A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Proximod in Healthy Subjects.

Longevity Inc.1 site in 1 country134 target enrollmentSeptember 14, 2017

ConditionsRheumatoid Arthritis

InterventionsPlacebo Proximod

DrugsProximod Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Rheumatoid Arthritis
Sponsor: Longevity Inc.
Enrollment: 134
Locations: 1
Primary Endpoint: Peak plasma concentration (Cmax)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects. The main questions it arms to answer are:

to evaluate the safety and tolerance of Proximod in healthy subjects after single or repeated doses.
to learn the pharmacodynamics of Proximod in healthy subjects after single or repeated doses.
to evaluation of the effect of food on the pharmacokinetics of Proximod in healthy subjects Participants will receive test tablets or placebo at the indicated date and collect blood samples.

Registry

clinicaltrials.gov

Start Date

September 14, 2017

End Date

June 22, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Longevity Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Before the test, sign an informed consent form and fully understand the written test content, process and possible adverse reactions.
•Complete research in accordance with the requirements of the trial plan.
•Subjects (including partners) are willing to have no pregnancy plans in the next 6 months and voluntarily take effective contraceptive measures.
•Male and female subjects aged 18 to 50 years old (including 18 and 50 years old).
•Male subjects must weigh no less than 50 kg, and female subjects must weigh no less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), body mass index is in the range of 18\~28kg/m2 (including the critical value).
•Health status: No clinically significant history of heart, liver, kidney, digestive tract, nervous system, respiratory system (such as asthma, exercise-induced asthma, chronic obstructive pulmonary disease), mental disorder, metabolic abnormality, etc.
•Normal physical examination and vital signs or abnormal without clinical significance.

Exclusion Criteria

•Those who smoked more than 5 cigarettes per day in the 3 months before the test.
•Have a history of allergy to the trial drug or its excipients, or allergic constitution (allergy to multiple drugs and food).
•Have a history of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine).
•Blood donation or significant blood loss (\>450 mL) within three months before screening.
•Taking any drugs that alter liver enzyme activity 28 days before screening.
•Take any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines within 14 days before screening.
•Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or engaged in strenuous exercise within 2 weeks before screening, or other factors that affect drug absorption, distribution, metabolism, excretion, etc.
•Concomitant inhibitors or inducers of CYP3A4, P-gp or Bcrp such as itraconazole, ketoconazole or dronedarone.
•Recent significant changes in eating or exercise habits.
•Participated in a drug clinical trial within three months before taking the study drug.