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Healthy Adult SubjectsPhase 1NCT05040113

A Study On Human Mass Balance And Biotransformation

A Phase 1 study testing CBP-307 in people with Healthy Adult Subjects, run by Connect Biopharm LLC at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the absorption,metabolism and excretion of CBP-307 in healthy chinese male 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
Healthy Adult Subjects
What is being tested?
CBP-307
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
4 Sep 2021to 30 Oct 2021
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

  • A healthy male adult
  • Age: 18 to 45 years old (inclusive)
  • Weight: body mass index (BMI) is between 19 and 26 kg/m2(inclusive), and weight of no less than 50 kg
  • Subjects who are willing to sign Informed Consent Form
  • Subjects should be able to communicate well with the investigator and be able to complete the study in accordance with the protocol

Who cannot join

  • -
  • Examinations:
  • Any abnormal and clinically significant findings to physical examination, vital sign, routine laboratory tests (such as hematology, blood chemistry, blood coagulation function, urinalysis, fecal occult blood), thyroid function test, 12-lead ECG, chest CT, abdominal B-ultrasonography (liver, gallbladder, pancreas, spleen and kidney) and so on
  • Heart rate at screening period < 60 bpm, or 12-lead ECG QTcF ≥450 msec
  • Anyone has positive examination result of HBsAg/HBeAg, HCV antibody, HIV antibody and treponema pallidum antibody
  • Screening for novel coronavirus infection: clinically significant abnormity of C-reactive protein, or positive novel coronavirus nucleic acid
Show all 29Show fewer
  • Medication history:
  • Use of any drug that inhibits or induces the function of hepatic drug-metabolizing enzymes within 30 days prior to screening (see Appendix 1)
  • Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplement such as vitamins, calcium supplement within 14 days prior to Screening
  • Use of any investigational drug within 3 months, or the drug withdrawal is less than 6 half-lives (whichever is longer) prior to successful enrollment for dosing
  • Medical history and surgery history:
  • Any history of clinically serious disease, or presence of illness/condition that the investigator considers would affect the study results, including but not limited to the diseases of circulatory system, respiratory system, endocrine system, nervous system, digestive system, urinary system or history of blood, immune, mental and metabolic diseases
  • History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade ventricular tachycardia, ventricular tachycardia, AV block, QT prolongation syndrome, or QT prolongation symptoms and family history, indicated by genetic evidence or sudden death of a close relative due to cardiac conditions at a young age
  • Major surgery history or surgical incision does not completely heal within 6 months prior to the screening; Major surgery includes, but is not limited to, any subject with significant bleeding risk, prolonged general anesthesia, incision of a biopsy or significant traumatic injury
  • Allergic constitution, such as a known history of allergies to two or more substances; or may be allergic to the investigational product or its excipients based on the investigator's judgment
  • Suffering haemorrhoids or perianal disease with blood in the stool or regularly, irritable bowel syndrome, inflammatory bowel disease
  • Life style:
  • Subjects have habitual constipation or diarrhoea
  • Subjects are alcoholism, or frequent alcohol consumption within six months prior to screening, which means drinking more than 14 units of alcohol every week (one unit alcohol equals 360 mL of beer, 45 mL of 40% alcohol or 150 mL of wine); or the alcohol breath test result is ≥20 mg/dl in screening
  • Subjects have smoked more than 5 cigarettes per day in three months before screening, or habitual use of nicotine products, and who can not quit smoking during the study
  • Abusing drug, using soft drugs such as marijuana three months prior to screening, or using hard drugs such as cocaine, amphetamine, phencyclidine, etc. one year prior to screening; or urine test for drugs is positive at screening
  • Subjects have habitual drinking of grapefruit juice, excessive tea, coffee and/or caffeinated beverages, and who can not be abstained during the study
  • Others:
  • Subjects who have to work in radioactive conditions in long time, participated in radio-labeled drug clinical study or had significant radioactive exposure within one year before the study, no less than 2 times of chest/abdominal CT, or no less than 3 times of different types of X-ray exam
  • Subjects with a history of fear of needles, hemophobia, difficulty in blood collection or inability to tolerate venipuncture blood collection;
  • Subjects who plan to have children or donate sperm during the study period and within 1 year after completion of the study, or those who disagree to take strict contraceptive measures during the study or within 1 year after completion of the study for themselves or their spouses (see Appendix 3 for details)
  • Subjects who received any vaccine within 4 weeks before screening, or plan to receive the vaccine during the study
  • Subjects, who have had blood loss/donation up to 400 mL within 3 months, or received blood transfusion within 1 month prior to screening
  • Subjects determined by the investigators to be unsuitable for participating in this study for any reasons

Trial locations and contacts

1 site in 1 country.

China1 site

  • Connect Investigative Site

    Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: A Clinical Study to Evaluate Absorption, Metabolism and Excretion of [14C] CBP-307 in Healthy Chinese Male Adult Subjects - Human Mass Balance and Biotransformation Study of [14C] CBP-307

This study will evaluate the absorption,metabolism and excretion of CBP-307 in healthy chinese male subjects.

Being tested
CBP-307

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBP-307Drug

    CBP-307 capsules oral administration

Study groups in NCT05040113
Study groupRoleWhat they receive
CBP-307ExperimentalTake CBP-307orally at 30 min ± 2 min after the start of high-fat breakfast intake
Receives: Drug: CBP-307

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum concentration (Cmax)

    Ratio of total radioactivity in whole blood to that in plasma

    Measured: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose

  2. Cumulative recovery of total radioactivity in urine or/and feces

    Percentage of each metabolite in urine and feces to the administered dose (% of administered dose) or percentage of circulating metabolites in plasma to total exposure AUC (% AUC)

    Measured: -24 to 0 hour predose to Day22

  3. Time to Peak (Tmax)

    Ratio of total radioactivity in whole blood to that in plasma

    Measured: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose

  4. Area under the curve (AUC0-t and AUC0-inf)

    Ratio of total radioactivity in whole blood to that in plasma

    Measured: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose

  5. Elimination half-life (t1/2)

    Ratio of total radioactivity in whole blood to that in plasma

    Measured: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose

  6. Apparent Clearance (CL/F)

    Ratio of total radioactivity in whole blood to that in plasma

    Measured: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose

  7. Apparent Volume of Distribution (Vd/F)

    Ratio of total radioactivity in whole blood to that in plasma

    Measured: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose

  8. Mean Residence Time (MRT)

    Ratio of total radioactivity in whole blood to that in plasma

    Measured: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2021
  2. Study start4 Sep 2021
  3. Primary completion30 Oct 2021
  4. Study completion30 Oct 2021

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05040113
Sponsor's protocol ID
CBP-307CN004
Status last verified
Jan 2022
First submitted
2 Aug 2021
Last updated
5 Apr 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CBP-307 in people with Healthy Adult Subjects, run by Connect Biopharm LLC 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 5 inclusion and 29 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 5 Apr 2022. 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 concentration (Cmax) (time frame: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour 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?

On the ClinicalTrials.gov record for NCT05040113.

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 5 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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