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The randomized, double-blind, placebo-controlled anddose escalation I phase study evaluating the tolerence, pharmacokenetics andefficacy of single dose andescalating dose to target dose every week of CJC-1134- PC in healthy subjects

The randomized, double-blind, placebo-controlled anddose escalation I phase study evaluating the tolerence, pharmacokenetics andefficacy of single dose andescalating dose to target dose every week of CJC-1134- PC in healthy subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPC-15007191
Enrollment
Unknown
Registered
2015-10-05
Start date
2015-10-16
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

2.0,3.0,4.0mg:CJC-1134-PC

Sponsors

The first hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy male between 18 and45 years of age, body weight >=50kg; 2. Body Mass Index (BMI) between 19-24kg/m2 with similar weight; 3. No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening; 4. No birth plan within 6 months after completed the study; 5. Ability to understandandprovide written informed consent andvoluntary consent to participate in the study; 6. Ability to complete the study in compliance with the protocol.

Exclusion criteria

Exclusion criteria: 1. A clinically significant laboratory abnormality or other clinical findings indicative of a clinically significant exclusionary disease (including but not limited to renal, hepatic, gastrointestinal, cardiovascular, neurological disease); 2. A clinically significant ECG abnormality; 3. A positive hepatitis screen including hepatitis B surface antigen (HBsAg) andhepatitis C/HIV antibody; 4. Positive screen of drug andalcohol; 5. No smoking during the study; 6. A history of hypersensitivity to CJC-1134-PC; 7. Has a history of drug and/or alcohol abuse; 8. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 3 months prior to the initial dose of study medication; 9. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication; 10. Use of any prescription drug therapy within 14 days prior to receiving study drug; 11. Use of any Vitamins or herbal products within 14 days prior to receiving study drug; 12. Consumption of alcohol within 24 hours prior to receive study drug; 13. Consumption of any grapefruit or grapefruit-containing juices within 7 days prior to receiving study drug; 14. Consumption of any caffeine-containing foods or beverages within 48 hours prior to receiving study drug; 15. Use of an investigational drug or product, or participation in a drug research study within 3 months prior to receiving study drug; 16. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption; 17. Recent major changes in diet or exercise habits; 18. In the stage of screening or before using research medicine, acute disease occurred; 19. Have active peptic ulcer or bleeding, andalways had recurrent ulcer or bleeding; 20. A positive result of pregnancy test; 21. History of cholelithiasis; 22. History of pancreatitis.

Design outcomes

Primary

MeasureTime frame
blood pressure;

Countries

China

Contacts

Public ContactYanhua Ding
dingyanhua2003@126.com+86 15943049468

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026