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Healthy SubjectsPhase 1NCT06896760

A Mass Balance Study of [14C]ABSK011

A Phase 1 study testing [14C]ABSK011 in people with Healthy Subjects, run by Abbisko Therapeutics Co, Ltd at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of [14C] ABSK011 in healthy adult male subjects. The study plans to enroll 6 to 8 healthy male subjects to ensure at least 6 evaluable 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 Subjects
What is being tested?
[14C]ABSK011
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
7 Apr 2025to 7 Apr 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Participants who fully understand the content, procedures and possible adverse reactions before the study, and voluntarily sign the informed consent form, and can complete the study in accordance with the requirements in the protocol;
  • Healthy male participants aged 18 to 45 years (including 18 and 45 years) at screening;
  • Weight ≥ 50 kg, body mass index (BMI) between 19 and 26 (including 19 and 26), BMI = weight (kg)/height (m) ^2;
  • Participants must have regular defecation in the past three months;
  • Male participants of childbearing potential must agree to use effective contraceptive methods during the study and within 6 months after administration of study drug . Male subjects must agree to not donate sperm during this period.

Who cannot join

  • Abnormal and clinically significant complete physical examination, vital signs, digital rectal examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, stool routine + occult blood, thyroid function, etc.), 12-lead electrocardiogram, chest X-ray (anteroposterior position), abdominal B ultrasound (hepatobiliary, pancreas, spleen and kidney);
  • Tested positive for any one of the following: serum hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, treponema pallidum antibody (Syphilis) screening;
  • The baseline of heart rate corrected QT, QTcF interval prolongs ≥450ms; family history of long QT syndrome (Note: QTc interval is corrected by Fridericia formula);
  • Known or persistent mental disorders that may interfere with the subject's participation in the study, as judged by the investigator;
  • Known history of allergy to any drug or food;
  • Participants who have participated in drug trials within 3 months before dosing.
Show all 9Show fewer
  • Participants who have participated in this study or any other study related to ABSK011, and have previously exposed to ABSK011;
  • Known history of drug abuse or tested positive in drug abuse screening;
  • Participants with any other factors that may influence the participation in the study, which may affect the subject's compliance with the protocol, interfere with the interpretation of the study results, or expose the subject to risk, as judged by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yuan LU, Doctor contact

13700000000

clinical@abbisko.cn

China1 site

  • Beijing GoBroad Hospital

    Beijing, Beijing Municipality, 102206

    Quankun Zhuang, Doctor

    Quankun Zhuang, Doctor

Other trials in China

About this study

Official title: A Mass Balance Study of [14C]ABSK011 in Healthy Adult Male Chinese Participants

This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of [14C] ABSK011 in healthy adult male subjects. The study plans to enroll 6 to 8 healthy male subjects to ensure at least 6 evaluable subjects.

Read the detailed description

Participants will be screened no more than 14 days before the dose (D-14 through D-3) and admitted to the clinical trial unit 2 days before the dose (D-2). Participants will receive a single oral administration of approximately 200 mg/120 µCi [14C]ABSK-011 suspension after a low-fat breakfast on day 1 morning.

Urine and stool samples will be collected from participants before and at specified intervals between 0 and 192 hours after taking the drug and blood samples will be collected at specified time points between 0 and 120 hours before and after taking the drug.

Being tested
[14C]ABSK011

What participants receive

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

  • [14C]ABSK011Drug

    The standard meal was taken the night before administration, and the patient was fasted for at least 10 h without drinking water overnight. The next morning, eat a low-fat meal, finish the meal within 30 minutes, and take the test drug with warm water 30 minutes (±5 minutes) after the beginning of the meal. The total volume of warm water and suspension liquid is about 240 mL. Except for meals and administration, no water was allowed 1 hour before and 1 hour after medication. No food is allowed for 4 hours after taking the medication. Throughout the study, participants received meals provided by the center at approximately the same time each day.

Study groups in NCT06896760
Study groupRoleWhat they receive
[14C]ABSK011ExperimentalParticipants will receive a single oral administration of approximately 200 mg/120 µCi [14C]ABSK-011 suspension after a low-fat breakfast on day 1 morning.
Receives: Drug: [14C]ABSK011

What is being measured

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

  1. Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)

    To assess the routes and rates of elimination of ABSK011 and its metabolites after single oral administration of [14C]ABSK011 in healthy adult male subjects

    Measured: All excreted urine and feces samples at specified time points during 0-192 hours after dosing will be collected.

  2. Percentage of each metabolite in urine and feces relative to the administered dose (% administered dose), or percentage of metabolites in plasma relative to total exposure AUC (% AUC);

    To determine the metabolism and elimination pathways of ABSK011 after single oral administration of [14C] ABSK011 in healthy adult male subjects, and identify major metabolites.All excreted urine and feces samples at specified time points during 0-192 hours after dosing will be collected.

    Measured: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol

  3. %AUC

    To evaluate the pharmacokinetics of ABSK011 and its major metabolites in the urine of healthy adult male subjects after a single oral administration [14C] of ABSK011.

    Measured: Conduct testing within 1 month after all subjects collect all samples at all time points required by the protocol

Secondary outcomes (1)

  1. Frequency, type and severity of adverse events/serious adverse events; changes in vital signs, 12-lead ECGs, laboratory tests, etc.

    To assess the safety and tolerability of a single oral dose of approximately [14C] ABSK011 in healthy adult male subjects

    Measured: From signing the ICF until 9 days after the first dosing

Timeline

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

  1. First posted26 Mar 2025
  2. Study start7 Apr 2025 (estimated)
  3. Primary completion7 Nov 2025 (estimated)
  4. Study completion7 Apr 2026 (estimated)

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06896760
Sponsor's protocol ID
ABSK-011-103
Status last verified
Mar 2025
First submitted
20 Mar 2025
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]ABSK011 in people with Healthy Subjects, run by Abbisko Therapeutics 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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 26 Mar 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuan LU, Doctor (13700000000, clinical@abbisko.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces) (time frame: All excreted urine and feces samples at specified time points during 0-192 hours after dosing will be collected.). The study lists 3 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 NCT06896760.

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 26 Mar 2025.

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