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CompletedNCT06361212Updated Apr 11, 2024

Ethoximod Pharmacokinetics In Healthy Subjects

A Phase 1 interventional study of Ethoximod in Psoriasis, sponsored by Longevity Inc.. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Longevity Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Sep 2022, registered Mar 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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. to evaluate the safety and tolerance of Ethoximod in healthy subjects after single or repeated doses.
  2. to assess the pharmacokinetics and pharmacodynamics of Ethoximod in healthy subjects after single or repeated doses.
  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.
02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 65 is close to the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Longevity Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
  • 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).
  • Positive screening results for viral hepatitis (including hepatitis B and hepatitis C), HIV antibodies, and Treponema pallidum antibodies.
  • Acute illness or concomitant medication occurs from the screening stage to study medication.
  • Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking study drug.
  • Positive alcohol breath test 24 hours before taking study medication or upon check-in.
  • Those with a positive urine drug screen or a history of drug abuse within the past five years or 3 years before the test.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
65 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo Tablet

    Drug: Ethoximod

  • Experimental
    test drug

    Ethoximod Tablet, 5mg and 10mg

    Drug: Ethoximod

Interventions

  • DrugEthoximod

    Ethoximod is a S1P1 modulator.

06

What researchers measure

Primary outcomes

  1. Peak plasma concentration (Cmax)

    Time frame: Up to 64 days

  2. Time to peak plasma concentration (Tmax)

    Time frame: Up to 64 days

  3. The lowest plasma concentration (Cmin)

    Time frame: Up to 64 days

  4. Half-life (t1/2)

    Time frame: Up to 64 days

  5. Number of adverse events and number of participants with adverse events

    Time frame: Up to 64 days

Secondary outcomes

  1. Lymphocyte count

    Time frame: Up to 64 days

  2. Percentage of CD3+CD4+ and CD3+CD8+ T cells

    Time frame: Up to 64 days

07

Study locations

1 site
  • The first hospital of Jilin University
    Changchun, Jilin, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06361212
Lead sponsor
Longevity Inc.
Responsible party
Sponsor
First posted
Apr 11, 2024
Start date
Sep 1, 2022
Primary completion
Sep 20, 2022
Completion
Jan 12, 2024
Last update
Apr 11, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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