Influenza Type APhase 1NCT06485401
To Compare the Safety and PK/ PD Characteristics of ADC189 Between Hepatic Impairment and Normal Hepatic Function Subjects
A Phase 1 study testing ADC189 in people with Influenza Type A and Influenza Type B, run by Jiaxing AnDiCon Biotech Co.,Ltd at 1 site in China.
Trial summary
This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of ADC189 in subjects with hepatic impairment compared with subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Type A, Influenza Type B
- What is being tested?
- ADC189
- 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
- 14 Mar 2024to 21 Jun 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) The subjects fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent, and can complete the entire trial process according to the requirements of the trial.
- 2) Age 18-75 years old (including the boundary value), both male and female.
- 3) The body weight of male subjects was ≥50 kg, the body weight of female subjects was ≥45 kg, and the body mass index (BMI) was within the range of 18.0~30.0 kg/m².
Who cannot join
- 1) Known allergic history to test drug components, or allergic constitution, or history of allergic diseases.
- 2) Have malignant tumors, or have a history of malignant tumors within 5 years prior to screening.
- 3) Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening.
- 4) eGFR (CKD-EPI Cr) <60mL/min/1.73m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Phase I, Open-label, Multi-center, Parallel, Single Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of ADC189 in Subjects With Hepatic Impairment (Child-Pugh A and B) Compared With Subjects With Normal Hepatic Function
This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of ADC189 in subjects with hepatic impairment compared with subjects with normal hepatic function.
Read the detailed description
The evaluation of ADC189/ADC189-I07 in mild hepatic insufficiency (Child-Pugh A), moderate hepatic insufficiency (Child-Pugh B) the pharmacokinetic characteristics in subjects, compared with normal liver function subjects, which matched by sex, age, and BMI, in order to provide a scientific basis for a reasonable dosage in patients with liver dysfunction.
- Conditions
- Influenza Type A, Influenza Type B
- Being tested
- ADC189
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADC189Drug
45 mg per tablet, oral administration, single dose.
| Study group | Role | What they receive |
|---|---|---|
| ADC189 to Child-Pugh Class A | Experimental | Subjects with Child-Pugh Class A received a single dose once of ADC189 (45 mg/1 tablet). Receives: Drug: ADC189 |
| ADC189 to normal haptic function (A) | Experimental | Healthy subjects who marched with Group "Child-Pugh Class A", that received a single dose of ADC189 (45 mg/1 tablet). Receives: Drug: ADC189 |
| ADC189 to Child-Pugh Class B | Experimental | Subjects with Child-Pugh Class B received a single dose once of ADC189 (45 mg/1 tablet). Receives: Drug: ADC189 |
| ADC189 to normal haptic function (B) | Experimental | Healthy subjects who marched with Group "Child-Pugh Class B", that received a single dose of ADC189 (45 mg/1 tablet). Receives: Drug: ADC189 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of ADC189/ADC189-I07
Measured: 15 days
AUClast of ADC189/ADC189-I07
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start14 Mar 2024
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Type AStudies 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
- Randomised
- Intervention model
- Parallel groups
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485401
- Sponsor's protocol ID
- 2023-ADC189-I-001
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- An Phase I, Open-label, Multi-center, Parallel, Single Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of ADC189 in Subjects With Hepatic Impairment (Child-Pugh A and B) Compared With Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT06485401
- Acronym / sponsor ID
- 2023-ADC189-I-001
- Conditions
- Influenza Type A, Influenza Type B
- 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
- 14 Mar 2024 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 3 Jul 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 evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of ADC189 in subjects with hepatic impairment compared with subjects with normal hepatic function.
Detailed description
The evaluation of ADC189/ADC189-I07 in mild hepatic insufficiency (Child-Pugh A), moderate hepatic insufficiency (Child-Pugh B) the pharmacokinetic characteristics in subjects, compared with normal liver function subjects, which matched by sex, age, and BMI, in order to provide a scientific basis for a reasonable dosage in patients with liver dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADC189 to Child-Pugh Class A | Experimental | Drug: ADC189Subjects with Child-Pugh Class A received a single dose once of ADC189 (45 mg/1 tablet). |
| ADC189 to normal haptic function (A) | Experimental | Drug: ADC189Healthy subjects who marched with Group "Child-Pugh Class A", that received a single dose of ADC189 (45 mg/1 tablet). |
| ADC189 to Child-Pugh Class B | Experimental | Drug: ADC189Subjects with Child-Pugh Class B received a single dose once of ADC189 (45 mg/1 tablet). |
| ADC189 to normal haptic function (B) | Experimental | Drug: ADC189Healthy subjects who marched with Group "Child-Pugh Class B", that received a single dose of ADC189 (45 mg/1 tablet). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1) The subjects fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent, and can complete the entire trial process according to the requirements of the trial.
- 2) Age 18-75 years old (including the boundary value), both male and female.
- 3) The body weight of male subjects was ≥50 kg, the body weight of female subjects was ≥45 kg, and the body mass index (BMI) was within the range of 18.0~30.0 kg/m².
Key exclusion criteria (4 listed)
- 1) Known allergic history to test drug components, or allergic constitution, or history of allergic diseases.
- 2) Have malignant tumors, or have a history of malignant tumors within 5 years prior to screening.
- 3) Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening.
- 4) eGFR (CKD-EPI Cr) <60mL/min/1.73m2.
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 |
|---|---|---|
| ADC18945 mg per tablet, oral administration, single dose. | Drug | ADC189 to Child-Pugh Class A, ADC189 to Child-Pugh Class B, ADC189 to normal haptic function (A), ADC189 to normal haptic function (B) |
Primary outcome
Cmax of ADC189/ADC189-I07
Time frame: 15 days
AUClast of ADC189/ADC189-I07
Time frame: 15 days
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
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ADC189 in people with Influenza Type A and Influenza Type B, 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 3 inclusion and 4 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?
Cmax of ADC189/ADC189-I07 (time frame: 15 days). The study lists 2 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.