Healthy Adult SubjectsPhase 1NCT07857265
Mass Balance Study of [14C]DA-302168S in Healthy Chinese Adult Male Participants
A Phase 1 study testing [14C] DA-302168S in people with Healthy Adult Subjects, run by Chendu DIAO Pharmaceutical Group CO., LTD..
Trial summary
In this study, a single dose of [14C] radiolabelled DA-302168S will be administered orally. The main purpose of this study is to find out how much of DA-302168S and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral [14C] DA-302168S. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- [14C] DA-302168S
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2026to 20 Dec 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants aged 18-55 years inclusive at ICF signing.
- At screening, weight ≥50.0 kg and BMI 19.0-28.0 kg/m² inclusive.
- Male participants must agree to use reliable contraception for themselves and their partners during the study and for 1 year after dosing (see Appendix 2), and not donate sperm for assisted reproduction.
- Able to understand the study procedures and methods, voluntarily sign the ICF, and willing to strictly comply with the protocol and complete the study.
- Detailed medical history, physical examination, vital signs, laboratory tests [CBC, blood chemistry, coagulation, urinalysis, stool routine and occult blood, thyroid function (FT3, FT4, TSH), HbA1c, amylase, lipase, serum calcitonin], 12-lead ECG, chest X-ray (PA), digital rectal examination, and abdominal ultrasound (liver, gallbladder, pancreas, spleen, both kidneys) show no abnormalities or no clinically significant abnormalities.
Who cannot join
- History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or MEN2; or serum calcitonin ≥50 ng/L at screening.
- History of chronic pancreatitis, or acute pancreatitis within 3 months before ICF signing.
- History of acute gallbladder disease within 3 months before ICF signing.
- Any malignancy within 5 years before ICF signing (except basal cell carcinoma treated with curative therapy and considered cured).
- History of serious cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, or endocrine disease within 1 year before ICF signing (e.g., acute myocardial infarction, major depression, gastric ulcer, uremia).
- As judged by the investigator, dysphagia at screening, or concurrent conditions that may affect drug absorption, distribution, metabolism, or excretion, such as active inflammatory bowel disease, gastrectomy, or any intestinal resection.
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- Severe hypoglycemia within 3 months before screening.
- History of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis), or known intolerance or allergy to GLP-1R agonists.
- Hemorrhoids, or perianal disease with regular/current hematochezia, irritable bowel syndrome, or inflammatory bowel disease.
- Habitual constipation or diarrhea.
- Blood donation or major bleeding (≥400 mL) within 3 months before screening, or between screening and first dose.
- History of drug abuse within 3 years before screening (e.g., morphine, ketamine, THC acid, methamphetamine, MDA, cocaine), or positive urine drug test at screening (D-2).
- Smoking >5 cigarettes/day or habitual use of nicotine-containing products within 3 months before screening, and unable to abstain during the study.
- History of alcohol abuse within 1 year before screening (male: >14 standard units/week; 1 unit = 14 g alcohol, e.g., 360 mL beer, 45 mL 40% spirits, or 150 mL wine), or positive alcohol breath/blood test at screening.
- Special dietary requirements and unable to accept the standardized diet.
- Habitual intake of grapefruit juice or excessive tea, coffee, and/or caffeinated beverages (>8 cups, 1 cup = 250 mL) within 3 months before screening, and unable to abstain during the study.
- Unable to avoid strenuous exercise or other behaviors that may affect PK parameters from 48 h before dosing through the entire study.
- History of needle or blood phobia, difficult blood collection, or intolerance to venipuncture.
- Use of any medication within 28 days or 5 elimination half-lives before first dose, whichever is longer, including prescription drugs, OTC drugs, herbal medicines, Chinese patent medicines, or nutritional supplements.
- Live vaccination within 1 month before screening, or planned vaccination during the study.
- Participation in any clinical trial within 3 months before screening (except ICF signing only without drug/device intervention), or last dose of investigational drug <5 half-lives before screening.
- Occupational long-term radiation exposure; or significant radiation exposure within 1 year before the study (e.g., ≥2 chest/abdominal CT scans or ≥3 other types of X-ray examinations); or planned radiological diagnosis/treatment within 1 year after the study; or participation in a clinical trial involving radiolabeled drugs within 1 year.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study on the Mass Balance of [14C]DA-302168S in Healthy Adult Male Trial Participants in China
In this study, a single dose of [14C] radiolabelled DA-302168S will be administered orally. The main purpose of this study is to find out how much of DA-302168S and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral [14C] DA-302168S.
- Conditions
- Healthy Adult Subjects
- Being tested
- [14C] DA-302168S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] DA-302168SDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| [14C] DA-302168S | Experimental | A single dose of [14C] DA-302168S administered orally. Receives: Drug: [14C] DA-302168S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total recovery of DA-302168S radioactivity in urine and feces, following oral administration of [14C] DA-302168S
Measured: Predose up to Day 8 after administration of [14C]DA-302168S
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start20 Nov 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857265
- Sponsor's protocol ID
- 2026-CP-DA168-12
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Mass Balance of [14C]DA-302168S in Healthy Adult Male Trial Participants in China
- ClinicalTrials.gov ID
- NCT07857265
- Acronym / sponsor ID
- 2026-CP-DA168-12
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 5 Oct 2026 (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.
In this study, a single dose of [14C] radiolabelled DA-302168S will be administered orally. The main purpose of this study is to find out how much of DA-302168S and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral [14C] DA-302168S.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] DA-302168S | Experimental | Drug: [14C] DA-302168SA single dose of [14C] DA-302168S administered orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male participants aged 18-55 years inclusive at ICF signing.
- At screening, weight ≥50.0 kg and BMI 19.0-28.0 kg/m² inclusive.
- Male participants must agree to use reliable contraception for themselves and their partners during the study and for 1 year after dosing (see Appendix 2), and not donate sperm for assisted reproduction.
- Able to understand the study procedures and methods, voluntarily sign the ICF, and willing to strictly comply with the protocol and complete the study.
- Detailed medical history, physical examination, vital signs, laboratory tests [CBC, blood chemistry, coagulation, urinalysis, stool routine and occult blood, thyroid function (FT3, FT4, TSH), HbA1c, amylase, lipase, serum calcitonin], 12-lead ECG, chest X-ray (PA), digital rectal examination, and abdominal ultrasound (liver, gallbladder, pancreas, spleen, both kidneys) show no abnormalities or no clinically significant abnormalities.
Key exclusion criteria (23 listed)
- History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or MEN2; or serum calcitonin ≥50 ng/L at screening.
- History of chronic pancreatitis, or acute pancreatitis within 3 months before ICF signing.
- History of acute gallbladder disease within 3 months before ICF signing.
- Any malignancy within 5 years before ICF signing (except basal cell carcinoma treated with curative therapy and considered cured).
- History of serious cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, or endocrine disease within 1 year before ICF signing (e.g., acute myocardial infarction, major depression, gastric ulcer, uremia).
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] DA-302168SAdministered orally | Drug | [14C] DA-302168S |
Primary outcome
Total recovery of DA-302168S radioactivity in urine and feces, following oral administration of [14C] DA-302168S
Time frame: Predose up to Day 8 after administration of [14C]DA-302168S
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C] DA-302168S in people with Healthy Adult Subjects, run by Chendu DIAO Pharmaceutical Group CO., LTD..
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 23 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 qin xiaolong (18781997925, qinxiaolong.cn@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total recovery of DA-302168S radioactivity in urine and feces, following oral administration of [14C] DA-302168S (time frame: Predose up to Day 8 after administration of [14C]DA-302168S). 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 15 Oct 2026.