Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of CDD-2101 in Health Volunteers
Lead Sponsor:
Centre for Chinese Herbal Medicine Drug Development Limited
Conditions:
Constipation - Functional
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a single-center, randomized, double-blind, placebo-controlled, single-dose study to confirm the safety, tolerability and pharmacokinetic profile of CDD-2101 in healthy subjects. A total of 20 ...
Detailed Description
A total of 20 eligible healthy subjects aged 18-65 years, body weight of 50kg or more with a BMI of 18.5-29.9 kg/m2 will be hospitalized and randomized in a 1:1:1:1:1 ratio (N=4/group) to receive one ...
Eligibility Criteria
Inclusion
- An individual must meet all the criteria below to be eligible for participation in this study:
- Male or female
- Aged 18-65 years (inclusive)
- Body weight of 50kg or more
- BMI 18.5-29.9 kg/m2 (inclusive)
- 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)
- Normal renal function: glomerular filtration rate (GFR) ≥ 90 mL/min/1.7m2
- Understand the study procedures and agree to participate by providing written informed consent
- Be willing and able to comply with all study procedures and restrictions
- 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
- 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
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of conception for those participating in clinical study
Exclusion
- An individual who meets any of the following criteria will be excluded:
- Pregnant, trying to become pregnant or lactating
- Use of any prescription, non-prescription drug and investigational drug within 30 days prior to administration of the study drug
- Has a substance abuse disorder
- 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
- Has a history of cancer (malignancy)
- Has a known hypersensitivity to any component of the formulation of CDD-2101, its related compounds or placebo, or allergy to Chinese herbal medicine
- 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
- Had major surgery, donated, or lost 1 unit of blood (approximately 500 mL) within 8 weeks before administration of the investigational drug
- Diagnosis of bowel disorders based on the Rome IV criteria
- Has a history of positive for hepatitis B, hepatitis C or HIV
- 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)
- 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.
- Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the sponsor or Contract Research Organization (CRO)
- Having received another investigational drug or been participated in an investigational drug or device study within 30 days before administration of the investigational drug.
Key Trial Info
Start Date :
May 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06570668
Start Date
May 29 2024
End Date
July 12 2024
Last Update
August 26 2024
Active Locations (1)
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1
Biotrial Inc
Newark, New Jersey, United States, 07103