Healthy VolunteerPhase 1NCT06428903
Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose
A Phase 1 study testing ADC189 tablet, ADC189 granules and ADC189 180mg in people with Healthy Volunteer, run by Jiaxing AnDiCon Biotech Co.,Ltd at 1 site in China.
Trial summary
Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ADC189 tablet, ADC189 granules and ADC189 180mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2024to 22 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy male subjects aged 18-45 years old
- 2. Male subjects weight over 50 kg
Who cannot join
- 1. Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
- 2. Have a history of drug abuse in the past five years or use drugs in the three months prior to screening
- 3. Blood donation or blood loss > 400 mL in 3 months before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Study of ADC189 Bioavailability Between Tablet and Granule in Healthy Chinese Adult Male Subjects, and the Safety and Pharmacokinetics of Ultra-high Dose ADC189
Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food.
The purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects.
Read the detailed description
In Part 1 study, a total of 32 subjects were randomly divided into two groups, A and B, with 16 subjects in each group. After a 28-day screening period, on the first day of Period 1 (D1), subjects in group A took ADC189 granules (a single oral dose, 45mg), and subjects in group B took ADC189 tablets (a single oral dose, 45mg), all subjects were under fasted conditon. In Period 2, two groups will change to the fomulation which is different in Period 1 respectively, and all the steps will keep the same as Period 1. Each period lasts for 15 days, and have a 7-day interval between 2 periods. Blood samples will be taken, pharmacokinetic and saftey profiles will be observed.
In Part 2 study, the ultra high dose of ADC189 (a single oral dose, 180mg) will applied in 8 healty adult male subjects. The pharmacokinetic and saftey profiles will be observed during the following 15 days, and blood sample will be taken.
- Conditions
- Healthy Volunteer
- Being tested
- ADC189 tablet, ADC189 granules, ADC189 180mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADC189 tabletDrug
ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study)
ADC189 granulesDrug
ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)
ADC189 180mgDrug
ADC189 tablet, 180 mg, single oral dose. (Part 2 study)
| Study group | Role | What they receive |
|---|---|---|
| ADC189 tablet Group A | Experimental | 16 patients. Receives: Drug: ADC189 tablet; Drug: ADC189 granules |
| ADC189 granules Group B | Experimental | 16 patients. Receives: Drug: ADC189 tablet; Drug: ADC189 granules |
| ADC189 180mg Group | Experimental | 8 patients. Receives: Drug: ADC189 180mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADC189 Granules
ADC189 plasma exposure, area under the concentration-time curve
Measured: 15 days
ADC189 Tablet
ADC189 plasma exposure, area under the concentration-time curve
Measured: 15 days
ADC189 Ultra high dose
Single dose of 180mg ADC189 tablet plasma exposure, area under the concentration-time curve
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 posted24 May 2024
- Study start12 Mar 2024
- Primary completion22 Sep 2024
- Study completion22 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT06428903
- Sponsor's protocol ID
- ADC-DNXV-189-GR
- Status last verified
- May 2024
- First submitted
- 19 May 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
- A Comparison Study of ADC189 Bioavailability Between Tablet and Granule in Healthy Chinese Adult Male Subjects, and the Safety and Pharmacokinetics of Ultra-high Dose ADC189
- ClinicalTrials.gov ID
- NCT06428903
- Acronym / sponsor ID
- ADC-DNXV-189-GR
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jiaxing AnDiCon Biotech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 22 Sep 2024 (actual)
- Study completion
- 22 Sep 2024 (actual)
- First posted
- 24 May 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.
Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food.
The purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects.
Detailed description
In Part 1 study, a total of 32 subjects were randomly divided into two groups, A and B, with 16 subjects in each group. After a 28-day screening period, on the first day of Period 1 (D1), subjects in group A took ADC189 granules (a single oral dose, 45mg), and subjects in group B took ADC189 tablets (a single oral dose, 45mg), all subjects were under fasted conditon. In Period 2, two groups will change to the fomulation which is different in Period 1 respectively, and all the steps will keep the same as Period 1. Each period lasts for 15 days, and have a 7-day interval between 2 periods. Blood samples will be taken, pharmacokinetic and saftey profiles will be observed.
In Part 2 study, the ultra high dose of ADC189 (a single oral dose, 180mg) will applied in 8 healty adult male subjects. The pharmacokinetic and saftey profiles will be observed during the following 15 days, and blood sample will be taken.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ADC189 tablet Group A | Experimental | Drug: ADC189 tablet, Drug: ADC189 granules16 patients. |
| ADC189 granules Group B | Experimental | Drug: ADC189 tablet, Drug: ADC189 granules16 patients. |
| ADC189 180mg Group | Experimental | Drug: ADC189 180mg8 patients. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Healthy male subjects aged 18-45 years old
- 2. Male subjects weight over 50 kg
Key exclusion criteria (3 listed)
- 1. Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
- 2. Have a history of drug abuse in the past five years or use drugs in the three months prior to screening
- 3. Blood donation or blood loss > 400 mL in 3 months before screening
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 |
|---|---|---|
| ADC189 tabletADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study) | Drug | ADC189 granules Group B, ADC189 tablet Group A |
| ADC189 granulesADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study) | Drug | ADC189 granules Group B, ADC189 tablet Group A |
| ADC189 180mgADC189 tablet, 180 mg, single oral dose. (Part 2 study) | Drug | ADC189 180mg Group |
Primary outcome
ADC189 Granules
Time frame: 15 days
ADC189 plasma exposure, area under the concentration-time curve
ADC189 Tablet
Time frame: 15 days
ADC189 plasma exposure, area under the concentration-time curve
ADC189 Ultra high dose
Time frame: 15 days
Single dose of 180mg ADC189 tablet plasma exposure, area under the concentration-time curve
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 Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
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 recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 tablet, ADC189 granules and ADC189 180mg in people with Healthy Volunteer, 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 2 inclusion and 3 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?
ADC189 Granules (time frame: 15 days). The study lists 3 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.