Topics

Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects

2020-03-31 04:04:34 | BioPortfolio

Summary

This is a study to assess the safety and blood levels of study drug KAE609 given in the vein. The study consists of two parts:

- Part A is a single ascending dose (SAD) study with 4 cohorts of 8 subjects each, where participants will receive 1 dose of KAE609 or placebo (contains no medicine).

- Part B is a multiple-ascending dose (MAD) study with 2 cohorts of 9 subjects each, where participants will receive 5 doses of KAE609 or placebo.

A review of the safety and pharmacokinetic data will be conducted at the completion of each cohort prior to dosing of the next subsequent cohort.

Study Design

Conditions

Malaria

Intervention

KAE609, Placebo

Status

Not yet recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-03-31T04:04:34-0400

Clinical Trials [599 Associated Clinical Trials listed on BioPortfolio]

Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses. This study aims to determine the maximum safe dose of the i...

Effectiveness of KAE609 in Reducing Asexual & Sexual Blood-stage P.Falciparum Infection & Infectivity to Mosquitos

This is a single-center open label study conducted in multiple sequential cohorts using Induced Blood Stage Malaria infection in healthy volunteers to characterize the effectiveness of KAE...

Malaria Prevalence in Children

The purpose of this pilot study is to evaluate the use of (1) 'malaria prevalence', (2) 'malaria incidence' and (3) 'malaria mortality' as a measure of malaria transmission in The Gambia, ...

Controlled Human Malaria Infection in Semi-Immune Kenyan Adults. (CHMI-SIKA)

We wish to understand how resistance to malaria develops and how this affects the growth rate of malaria in individuals who have past exposure to malaria.

Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ) Extension Study

A double-blind, individual randomised trial will be undertaken in children under five years of age living in areas of Burkina Faso or Mali where the transmission of malaria is intense and ...

PubMed Articles [1193 Associated PubMed Articles listed on BioPortfolio]

Impact of malaria in pregnancy on risk of malaria in young children: systematic review and meta-analyses.

Our objective was to quantify the risk of acquiring malaria among progeny of women with malaria during pregnancy.

Critical Roles of Endogenous Glucocorticoids for Disease Tolerance in Malaria.

During malaria, the hypothalamic-pituitary-adrenal (HPA) axis is activated and glucocorticoid (GC) levels are increased, but their essential roles have been largely overlooked. GCs are decisive for sy...

PRIMVAC vaccine adjuvanted with Alhydrogel or GLA-SE to prevent placental malaria: a first-in-human, randomised, double-blind, placebo-controlled study.

PRIMVAC is a VAR2CSA-derived placental malaria vaccine candidate aiming to prevent serious clinical outcomes of Plasmodium falciparum infection during pregnancy. We assessed the safety and immunogenic...

Display of malaria transmission-blocking antigens on chimeric duck hepatitis B virus-derived virus-like particles produced in Hansenula polymorpha.

Malaria caused by Plasmodium falciparum is one of the major threats to human health globally. Despite huge efforts in malaria control and eradication, highly effective vaccines are urgently needed, in...

Determining the cutoff of rainfall for Plasmodium falciparum malaria outbreaks in India.

Malaria outbreaks due to Plasmodium falciparum have been reported from various parts of India. Rainfall is considered as one of the major determinants for malaria outbreaks, however, an estimate of ra...

Medical and Biotech [MESH] Definitions

Malaria caused by PLASMODIUM VIVAX. This form of malaria is less severe than MALARIA, FALCIPARUM, but there is a higher probability for relapses to occur. Febrile paroxysms often occur every other day.

Vaccines made from antigens arising from any of the four strains of Plasmodium which cause malaria in humans, or from P. berghei which causes malaria in rodents.

A protozoan parasite that causes vivax malaria (MALARIA, VIVAX). This species is found almost everywhere malaria is endemic and is the only one that has a range extending into the temperate regions.

Malaria caused by PLASMODIUM FALCIPARUM. This is the severest form of malaria and is associated with the highest levels of parasites in the blood. This disease is characterized by irregularly recurring febrile paroxysms that in extreme cases occur with acute cerebral, renal, or gastrointestinal manifestations.

A protozoan parasite that occurs naturally in the macaque. It is similar to PLASMODIUM VIVAX and produces a type of malaria similar to vivax malaria (MALARIA, VIVAX). This species has been found to give rise to both natural and experimental human infections.

More From BioPortfolio on "Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects"

Quick Search

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...


Searches Linking to this Trial