Ethoximod Pharmacokinetics In Healthy Subjects

NCT06361212 | Completed Phase 1

• 1 other identifier: BJXH-2022-002
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (5)

• Peak plasma concentration (Cmax)

  Up to 64 days

• Time to peak plasma concentration (Tmax)

  Up to 64 days

• The lowest plasma concentration (Cmin)

  Up to 64 days

• Half-life (t1/2)

  Up to 64 days

• Number of adverse events and number of participants with adverse events

  Up to 64 days

Secondary Outcomes (2)

• Lymphocyte count

  Up to 64 days

• Percentage of CD3+CD4+ and CD3+CD8+ T cells

  Up to 64 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo Tablet

Drug: Ethoximod

test drug

EXPERIMENTAL

Ethoximod Tablet, 5mg and 10mg

Drug: Ethoximod

Interventions

Ethoximod DRUG

Ethoximod is a S1P1 modulator.

Placebo; test drug

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Recent significant changes in eating or exercise habits.
• Participated in a drug clinical trial within three months before taking the study drug.
• Have a history of dysphagia or any gastrointestinal disease that affects drug absorption.
• Suffering from any disease that increases the risk of bleeding, such as acute gastritis or gastric and duodenal ulcers.
• ECG abnormalities have clinical significance or QTC\>470ms in men or QTC\>480ms in women.
• Those with a history of herpes zoster or chickenpox.
• Female subjects are lactating or have positive serum pregnancy results during the screening period or during the trial.
• Clinically significant abnormalities in clinical laboratory tests or other clinically significant following diseases diagnosed within 12 months (including but not limited to gastrointestinal, renal, liver, neurological, blood, endocrine, tumor, lung, immune, psychiatric or Cardiovascular disease).

Sponsors & Collaborators

• Longevity Inc.: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 11, 2024
• Study Start: September 1, 2022
• Primary Completion: September 20, 2022
• Study Completion: January 12, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)