Mass Balance Study in Healthy SubjectsPhase 1NCT05841940
Mass Balance Study of [14C]HLX208 in China Healthy Subjects
A Phase 1 study testing [14C]HLX208 in people with Mass Balance Study in Healthy Subjects, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
Mass Balance Study of [14C]HLX208 in China Healthy Subjects. 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
- Mass Balance Study in Healthy Subjects
- What is being tested?
- [14C]HLX208
- 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
- 17 Jun 2023to 15 Dec 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
- Healthy male subjects between the ages of 18 and 45 years (inclusive).
- Subjects weighing ≥ 50 kg and Body Mass Index of 18.0 to 32.0 kg/m2.
- No sperm donation or fertility plan during the study and within 12 months after the end of the study.
- Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.
Who cannot join
- Known history of drug or food allergy.
- Known medical history judged by the investigator as not suitable for the study.
- Has laboratory or physical examination abnormalities during the screening period.
- Has a positive test for, HBV，HCV，HIV，or syphilis.
- Has drug abuse history or positive drug abuse test results.
- Has diseases affecting the absorption, distribution, metabolism, and excretion of oral drugs.
- Has any other conditions judged by the investigator as not suitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Mass Balance Study of [14C]HLX208 in China Healthy Subjects.
Read the detailed description
A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]HLX208.
- Conditions
- Mass Balance Study in Healthy Subjects
- Being tested
- [14C]HLX208
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]HLX208Drug
Carbon-14 labeled HLX208
| Study group | Role | What they receive |
|---|---|---|
| [14C]HLX208 | Experimental | Single oral dose of 450mg [14C]HLX208 suspension. Receives: Drug: [14C]HLX208 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance recovery of total radioactivity in urine and fecal samples.
Mass balance recovery of total radioactivity in urine and fecal samples.
Measured: Up to 336 hours post dose.
Total radioactivity in plasma PK: Cmax
Maximum plasma concentration
Measured: Up to 240 hours post dose.
Total radioactivity in plasma PK: Tmax
Time for Cmax
Measured: Up to 240 hours post dose.
Total radioactivity in plasma PK: AUC0-t
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration.
Measured: Up to 240 hours post dose.
Total radioactivity in plasma PK: AUC0-∞
Area under the plasma concentration time profile from time 0 to infinity.
Measured: Up to 240 hours post dose.
Total rradioactivity in plasma PK: t1/2
Elimination half-life.
Measured: Up to 240 hours post dose.
Total radioactivity in plasma PK: CL/F
Drug clearance.
Measured: Up to 240 hours post dose.
Total radioactivity in plasma PK: Vz/F
Apparent volume of distribution following oral administration.
Measured: Up to 240 hours post dose.
Secondary outcomes (6)
HLX208 and metabolite PK: Cmax
Maximum plasma concentration
Measured: Up to 240 hours post dose.
HLX208 and metabolite PK: Tmax
Time for Cmax
Measured: Up to 240 hours post dose.
HLX208 and metabolite PK: AUC0-t
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration.
Measured: Up to 240 hours post dose.
HLX208 and metabolite PK: AUC0-∞
Area under the plasma concentration time profile from time 0 to infinity.
Measured: Up to 240 hours post dose.
HLX208 and metabolite PK: t1/2
Elimination half-life.
Measured: Up to 240 hours post dose.
Adverse events
Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug.
Measured: Screening up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start17 Jun 2023
- Primary completion15 Jul 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mass Balance Study in Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe 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
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, Dr., Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841940
- Sponsor's protocol ID
- HLX208-PK-002
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Balance Study of [14C]HLX208 in China Healthy Subjects
- ClinicalTrials.gov ID
- NCT05841940
- Acronym / sponsor ID
- HLX208-PK-002
- Conditions
- Mass Balance Study in Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 3 May 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.
Mass Balance Study of [14C]HLX208 in China Healthy Subjects.
Detailed description
A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]HLX208.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]HLX208 | Experimental | Drug: [14C]HLX208Single oral dose of 450mg [14C]HLX208 suspension. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects between the ages of 18 and 45 years (inclusive).
- Subjects weighing ≥ 50 kg and Body Mass Index of 18.0 to 32.0 kg/m2.
- No sperm donation or fertility plan during the study and within 12 months after the end of the study.
- Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.
Key exclusion criteria (7 listed)
- Known history of drug or food allergy.
- Known medical history judged by the investigator as not suitable for the study.
- Has laboratory or physical examination abnormalities during the screening period.
- Has a positive test for, HBV，HCV，HIV，or syphilis.
- Has drug abuse history or positive drug abuse test results.
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]HLX208Carbon-14 labeled HLX208 | Drug | [14C]HLX208 |
Primary outcome
Mass balance recovery of total radioactivity in urine and fecal samples.
Time frame: Up to 336 hours post dose.
Mass balance recovery of total radioactivity in urine and fecal samples.
Total radioactivity in plasma PK: Cmax
Time frame: Up to 240 hours post dose.
Maximum plasma concentration
Total radioactivity in plasma PK: Tmax
Time frame: Up to 240 hours post dose.
Time for Cmax
Total radioactivity in plasma PK: AUC0-t
Time frame: Up to 240 hours post dose.
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration.
Total radioactivity in plasma PK: AUC0-∞
Time frame: Up to 240 hours post dose.
Area under the plasma concentration time profile from time 0 to infinity.
Total rradioactivity in plasma PK: t1/2
Time frame: Up to 240 hours post dose.
Elimination half-life.
Total radioactivity in plasma PK: CL/F
Time frame: Up to 240 hours post dose.
Drug clearance.
Total radioactivity in plasma PK: Vz/F
Time frame: Up to 240 hours post dose.
Apparent volume of distribution following oral administration.
6 secondary outcomes
HLX208 and metabolite PK: Cmax
Time frame: Up to 240 hours post dose.
HLX208 and metabolite PK: Tmax
Time frame: Up to 240 hours post dose.
HLX208 and metabolite PK: AUC0-t
Time frame: Up to 240 hours post dose.
HLX208 and metabolite PK: AUC0-∞
Time frame: Up to 240 hours post dose.
HLX208 and metabolite PK: t1/2
Time frame: Up to 240 hours post dose.
Adverse events
Time frame: Screening up to Day 15
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 16 Jan 2024.
- 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.
Liyan Miao, Dr. principal investigator
The First Affiliated Hospital of Soochow University
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]HLX208 in people with Mass Balance Study in Healthy Subjects, run by Shanghai Henlius Biotech 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 7 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 16 Jan 2024. 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?
Mass balance recovery of total radioactivity in urine and fecal samples. (time frame: Up to 336 hours post dose.). The study lists 8 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 16 Jan 2024.