Monitor Medikal Arastirma Ve Danismanlik Ticaret Ltd. Sirketi

This is a national, single-center, dose-escalation Phase I study to investigate the safety, pharmacokinetics, and efficacy of a combination containing Ropivacaine, Clonidine, and Betamethasone (Ropiclobet) in healty volunteers.
After screening and eligibility confirmation, at least 28 participants will receive a sciatic nerve block in the popliteal region with Ropiclobet, followed by pharmacokinetic assessments through blood sampling and monitoring of motor and sensory nerve blocks in the tibial and common peroneal nerves. Safety evaluations, including physical exams, vital signs, ECGs, and sedation scores, will be conducted throughout the study. sensory blocks resolve.
Participants will remain under observation for 48 hours post-procedure and will be discharged once motor and sensory blocks resolve. Follow-up visits will be conducted on Days 10 and 15 on an outpatient basis, with an end-of-study visit planned for Day 30.
The dose-escalation protocol involves administering 5 mL, 10 mL, 15 mL, and 20 mL doses to sequential groups of participants, with safety assessments performed after each dose level before proceeding.

The CoVacHGMix adenoviral vector vaccine is a new vaccine developed to protect against SARS-CoV-2 and is a Phase I study designed based on adaptive clinical trial standards. In this Phase I study, it is aimed to test the safety and efficacy of the investigational product at 2 different dose levels (low: 5x1010 and high: 1x1011) in volunteers aged 18-59 years. Vaccination will be performed as two doses: on days 0 and 28. In line with adaptive design standards, Phase I will be transferred to Phase II. In this phase, 2 different dose levels will be tested, and the dose and application forms in Phase II will be determined according to the results of Phase I. One of the aims of the study is to collect sufficient data to determine the final dose and method of administration to be applied in the phase III study and clinic.

This is a randomized, parallel dose assigned, double blind, multi center, Phase II study assessing the efficacy, safety, and immunogenicity of VLP vaccine (Authentic and Alpha variants) in adults between 18 and 59 years who are healthy or have medically stable chronic diseases and who have no known history of SARS-CoV-2 infection