A Phase 1 Study of of VVZ-149 Injections in Healthy Male Volunteers

Not Applicable

Completed

• Conditions: Not Applicable

• Registration Number: KCT0009038
• Lead Sponsor: Vivozon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-09-19
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 4

Inclusion Criteria

1. Subjects who agree to participate in the study voluntarily and write the sign on informed consent
2. Healthy male subjects aged from 40 to 70 years old
3. Subjects who have the body weight from 55 kg to 80 kg and BMI ranged between 20.0 and 27.0 kg/m2
4. Subjects who are deemed healthy at the screening for this study (medical history, prior medication, physical examinations, vital signs, ECG, and clinical Laboratories evaluations)

Exclusion Criteria

1. Subjects with history or current of any clinical significant illness in liver (including viral hepatitis infection etc.), kidney, nervous system, respiratory system, endocrine system, and immune system, or in blood/neoplastic disease, cardiovascular disease, venereal disease(syphilis), psychiatry (depression, mood disorders, obessive-compulsive disorder, schizophrenia etc).
2. Clinically significant ECG findings as determined by the investigator at the screening visit: Prolonged QRS > 200 msec or QTcF > 450 msec.
3. Subjects who have done whole blood donation or blood component transfusion within 30 days before screening visit and the first administration of study drug
4. Subjects who have done with spinal fluid or CSF collection within 30days from screening visit
5. Subjects who show hypersensitivity or allergic reaction to local anesthetic such as lidocaine
6. Subjects who have the history of lumbar or back pain or any related disease, and lumber or back injury history, or have the medical history restricting lumbar puncher procesure such as lumbar scoliosis or dystrophic change etc.
7. Subjects who hold CNS related disease such as brain lesions, epilepsy, brain tumor etc.
8. Subjects with a history of bleeding or coagulation of blood, or low platelet counts (<130x10^9/L), or increased INR (>1.3) at screening visit
9. Subjects who are taking hemodilution agents such as antiplatelet drugs (aspirin etc) or anticoagulant drugs (warfarin etc) at screening visit
10. History of alcohol, opiate, or other drug abuse or dependence within 12 months prior to the screening visit
11. Subjects with a history of drug abuse or who show the positive resutls from respiratory alcohol test and urine drug abuse test
12. Use of drugs that are known to increase the PR and QRS interval (Appendix A) within 24 hours prior to study drug injection
13. Use of weak/moderate/strong CYP3A inhibitors and inducers or the drugs that are known as clinical substrates of renal transporters OCT2 and MATE1/2K (Appendix B) within 24 hours prior to study drug injection
14. Subject who cannot commit sexual abstinence from screening till the completion day of the study, or who cannot comply to the medically acceptable contraceptive guidance, or who is planning to donate sperms within 100 days after the study completion
*Infertile subjects or subjects who agrees to use of the medically acceptable contraceptive methods can participate the study; Use of condom, oral contraception of partners or spouses for more than 3 months, injectible or insertible contraceptive method, or intra-uterine device
15. Subjects who have participated in another clinical trial and have taken IP within 6 months before the first date of VVZ-149 treatment
16. Subjects who are judged to be ineligible for the participation in the clinical trial by Investigator due to any other reasons

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified