A Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food on the Pharmacokinetics of DRL-17822 in Healthy Adult Male Volunteers - Study protocol DRL-17822/CD/001

Dr. Reddy's Laboratories Ltd.0 个研究点目标入组 72 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•1.Male subjects, 18-45 years of age, inclusive (Parts I and II), 18-55 years of age, inclusive (Part III);
•2.Body mass index (BMI) >= 18.0 and <= 28.0 kg/m2 (Parts I and II), >= 18.0 and <= 30.0 kg/m2 (Part III);
•3. HDL-C levels <= 1.3 mmol/L at Screening (Part III only);
•4. Informed consent;
•5. Good health, based upon the results of the screening;
•6.Venous access sufficient to allow blood sampling as per protocol;

•1. Positive for hepatitis B, C or HIV;
•2. Positive drug screen result at Screening or on Day -1;
•3. Positive alcohol breath test result at Screening or during admission;
•4. Use of prescription medication within 2 weeks prior to Day 1;
•5. Use of over-the-counter medication (including homeopathic medicines) within 4 days prior to Day 1, excluding routine vitamins and incidental use of paracetamol;
•6. History of clinically significant haematologic, renal, hepatic, cardiovascular, neurologic, endocrinal, oncologic, pulmonary, immunologic, or psychiatric disorders;
•7. History of clinically significant allergies;
•8. Unwilling to comply with contraceptive measures up to 90 days after last dosing;
•9. Presence or history of alcoholism or drug abuse;
•10. Use of more than 21 units of alcohol per week;
•11. Smoking ;
•12. Participation in an investigational drug study within 90 days prior to Day 1;
•13. Loss or donation of >350 mL of blood within 90 days prior to Day 1;
•14. Unsuitable to participate in the study for any reason in the opinion of the PI.

发起方

Dr. Reddy's Laboratories Ltd.