Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT05407779

Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 in Healthy Volunteers

Healthy Clinical Trial

Official title:
An Open-Label, Non-controlled Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 (JSC BIOCAD, Russia) in Healthy Volunteers

Clinical Trial Summary

The aim of the study is to investigate the pharmacodynamics, pharmacokinetics, safety, and immunogenicity of BCD-180 after a single intravenous administration in escalating doses to healthy volunteers.

Clinical Trial Description

The study will be carried out in 2 stages. Stage 1 involves administration of escalating doses of study drug (BCD-180) in 7 cohorts of healthy subjects. The first cohort will include one subject ("sentinel volunteer"). Each of the subsequent cohorts will include 3 subjects, each of whom will receive a preset cohort dose of BCD-180 as a single intravenous infusion. Stage 2: additionally two cohorts of healthy Asian volunteers (Cohorts 8 and 9) will be included: subjects will receive a single infusion of BCD-180 at selected doses (planned for further clinical development) based on the results of the main period of Stage 1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05407779
Study type Interventional
Source Biocad
Contact
Status Completed
Phase Phase 1
Start date January 22, 2021
Completion date September 30, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1