Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT06570668
Eligibility Criteria:
Inclusion Criteria:
* An individual must meet all the criteria below to be eligible for participation in this study:
1. Male or female
2. Aged 18-65 years (inclusive)
3. Body weight of 50kg or more
4. BMI 18.5-29.9 kg/m2 (inclusive)
5. Normal hepatic: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma glutamyl transferase (GGT) and total bilirubin not elevated more than 1.2-fold above the upper limit of normal (ULN)
6. Normal renal function: glomerular filtration rate (GFR) ≥ 90 mL/min/1.7m2
7. Understand the study procedures and agree to participate by providing written informed consent
8. Be willing and able to comply with all study procedures and restrictions
9. Be a nonsmoker who has not used tobacco- or nicotine-containing products (e.g., nicotine patch) for at least 6 months before administration of the investigational drug
10. Be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign assessment performed at the Screening Visit and before administration of the investigational drug
11. Contraceptive use by men or women should be consistent with local regulations regarding the methods of conception for those participating in clinical study
Exclusion Criteria:
* An individual who meets any of the following criteria will be excluded:
1. Pregnant, trying to become pregnant or lactating
2. Use of any prescription, non-prescription drug and investigational drug within 30 days prior to administration of the study drug
3. Has a substance abuse disorder
4. Has a history of clinically significant endocrine, gastrointestinal (including motility disorder and intestinal obstruction), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
5. Has a history of cancer (malignancy)
6. Has a known hypersensitivity to any component of the formulation of CDD-2101, its related compounds or placebo, or allergy to Chinese herbal medicine
7. Has a history of significant multiple and/or severe allergies (e.g., food, drug or latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
8. Had major surgery, donated, or lost 1 unit of blood (approximately 500 mL) within 8 weeks before administration of the investigational drug
9. Diagnosis of bowel disorders based on the Rome IV criteria
10. Has a history of positive for hepatitis B, hepatitis C or HIV
11. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink is approximately equivalent to: beer (354 mL/12 ounces), wine (118 mL/4 ounces), or distilled spirits (29.5 mL/1 ounce)
12. Has participated in another investigational trial within 4 weeks before the pretrial (Screening) visit. The 4-week window will be derived from the date of the last trial procedure and/or AE related to the trial procedure in the previous trial to the pretrial/Screening Visit of the current trial.
13. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the sponsor or Contract Research Organization (CRO)
14. Having received another investigational drug or been participated in an investigational drug or device study within 30 days before administration of the investigational drug.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06570668
Study Brief:
Protocol Section:
NCT06570668