HealthyPhase 1NCT05928988
A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult Subjects
A Phase 1 study testing SHR8554；Itraconazole in people with Healthy, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SHR8554；Itraconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2022to 9 Jun 2022
- 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
- Healthy male and female subjects, aged 18 to 45 years (inclusive).
- Female subjects body weight≥45 kg, male subjects body weight≥50 kg, body mass index (BMI) of 19.0 to 26.0 kg/m2 (inclusive).
- Understand the study procedures in the informed consent form and be willing and able to comply with the protocol.
Who cannot join
- Subjects with a history of drug allergy, or a history of specific allergies, or known allergy to SHR8554 or itraconazole or similar.
- Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study as determined by the investigator.
- Subjects with positive tests for infectious diseases.
- Subjects who have undergone major surgery within 3 months prior to screening or have undergone surgery that could significantly affect the in vivo course or safety evaluation of the study drug.
- History of using any medication within 2 weeks prior to the first dosing.
- Subjects who have received vaccination within 1 month prior to screening or plan to receive vaccination during the trial.
Show all 10Show fewer
- Excessive daily consumption of tea, coffee, grapefruit/grapefruit juice and other special diets in the 1 month prior to screening.
- Subjects with a history of substance abuse, drug use or a positive screening test for substance abuse.
- Female who are pregnant or breastfeeding, or have a positive pregnancy test.
- Subjects who may not be able to complete the study for other reasons or who the investigator believes should not be included.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008
About this study
Official title: A Phase 1, Open-label, Fixed-sequence Study to Estimate the Effects of Multiple-dose Administration of Itraconazole on the Pharmacokinetics of SHR8554 in Healthy Adult Subjects
This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole
- Conditions
- Healthy
- Being tested
- SHR8554；Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR8554；ItraconazoleDrug
Drug: SHR8554 Administered as specified in the treatment arm Drug: Itraconazole Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| SHR8554 and itraconazole | Experimental | SHR8554 will be provided in a solution. Participants will receive 1 mg SHR8554 by intravenous pump on Day 1 and Day 9.
Itraconazole capsules 200 mg orally after meals twice daily for 7 days from Day 4 to Day 10. Receives: Drug: SHR8554；Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax：observed maximum plasma concentration
Measured: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
Measured: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
AUC0-∞：area under the plasma concentration-time curve from time 0 to infinity
Measured: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Tmax：observed time to reach Cmax
Measured: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Vz ：apparent volume of distribution
Measured: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
MRT0-∞：mean residence time from time 0 to infinity
Measured: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Secondary outcomes (4)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Baseline up to Day 18
Incidence of participants with clinical laboratory abnormalities
Measured: Baseline up to Day 18
Incidence of participants with vital signs abnormalities
Measured: Baseline up to Day 18
Incidence of participants with physical exam abnormalities
Measured: Baseline up to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start4 Jan 2022
- Primary completion21 Jan 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928988
- Sponsor's protocol ID
- SHR8554-103
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang L, Jiang H, Huang Y, Li J. Exploring Pharmacokinetic interactions between SHR8554, a micro-opioid receptor biased agonist, and Itraconazole in healthy Chinese subjects. Sci Rep. 2025 Jul 2;15(1):22635. doi: 10.1038/s41598-025-98697-3.
PubMed 40593123
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Fixed-sequence Study to Estimate the Effects of Multiple-dose Administration of Itraconazole on the Pharmacokinetics of SHR8554 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05928988
- Acronym / sponsor ID
- SHR8554-103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 3 Jul 2023 (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 drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR8554 and itraconazole | Experimental | Drug: SHR8554；ItraconazoleSHR8554 will be provided in a solution. Participants will receive 1 mg SHR8554 by intravenous pump on Day 1 and Day 9. Itraconazole capsules 200 mg orally after meals twice daily for 7 days from Day 4 to Day 10. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects, aged 18 to 45 years (inclusive).
- Female subjects body weight≥45 kg, male subjects body weight≥50 kg, body mass index (BMI) of 19.0 to 26.0 kg/m2 (inclusive).
- Understand the study procedures in the informed consent form and be willing and able to comply with the protocol.
Key exclusion criteria (10 listed)
- Subjects with a history of drug allergy, or a history of specific allergies, or known allergy to SHR8554 or itraconazole or similar.
- Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study as determined by the investigator.
- Subjects with positive tests for infectious diseases.
- Subjects who have undergone major surgery within 3 months prior to screening or have undergone surgery that could significantly affect the in vivo course or safety evaluation of the study drug.
- History of using any medication within 2 weeks prior to the first dosing.
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 |
|---|---|---|
| SHR8554；ItraconazoleDrug: SHR8554 Administered as specified in the treatment arm Drug: Itraconazole Administered as specified in the treatment arm | Drug | SHR8554 and itraconazole |
Primary outcome
Cmax：observed maximum plasma concentration
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
AUC0-∞：area under the plasma concentration-time curve from time 0 to infinity
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Tmax：observed time to reach Cmax
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Vz ：apparent volume of distribution
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
MRT0-∞：mean residence time from time 0 to infinity
Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
4 secondary outcomes
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline up to Day 18
Incidence of participants with clinical laboratory abnormalities
Time frame: Baseline up to Day 18
Incidence of participants with vital signs abnormalities
Time frame: Baseline up to Day 18
Incidence of participants with physical exam abnormalities
Time frame: Baseline up to Day 18
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 3 Jul 2023.
- Derived from this study: PubMed 40593123Huang L, Jiang H, Huang Y, Li J. Exploring Pharmacokinetic interactions between SHR8554, a micro-opioid receptor biased agonist, and Itraconazole in healthy Chinese subjects. Sci Rep. 2025 Jul 2;15(1):22635. doi: 10.1038/s41598-025-98697-3.
- Individual participant dataSharing planned: Undecided
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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 SHR8554；Itraconazole in people with Healthy, run by Jiangsu HengRui Medicine 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 10 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 3 Jul 2023. 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：observed maximum plasma concentration (time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05928988, which also lists 1 linked publication.
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 3 Jul 2023.