Healthy AdultsPhase 1NCT06589635
A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole in Healthy, Adult Subjects
A Phase 1 study testing ADC-189 and Itraconazole in people with Healthy Adults, run by Jiaxing AnDiCon Biotech Co.,Ltd at 1 site in China.
Trial 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 screening assessments within 14 days before the first dose of ADC189. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- ADC-189 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2024to 11 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affilicated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
About this study
Official title: A Single-center, Open-label and Sequential-dosing Clinical Trial Investigating the Drug Interaction Between ADC-189 Tablet and Itraconazole Capsule in Healthy Adult Subjects
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 screening assessments within 14 days before the first dose of ADC189. Participants will be admitted to the clinical pharmacology center (CPC) and complete 2 periods of treatments. On Day 1 and 26, each participant will receive a single oral dose of ADC189 (45mg), under fasting condition On Day 22, all participants will receive oral doses of itraconazole 200 mg (bid), after meal. From Day 23 to Day 25, and Day 26-D39, participants will receive itraconazole 200 mg(qd). Blood and safety assessments will continue for 336-hours after dosing on Day 1 and Day 26. Participants will receive a telephone follow-up on D47 (±3) days for a final visit.
- Conditions
- Healthy Adults
- Being tested
- ADC-189 and Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADC-189 and ItraconazoleDrug
Also called Part 1: Single dose of ADC-189; Part 2: Itraconazole with single dose of ADC-189
Part 1:
Day 1, fasting condition, 45 mg ADC189, administered orally
Part 2:
Day 22, 200 mg itraconazole bid, taken orally after meals. Day 23-Day 25, 200 mg itraconazole was taken orally after meals. Day 26, 45 mg ADC-189 and 200 mg itraconazole was taken orally after meals. Day 27-Day 39, 200 mg itraconazole was taken orally after meals.
| Study group | Role | What they receive |
|---|---|---|
| ADC-189 and itraconazole | Experimental | Part 1: Single dose of ADC-189
Part 2: Itraconazole with single dose of ADC-189 Receives: Drug: ADC-189 and Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC[0-∞] of ADC-189
Pharmacokinetics (PK) parameter: Area under the curve from time 0 hour to ∞
Measured: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
Cmax of ADC-189
PK parameter: Maximum observed concentration
Measured: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
AUC[0-t] of ADC-189
PK parameter: Area under the curve from time 0 to 336 hour
Measured: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
Adverse events (AEs)
Number of subjects reporting AEs
Measured: Day 1 to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Jul 2024
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiaxing AnDiCon Biotech Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huan Zhou, Principal investigator, The First Affilicated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589635
- Sponsor's protocol ID
- 2023-ADC189-I-002
- Status last verified
- Jun 2024
- First submitted
- 6 Sep 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label and Sequential-dosing Clinical Trial Investigating the Drug Interaction Between ADC-189 Tablet and Itraconazole Capsule in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06589635
- Acronym / sponsor ID
- 2023-ADC189-I-002
- Conditions
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jiaxing AnDiCon Biotech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 screening assessments within 14 days before the first dose of ADC189. Participants will be admitted to the clinical pharmacology center (CPC) and complete 2 periods of treatments. On Day 1 and 26, each participant will receive a single oral dose of ADC189 (45mg), under fasting condition On Day 22, all participants will receive oral doses of itraconazole 200 mg (bid), after meal. From Day 23 to Day 25, and Day 26-D39, participants will receive itraconazole 200 mg(qd). Blood and safety assessments will continue for 336-hours after dosing on Day 1 and Day 26. Participants will receive a telephone follow-up on D47 (±3) days for a final visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADC-189 and itraconazole | Experimental | Drug: ADC-189 and ItraconazolePart 1: Single dose of ADC-189 Part 2: Itraconazole with single dose of ADC-189 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADC-189 and ItraconazoleAlso: Part 1: Single dose of ADC-189; Part 2: Itraconazole with single dose of ADC-189Part 1: Day 1, fasting condition, 45 mg ADC189, administered orally Part 2: Day 22, 200 mg itraconazole bid, taken orally after meals. Day 23-Day 25, 200 mg itraconazole was taken orally after meals. Day 26, 45 mg ADC-189 and 200 mg itraconazole was taken orally after meals. Day 27-Day 39, 200 mg itraconazole was taken orally after meals. | Drug | ADC-189 and itraconazole |
Primary outcome
AUC[0-∞] of ADC-189
Time frame: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
Pharmacokinetics (PK) parameter: Area under the curve from time 0 hour to ∞
Cmax of ADC-189
Time frame: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
PK parameter: Maximum observed concentration
AUC[0-t] of ADC-189
Time frame: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
PK parameter: Area under the curve from time 0 to 336 hour
Adverse events (AEs)
Time frame: Day 1 to Day 43
Number of subjects reporting AEs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Adults
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huan Zhou principal investigator
The First Affilicated Hospital of Bengbu Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADC-189 and Itraconazole in people with Healthy Adults, run by Jiaxing AnDiCon Biotech Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC[0-∞] of ADC-189 (time frame: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.