Healthy SubjectsPhase 1NCT05626179
A Study of [14C]IBI351 in Healthy Subjects
A Phase 1 study testing [14C] IBI351 in people with Healthy Subjects, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This study is to evaluate the mass balance of single oral dose of [14C] IBI351 in healthy subjects. Six to eight healthy male subjects were planned to be enrolled. After passing the screening, subjects were admitted to hospital and received training on medication, urine and feces collection and other procedures to… 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?
- [14C] IBI351
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2023to 18 May 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, and fully understand the content, process and possible adverse reactions of the trial.
- 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).
- Vital signs, physical examination, laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation, etc.), chest radiography, 12-lead ECG and other results were unremarkable; or abnormal examination results but judged by the investigator as clinically insignificant.
Who cannot join
- allergic constitution; known hypersensitivity to any component of the test drug or its preparation.
- have special requirements for diet and cannot abide by the unified diet; or lactose intolerance.
- history of dysphagia or any gastrointestinal disease that affects drug absorption.
- blood donation or massive blood loss (> 200 mL) within 3 months before screening, or blood transfusion within 1 month.
- Have taken an investigational product or participated in any clinical trial within 3 months before taking the study drug.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: A Mass Balance Study of [14C]IBI351 in Healthy Male Chinese Subjects
This study is to evaluate the mass balance of single oral dose of [14C] IBI351 in healthy subjects. Six to eight healthy male subjects were planned to be enrolled. After passing the screening, subjects were admitted to hospital and received training on medication, urine and feces collection and other procedures to ensure that they could perform relevant operations according to the protocol and SOP requirements. On the evening before medication, the patient had standard meals, and fasted uniformly overnight. On D1, the suspension containing recommended dose of [14C] IBI351 was administered in the morning on an empty stomach. Subjects have standardized meal during the trial and blood, urine, and feces samples were collected and safety laboratory tests were performed as scheduled.
- Conditions
- Healthy Subjects
- Being tested
- [14C] IBI351
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] IBI351Drug
The oral formulation of [14C] IBI351 was formulated as a suspension for subjects to take orally in drinking water under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| [14C] IBI351 | Other | Recommended dose of [14C] IBI351 Receives: Drug: [14C] IBI351 |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative recovery of total radioactivity in excreta (urine and feces)
Measured: approximately 30 days after first dose
percentage of metabolite in total exposure AUC in plasma (% AUC)
Measured: approximately 30 days after first dose
percentage of each metabolite in urine to administered dose (% of administered dose)
Measured: approximately 30 days after first dose
Percentage of each metabolite in feces to administered dose (% of administered dose)
Measured: approximately 30 days after first dose
total radioactivity ratio for whole blood/plasma
Measured: approximately 30 days after first dose
maximum concentrations (Cmax ) for total plasma radioactivity
Measured: approximately 30 days after first dose
time-to-maximum concentration (Tmax) for total plasma radioactivity
Measured: approximately 30 days after first dose
half-life (t1/2) for total plasma radioactivity
Measured: approximately 30 days after first dose
area under the curve from time 0 to the last time point (AUC0-t) for total plasma radioactivityarea under the curve from time 0 to the last time point (AUC0-t) for total plasma radioactivity
Measured: approximately 30 days after first dose
area under the curve from time 0 to infinity(AUC0-inf) for total plasma radioactivity
Measured: approximately 30 days after first dose
apparent clearance (CL/F) for total plasma radioactivity
Measured: approximately 30 days after first dose
apparent volume of distribution(Vz/F) for total plasma radioactivity
Measured: approximately 30 days after first dose
Secondary outcomes (16)
maximum concentrations (Cmax ) for plasma
Measured: approximately 30 days after first dose
time-to-maximum concentration (Tmax) for plasma
Measured: approximately 30 days after first dose
area under the curve from time 0 to the last time point (AUC0-t) for plasma
Measured: approximately 30 days after first dose
area under the curve from time 0 to infinity(AUC0-inf) for plasma
Measured: approximately 30 days after first dose
apparent clearance (CL/F) for plasma
Measured: approximately 30 days after first dose
apparent volume of distribution(Vz/F) for plasma
Measured: approximately 30 days after first dose
adverse events
Measured: approximately 30 days after first dose
abnormality in vital signs
Measured: approximately 30 days after first dose
abnormality in ECG parameters
Measured: approximately 30 days after first dose
abnormality in physical examination
Measured: approximately 30 days after first dose
abnormality in hematology parameters
Measured: approximately 30 days after first dose
abnormality in clinical chemistry parameters
Measured: approximately 30 days after first dose
abnormality in routine urinalysis parameters
Measured: approximately 30 days after first dose
abnormality in routine stool parameters
Measured: approximately 30 days after first dose
abnormality in coagulation parameters
Measured: approximately 30 days after first dose
abnormality in Troponin T (TnT)
Measured: approximately 30 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start18 Feb 2023
- Primary completion30 Mar 2023
- Study completion18 May 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT05626179
- Sponsor's protocol ID
- CIBI351P002
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2022
- Last updated
- 27 Dec 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 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mass Balance Study of [14C]IBI351 in Healthy Male Chinese Subjects
- ClinicalTrials.gov ID
- NCT05626179
- Acronym / sponsor ID
- CIBI351P002
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 23 Nov 2022 (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 is to evaluate the mass balance of single oral dose of [14C] IBI351 in healthy subjects. Six to eight healthy male subjects were planned to be enrolled. After passing the screening, subjects were admitted to hospital and received training on medication, urine and feces collection and other procedures to ensure that they could perform relevant operations according to the protocol and SOP requirements. On the evening before medication, the patient had standard meals, and fasted uniformly overnight. On D1, the suspension containing recommended dose of [14C] IBI351 was administered in the morning on an empty stomach. Subjects have standardized meal during the trial and blood, urine, and feces samples were collected and safety laboratory tests were performed as scheduled.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] IBI351 | Other | Drug: [14C] IBI351Recommended dose of [14C] IBI351 |
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, and fully understand the content, process and possible adverse reactions of the trial.
- 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).
- Vital signs, physical examination, laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation, etc.), chest radiography, 12-lead ECG and other results were unremarkable; or abnormal examination results but judged by the investigator as clinically insignificant.
Key exclusion criteria (5 listed)
- allergic constitution; known hypersensitivity to any component of the test drug or its preparation.
- have special requirements for diet and cannot abide by the unified diet; or lactose intolerance.
- history of dysphagia or any gastrointestinal disease that affects drug absorption.
- blood donation or massive blood loss (> 200 mL) within 3 months before screening, or blood transfusion within 1 month.
- Have taken an investigational product or participated in any clinical trial within 3 months before taking the study drug.
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 |
|---|---|---|
| [14C] IBI351The oral formulation of [14C] IBI351 was formulated as a suspension for subjects to take orally in drinking water under fasting conditions | Drug | [14C] IBI351 |
Primary outcome
cumulative recovery of total radioactivity in excreta (urine and feces)
Time frame: approximately 30 days after first dose
percentage of metabolite in total exposure AUC in plasma (% AUC)
Time frame: approximately 30 days after first dose
percentage of each metabolite in urine to administered dose (% of administered dose)
Time frame: approximately 30 days after first dose
Percentage of each metabolite in feces to administered dose (% of administered dose)
Time frame: approximately 30 days after first dose
total radioactivity ratio for whole blood/plasma
Time frame: approximately 30 days after first dose
maximum concentrations (Cmax ) for total plasma radioactivity
Time frame: approximately 30 days after first dose
time-to-maximum concentration (Tmax) for total plasma radioactivity
Time frame: approximately 30 days after first dose
half-life (t1/2) for total plasma radioactivity
Time frame: approximately 30 days after first dose
area under the curve from time 0 to the last time point (AUC0-t) for total plasma radioactivityarea under the curve from time 0 to the last time point (AUC0-t) for total plasma radioactivity
Time frame: approximately 30 days after first dose
area under the curve from time 0 to infinity(AUC0-inf) for total plasma radioactivity
Time frame: approximately 30 days after first dose
apparent clearance (CL/F) for total plasma radioactivity
Time frame: approximately 30 days after first dose
apparent volume of distribution(Vz/F) for total plasma radioactivity
Time frame: approximately 30 days after first dose
16 secondary outcomes
maximum concentrations (Cmax ) for plasma
Time frame: approximately 30 days after first dose
time-to-maximum concentration (Tmax) for plasma
Time frame: approximately 30 days after first dose
area under the curve from time 0 to the last time point (AUC0-t) for plasma
Time frame: approximately 30 days after first dose
area under the curve from time 0 to infinity(AUC0-inf) for plasma
Time frame: approximately 30 days after first dose
apparent clearance (CL/F) for plasma
Time frame: approximately 30 days after first dose
apparent volume of distribution(Vz/F) for plasma
Time frame: approximately 30 days after first dose
adverse events
Time frame: approximately 30 days after first dose
abnormality in vital signs
Time frame: approximately 30 days after first dose
abnormality in ECG parameters
Time frame: approximately 30 days after first dose
abnormality in physical examination
Time frame: approximately 30 days after first dose
abnormality in hematology parameters
Time frame: approximately 30 days after first dose
abnormality in clinical chemistry parameters
Time frame: approximately 30 days after first dose
abnormality in routine urinalysis parameters
Time frame: approximately 30 days after first dose
abnormality in routine stool parameters
Time frame: approximately 30 days after first dose
abnormality in coagulation parameters
Time frame: approximately 30 days after first dose
abnormality in Troponin T (TnT)
Time frame: approximately 30 days after first dose
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 27 Dec 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 [14C] IBI351 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 5 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 27 Dec 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?
cumulative recovery of total radioactivity in excreta (urine and feces) (time frame: approximately 30 days after first dose). The study lists 12 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 27 Dec 2023.