Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of DA-302168S Tablets

NCT06534320 | Completed Phase 1

• 1 other identifier: 2023-CP-DA168-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0.

  SAD up to Day 5 and MAD up to Day 9.

Secondary Outcomes (8)

• Peak Plasma Concentration (Cmax)

  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

  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

  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-∞

  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

  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.

Study Arms (2)

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.

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.

Drug: Placebo of DA-302168S

Interventions

DA-302168S DRUG

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.

DA-302168S

Placebo of DA-302168S DRUG

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.

Placebo of DA-302168S

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Chendu DIAO Pharmaceutical Group CO., LTD.: lead

Study Sites (1)

Gulou Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Li, Doctor

  Gulou Hospital Affiliated to Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 2, 2024
• Study Start: April 18, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)