Overweight and ObesityPhase 1DA168NCT06534320
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of DA-302168S Tablets
A Phase 1 study testing DA-302168S in people with Overweight and Obesity, run by Chendu DIAO Pharmaceutical Group CO., LTD. at 1 site in China.
Trial summary
To Evaluate the Safety, Tolerability and Pharmacokinetics on DA-302168S Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase I Clinical Trials in Healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- DA-302168S
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2024to 31 Dec 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 55 years old (including 18 and 55 years old), male or female.
- Weight: male ≥50kg, female ≥45kg, body mass index (BMI) in the range of 19.0 ~ 28.0kg/m2 (including the end value).
- Subjects and their spouses or partners did not plan to become pregnant or plan to donate sperm or ovum during the study period until 3 months after the last dose, and agreed to use at least one acceptable and effective contraceptive method.
- No clinically significant abnormalities identified in the judgement of investigator at screening.
- Written informed consent prior to any study specific procedures.
Who cannot join
- subjects with a history of abnormal clinical presentation, diseases to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, endocrine system, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systems, and a history of malignant tumors, which are judged to be clinically significant by the Investigator.
- Use of any medication (including prescription, over-the-counter, herbal, etc.) or nutraceutical within 14 days prior to the first dose.
- May have any contraindications, allergies or hypersensitivity to DA-302168S Tablets (both test drug and placebo) or its excipients, GLP-1RA, DPP-4 analogues.
- Previous family history of medullary thyroid carcinoma or type 2 multiple endocrine adenoma syndrome.
- History or evidence of any of the following conditions:
- Decompensated heart failure (New York Heart Association (NYHA) Cardiac Classification III and IV [Appendix 5: NYHA Heart Failure Classification]), cardiac arrhythmias (e.g., supraventricular tachycardia, atrial fibrillation, atrial flutter, second or third degree atrioventricular block, QTcF intervals > 450 milliseconds for men or > 470 milliseconds for women [Appendix 8: Fridericia Method Corrected QT Interval Formula], PR intervals > 220 milliseconds, etc.) prior to the first administration of the study drug. (e.g., supraventricular tachycardia, atrial fibrillation, atrial flutter, grade II or III AV block, QTcF interval >450 ms in males or >470 ms in females [Appendix 8: Formula for Correcting QT Intervals by the Fridericia Method], PR interval >220 ms, etc.) and who, in the opinion of the investigator, are unsuitable for participation in this study;
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- Serious trauma or acute infection that may affect glycemic control within 4 weeks prior to screening;
- Positive results for any of the Hepatitis B Surface Antigen, Hepatitis C Antibody, Syphilis Spirochete Antibody, or Human Immunodeficiency Virus (HIV) Antibody;
- Mental or neurological illness prior to screening, unwillingness to communicate, or a language barrier that prevents full understanding and cooperation;
- Other medical or psychiatric conditions that may increase the risk of participation in the study or that, in the judgment of the Investigator, may make the subject unsuitable for participation in the study, including a recent history (within the past two years) of major depression or other serious mental disorder, or any history of attempted suicide.
- Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg prior to the first dose and who, in the opinion of the investigator, are not suitable for participation in the study.
- Those who screen positive for substance abuse or have a history of substance abuse within the past five years or have used drugs in the 3 months prior to screening.
- Those who have participated in a clinical trial of another drug within 3 months prior to screening and have received any of the clinical trial drugs.
- Elective surgery was planned during the study period.
- Those who have donated or lost ≥200mL of blood, received a blood transfusion, or used blood products within 3 months prior to screening.
- Female subjects are pregnant or lactating.
- Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day, or who consumed tea, coffee and/or caffeinated beverages within 48 hours prior to the first dose of the drug, or who were unable to discontinue consumption during the trial period
- Previous chronic intake of xanthine- or grapefruit-rich beverages or foods, or consumption of any xanthine- or grapefruit-rich product within 48 hours prior to the first dose.
- Smokers or those who smoked an average of ≥5 cigarettes per day in the 3 months prior to screening, or those who were unable to stop using any tobacco-based products during the trial.
- Heavy drinkers or regular drinkers in the 3 months prior to screening, i.e., those who consume more than 14 standardized units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol by volume spirits or 150 mL of wine) or those who have a positive breath test for alcohol at baseline or who are unable to discontinue the use of any alcohol-containing product during the test period.
Trial locations and contacts
1 site in 1 country.
China1 site
Gulou Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210008
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effects of Food in Single/Multiple Oral Administration of DA-302168S Tablets
To Evaluate the Safety, Tolerability and Pharmacokinetics on DA-302168S Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase I Clinical Trials in Healthy Subjects.
- Conditions
- Overweight and Obesity
- Being tested
- DA-302168S, Placebo of DA-302168S
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-302168SDrug
SAD study may cotain 7 cohorts at dosage of 2.5 mg, 7.5 mg, 15 mg, 30 mg, 50 mg, 75 mg, 100 mg. Each cohort enrolls 6 subjects receive DA-302168S tablets.
Placebo of DA-302168SDrug
SAD study may cotain 7 cohorts at dosage of 2.5 mg, 7.5 mg, 15 mg, 30 mg, 50 mg, 75 mg, 100 mg. Each cohort enrolls 2 subjects receive placebo of DA-302168S tablets.
DA-302168SDrug
MAD study may cotain 1-4 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 8 subjects receive study DA-302168S tablets.
Placebo of DA-302168SDrug
MAD study may cotain 1-4 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 2 subjects receive study placebo of DA-302168S tablets.
| Study group | Role | What they receive |
|---|---|---|
| DA-302168S | Experimental | This study includes single-dose ascending and multiple-dose ascending studies. SAD study may contain 7 dose groups of 2.5 mg, 7.5 mg, 15 mg, 30mg, 50mg, 75mg and 100 mg. MAD study contains 1-4 dose groups which were evaluated in SAD study to be tolerated. Receives: Drug: DA-302168S |
| Placebo of DA-302168S | Placebo comparator | This study includes single-dose ascending and multiple-dose ascending studies. SAD study may contain 7 dose groups of 2.5 mg, 7.5 mg, 15 mg, 30mg, 50mg, 75mg and 100 mg. MAD study contains 1-4 dose groups which were evaluated in SAD study to be tolerated. Receives: Drug: Placebo of DA-302168S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0.
Measured: SAD up to Day 5 and MAD up to Day 9.
Secondary outcomes (8)
Peak Plasma Concentration (Cmax)
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
Tmax
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
AUC0-t
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
AUC0-∞
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
t1/2
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
CL/F
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
Vd/F
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
Kel
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start18 Apr 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Li, Doctor, Principal investigator, Gulou Hospital Affiliated to Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534320
- Sponsor's protocol ID
- 2023-CP-DA168-01
- Acronym
- DA168
- Status last verified
- Dec 2024
- First submitted
- 26 Jul 2024
- Last updated
- 15 Apr 2025
- 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effects of Food in Single/Multiple Oral Administration of DA-302168S Tablets
- ClinicalTrials.gov ID
- NCT06534320
- Acronym / sponsor ID
- DA168 / 2023-CP-DA168-01
- Conditions
- Overweight and Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Aug 2024 (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.
To Evaluate the Safety, Tolerability and Pharmacokinetics on DA-302168S Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase I Clinical Trials in Healthy Subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-302168S | Experimental | Drug: DA-302168SThis study includes single-dose ascending and multiple-dose ascending studies. SAD study may contain 7 dose groups of 2.5 mg, 7.5 mg, 15 mg, 30mg, 50mg, 75mg and 100 mg. MAD study contains 1-4 dose groups which were evaluated in SAD study to be tolerated. |
| Placebo of DA-302168S | Placebo comparator | Drug: Placebo of DA-302168SThis study includes single-dose ascending and multiple-dose ascending studies. SAD study may contain 7 dose groups of 2.5 mg, 7.5 mg, 15 mg, 30mg, 50mg, 75mg and 100 mg. MAD study contains 1-4 dose groups which were evaluated in SAD study to be tolerated. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 55 years old (including 18 and 55 years old), male or female.
- Weight: male ≥50kg, female ≥45kg, body mass index (BMI) in the range of 19.0 ~ 28.0kg/m2 (including the end value).
- Subjects and their spouses or partners did not plan to become pregnant or plan to donate sperm or ovum during the study period until 3 months after the last dose, and agreed to use at least one acceptable and effective contraceptive method.
- No clinically significant abnormalities identified in the judgement of investigator at screening.
- Written informed consent prior to any study specific procedures.
Key exclusion criteria (20 listed)
- subjects with a history of abnormal clinical presentation, diseases to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, endocrine system, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systems, and a history of malignant tumors, which are judged to be clinically significant by the Investigator.
- Use of any medication (including prescription, over-the-counter, herbal, etc.) or nutraceutical within 14 days prior to the first dose.
- May have any contraindications, allergies or hypersensitivity to DA-302168S Tablets (both test drug and placebo) or its excipients, GLP-1RA, DPP-4 analogues.
- Previous family history of medullary thyroid carcinoma or type 2 multiple endocrine adenoma syndrome.
- History or evidence of any of the following conditions:
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 |
|---|---|---|
| DA-302168SSAD study may cotain 7 cohorts at dosage of 2.5 mg, 7.5 mg, 15 mg, 30 mg, 50 mg, 75 mg, 100 mg. Each cohort enrolls 6 subjects receive DA-302168S tablets. | Drug | DA-302168S |
| Placebo of DA-302168SSAD study may cotain 7 cohorts at dosage of 2.5 mg, 7.5 mg, 15 mg, 30 mg, 50 mg, 75 mg, 100 mg. Each cohort enrolls 2 subjects receive placebo of DA-302168S tablets. | Drug | Placebo of DA-302168S |
| DA-302168SMAD study may cotain 1-4 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 8 subjects receive study DA-302168S tablets. | Drug | DA-302168S |
| Placebo of DA-302168SMAD study may cotain 1-4 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 2 subjects receive study placebo of DA-302168S tablets. | Drug | Placebo of DA-302168S |
Primary outcome
Safety and Tolerability
Time frame: SAD up to Day 5 and MAD up to Day 9.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0.
8 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
Tmax
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
AUC0-t
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
AUC0-∞
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
t1/2
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
CL/F
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
Vd/F
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
Kel
Time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose in SAD phase. MAD study will be adjusted according to the SAD study.
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 15 Apr 2025.
- 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.
Juan Li, Doctor principal investigator
Gulou Hospital Affiliated to Nanjing Medical 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 DA-302168S in people with Overweight and Obesity, run by Chendu DIAO Pharmaceutical Group 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 20 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 15 Apr 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. Some participants in this study may receive a placebo. 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?
Safety and Tolerability (time frame: SAD up to Day 5 and MAD up to Day 9.). 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 Apr 2025.