Clinical trial · Interventional
Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers
A Dose Block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I Clinical Trial to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Male Volunteers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a Dose block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Escalation, Phase I clinical trial to assess the safety, tolerability and pharmacokinetics of single-dose and multiple-dose oral administration of the investigational product, EC-18 (study drug) in healthy adult male volunteers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Induced Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EC-18 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (16)
- type
- EXPERIMENTAL
- label
- Single dose group-Group 1-Experimental
- description
- Single dose, 500mg of Study drug(EC-18)
- interventionNames
- Drug: EC-18
- type
- PLACEBO_COMPARATOR
- label
- Single dose group-Group 1-Placebo
- description
- Single dose, 500mg of Placebo
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Single dose group-Group 2-Experimental
- description
- Single dose, 1000mg of Study drug(EC-18)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy adult male aged between 19 and 45 years, inclusive, at the time of providing the informed consent form * Body weight ≥ 50 kg, and calculated BMI in the range of 18.5 kg/m2 ≤ BMI \< 25.0 kg/m2 ☞ BMI(body mass index) = Body weight (kg)/\[height (m)\]2 * No inherited or chronic disease and pathologic symptoms or findings from internal examinations * Eligible subject based on findings from clinical laboratory tests, such as hematology, blood chemistry, urinalysis and immunoserology, and ECG, as conducted by a responsible doctor depending on characteristics of the drug * Written consent on voluntary decision of participation and compliance with precautions after being fully informed of and completely understanding this trial * Consent to practice medically acceptable contraception during the trial Exclusion Criteria: * Hypersensitivity to a drug containing an ingredient of the investigational product (EC-18) or similar ingredient (e.g., deer antler) or other drugs (e.g., aspirin, antibiotics) or medical history of clinically significant hypersensitivity * Active infection such as chronic or local infection based on screening tests or inquiry, verifiable medical records * Serious infection that required hospitalization or use of antibiotics within 30 days prior to the first dose of the investigational product, based on an inquiry or verifiable medical records * Presence of a clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous, blood, cardiovascular, urogenital, psychiatric disorder or its prior history * (1) Presenting tuberculosis or prior history of tuberculosis or (2) positive results from a QuantiFERON® -TB Gold in Tube Assay conducted due to a contact with a tuberculosis patient within the past 3 months or signs and symptoms of suspected tuberculosis * Prior history of a gastrointestinal disorder (e.g., Crohn's disease, ulcer) or surgery (except for simple appendectomy or hernia surgery) that may affect drug absorption, etc.
References
Publications (0)
Data not yet available