Status:
COMPLETED
A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole in Healthy, Adult Subjects
Lead Sponsor:
Jiaxing AnDiCon Biotech Co.,Ltd
Conditions:
Healthy Adults
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of ADC189 in healthy adults. Participants in this study will complete ...
Eligibility Criteria
Inclusion
- Sign informed consent, be capable of and willing to comply with study restrictions and procedures.
- Healthy adult subjects aged 18 to 55 years.
- Weight \>=50kg for males, and \>=45kg for females, BMI 19-26 kg/m\^2.
- No clinical significance in physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal ultrasound, and chest X-ray examination.
Exclusion
- Subjects who participated in other drug trials within 3 months before screening
- Hospital admission or major surgery within 4 weeks prior to screening or a preplanned hospital admission during study participation
- Donated or lost ≥400 mL of blood in the previous 3 months before screening
- Have a history of allergic diseases (asthma, urticaria, eczema, etc.), or food allergies
- A history of drug abuse in the past five years
- Any condition or finding that in the Investigator's opinion would put the participant or study conduct at risk if the participant were to participate in the study
- Unable to complete this study for other reasons or the Investigator believes that he or she should be excluded
Key Trial Info
Start Date :
July 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06589635
Start Date
July 16 2024
End Date
September 11 2024
Last Update
January 20 2025
Active Locations (1)
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1
The First Affilicated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233004