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

NCT04720443 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-03-24

No results posted yet for this study

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.

Conditions

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 500 mg) or placebo

DRUG

NIP292 tablets

NIP292 (oral tablet at dosage 1) or placebo

DRUG

NIP292 tablets

NIP292 (oral tablet at dosage 2) or placebo

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2022-07-14
Completion
2022-07-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04720443 on ClinicalTrials.gov