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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    72
  • sponsor
    The National Institutes of Pharmaceutical R&D Co. Ltd, China
Updated on 21 April 2022
body mass index
hysterectomy
follicle stimulating hormone
at 10
Accepts healthy volunteers

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.

Details
Condition Idiopathic Pulmonary Fibrosis
Treatment NIP292 tablet, NIP292 tablets
Clinical Study IdentifierNCT04720443
SponsorThe National Institutes of Pharmaceutical R&D Co. Ltd, China
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Unwilling or unable to comply with this study protocol
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)
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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