) or placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

PAREXEL International, Glendale, California

Status

Recruiting

Address

PAREXEL International

Glendale, California, 91206

Site Contact

Amy Kazaryan

Amy.Kazaryan@parexel.com

818-254-1999