Healthy SubjectsPhase 1NCT05699993
A Study of IBI351 in Healthy Subjects
A Phase 1 study testing Itraconazole, IBI351 and Dextromethorphan in people with Healthy Subjects, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Itraconazole, IBI351 and Dextromethorphan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2023to 16 Oct 2023
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
- Healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
- Body weight is not less than 50 kg, and body mass index (BMI) is in the range of 19 ~ 26 kg/m2 (including both ends).
- Physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), thyroid function, 12-lead electrocardiogram, chest CT, abdominal ultrasound (hepatobiliary, pancreatic, spleen and kidney), echocardiography (only applicable to Cohort 1 subjects) showed no abnormalities; or abnormal test results but judged as normal or clinically insignificant by the investigator.
Who cannot join
- have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication.
- hepatitis B surface antigen HBsAg positive.
- hepatitis C virus antibody positive.
- positive AIDS antigen/antibody or Treponema pallidum antibody.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, 2-cycle Clinical Study to Evaluate the Drug Interaction Between Itraconazole or Dextromethorphan and IBI351 in Healthy Subjects
This is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort.
- Conditions
- Healthy Subjects
- Being tested
- Itraconazole, IBI351, Dextromethorphan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
Itraconazole was administered orally
IBI351Drug
IBI351 was administered orally
DextromethorphanDrug
Dextromethorphan was administered orally
| Study group | Role | What they receive |
|---|---|---|
| IBI351+ itraconazole | Other | Enrolled subjects were treated with IBI351 on an empty stomach on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 3 to Day 6. IBI351 and itraconazole were administered simultaneously on an empty stomach on Day 7. On Day 8, itraconazole was orally administered once after a standard meal. Receives: Drug: Itraconazole; Drug: IBI351 |
| IBI351+ dextromethorphan | Other | Enrolled subjects were orally administered dextromethorphan on an empty stomach on Day 1. IBI351 and dextromethorphan were orally administered simultaneously on an empty stomach on Day 3, followed by IBI351 12 hours later. Receives: Drug: IBI351; Drug: Dextromethorphan |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum concentrations (Cmax ) for IBI351
Measured: approximately 10 days
maximum concentrations (Cmax ) for dextromethorphan
Measured: approximately 10 days
area under the curve from time 0 to infinity(AUC0-inf) for IBI351
Measured: approximately 10 days
area under the curve from time 0 to infinity(AUC0-inf) for dextromethorphan
Measured: approximately 10 days
Secondary outcomes (17)
time-to-maximum concentration (Tmax) for IBI351
Measured: approximately 10 days
half-life (t1/2) for IBI351
Measured: approximately 10 days
area under the curve from time 0 to time (AUC0-t) for IBI351
Measured: approximately 10 days
apparent clearance (CL/F) for IBI351
Measured: approximately 10 days
apparent volume of distribution(Vz/F) for IBI351
Measured: approximately 10 days
time-to-maximum concentration (Tmax) for dextromethorphan
Measured: approximately 10 days
half-life (t1/2) for dextromethorphan
Measured: approximately 10 days
area under the curve from time 0 to time (AUC0-t) for dextromethorphan
Measured: approximately 10 days
apparent clearance (CL/F) for dextromethorphan
Measured: approximately 10 days
apparent volume of distribution(Vz/F) for dextromethorphan
Measured: approximately 10 days
area under the curve for dextrorphan
Measured: approximately 10 days
maximum concentrations (Cmax ) for dextrorphan
Measured: approximately 10 days
number of participants with abnormal hematology tests
Measured: approximately 10 days
number of participants with abnormal chemistry parameters
Measured: approximately 10 days
number of participants with abnormal vital signs
Measured: approximately 10 days
number of participants with abnormal physical examination findings
Measured: approximately 10 days
number of participants with abnormal ECG readings
Measured: approximately 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start10 Mar 2023
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699993
- Sponsor's protocol ID
- CIBI351P003
- Status last verified
- Oct 2023
- First submitted
- 17 Jan 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, 2-cycle Clinical Study to Evaluate the Drug Interaction Between Itraconazole or Dextromethorphan and IBI351 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05699993
- Acronym / sponsor ID
- CIBI351P003
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 26 Jan 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 is an open-label, two-cycle clinical study to evaluate the drug interaction between itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12 healthy male subjects were planned to be enrolled in each cohort.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI351+ itraconazole | Other | Drug: Itraconazole, Drug: IBI351Enrolled subjects were treated with IBI351 on an empty stomach on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 3 to Day 6. IBI351 and itraconazole were administered simultaneously on an empty stomach on Day 7. On Day 8, itraconazole was orally administered once after a standard meal. |
| IBI351+ dextromethorphan | Other | Drug: IBI351, Drug: DextromethorphanEnrolled subjects were orally administered dextromethorphan on an empty stomach on Day 1. IBI351 and dextromethorphan were orally administered simultaneously on an empty stomach on Day 3, followed by IBI351 12 hours later. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Voluntarily sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol.
- Healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
- Body weight is not less than 50 kg, and body mass index (BMI) is in the range of 19 ~ 26 kg/m2 (including both ends).
- Physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), thyroid function, 12-lead electrocardiogram, chest CT, abdominal ultrasound (hepatobiliary, pancreatic, spleen and kidney), echocardiography (only applicable to Cohort 1 subjects) showed no abnormalities; or abnormal test results but judged as normal or clinically insignificant by the investigator.
Key exclusion criteria (4 listed)
- have taken any products containing alcohol or have a positive alcohol breath test (≥ 20 mg/100 ml) within 24 hours before taking study medication.
- hepatitis B surface antigen HBsAg positive.
- hepatitis C virus antibody positive.
- positive AIDS antigen/antibody or Treponema pallidum antibody.
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 |
|---|---|---|
| ItraconazoleItraconazole was administered orally | Drug | IBI351+ itraconazole |
| IBI351IBI351 was administered orally | Drug | IBI351+ dextromethorphan, IBI351+ itraconazole |
| DextromethorphanDextromethorphan was administered orally | Drug | IBI351+ dextromethorphan |
Primary outcome
maximum concentrations (Cmax ) for IBI351
Time frame: approximately 10 days
maximum concentrations (Cmax ) for dextromethorphan
Time frame: approximately 10 days
area under the curve from time 0 to infinity(AUC0-inf) for IBI351
Time frame: approximately 10 days
area under the curve from time 0 to infinity(AUC0-inf) for dextromethorphan
Time frame: approximately 10 days
17 secondary outcomes
time-to-maximum concentration (Tmax) for IBI351
Time frame: approximately 10 days
half-life (t1/2) for IBI351
Time frame: approximately 10 days
area under the curve from time 0 to time (AUC0-t) for IBI351
Time frame: approximately 10 days
apparent clearance (CL/F) for IBI351
Time frame: approximately 10 days
apparent volume of distribution(Vz/F) for IBI351
Time frame: approximately 10 days
time-to-maximum concentration (Tmax) for dextromethorphan
Time frame: approximately 10 days
half-life (t1/2) for dextromethorphan
Time frame: approximately 10 days
area under the curve from time 0 to time (AUC0-t) for dextromethorphan
Time frame: approximately 10 days
apparent clearance (CL/F) for dextromethorphan
Time frame: approximately 10 days
apparent volume of distribution(Vz/F) for dextromethorphan
Time frame: approximately 10 days
area under the curve for dextrorphan
Time frame: approximately 10 days
maximum concentrations (Cmax ) for dextrorphan
Time frame: approximately 10 days
number of participants with abnormal hematology tests
Time frame: approximately 10 days
number of participants with abnormal chemistry parameters
Time frame: approximately 10 days
number of participants with abnormal vital signs
Time frame: approximately 10 days
number of participants with abnormal physical examination findings
Time frame: approximately 10 days
number of participants with abnormal ECG readings
Time frame: approximately 10 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 24 Oct 2023.
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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 Itraconazole, IBI351 and Dextromethorphan in people with Healthy Subjects, run by Innovent Biologics (Suzhou) 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 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 24 Oct 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?
maximum concentrations (Cmax ) for IBI351 (time frame: approximately 10 days). 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 24 Oct 2023.