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Angiotensin I (1-7)

APN01, a physiological formulation of recombinant human Angiotensin Converting Enzyme 2 administrated i.v.

APN01

Placebo

Stephan Kraehenbuehl, Prof. Dr.

The purpose of this study is to define the dose for a Phase II study and to investigate safety and tolerability of intravenous administration of recombinant soluble human Angiotensin Converting Enzyme 2 in healthy volunteers.

APN01-1-01 is a placebo controlled double blinded Phase I study composed of a single dose, dose escalation part followed by a multiple dosage part. The first four cohorts (four individuals each) will receive 100, 200, 400 and 800 µg/kg APN01 i.v. or placebo. Cohorts 5 and 6 (three individuals each) will receive three and six i.v. APN01 administrations daily, respectively. Planned dosage of the multiple dose part will be 400 µg/kg.

Safety and Tolerability Study of APN01 (Recombinant Human Angiotensin Converting Enzyme 2)

Double-blind, Placebo-controlled Dose-escalation Phase I Study With Recombinant Human Soluble Angiotensin Converting Enzyme 2 (rhACE2) APN01 in Healthy Volunteers

Apeiron Biologics

Prof. Dr. Krähenbühl, Chefarzt klinische Pharmakologie & Toxikologie

Infections

Symptoms and General Pathology

Rare Diseases

COVID-19

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

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Chronic Graft Versus Host Disease

Hematinics

Antibodies

Vaccines

Immunoglobulins

Liver Extracts

Hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease,Chronic Liver Diseases, Cancer diseases Patients

the antibody titer and adverse reactions were observed.

SARS-COV-2 VACCINE

DACHUAN M CAI, PH D

DAZHI M ZHANG, PH D

Hong Ren, PH D

On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19).Due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), COVID-19 's severe illness and mortality mainly increase in these special population. Vaccination of COVID-19 vaccine can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality.To evaluate the safety and effectiveness of the population vaccinated with COVID-19 vaccine, and to play a scientific and theoretical supporting role in guiding COVID-19 vaccination scientifically, reasonably and effectively, so this study was carried out.

Due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), COVID-19 's severe illness and mortality mainly increase in these special population. At present, there is no evidence that these special population have been vaccinated against COVID-19, but CDC vaccination and the guidelines and consensus of various professional societies hold that: (1) the people with underlying diseases have low immunity and are easy to develop into severe patients with high mortality; (2) although there is no direct evidence of evidence-based medicine, it is best to be vaccinated with COVID-19 vaccine in the absence of disease progression activities to reduce high risk. To evaluate the safety and effectiveness of the population vaccinated with COVID-19 vaccine, and to play a scientific and theoretical supporting role in guiding COVID-19 vaccination scientifically, reasonably and effectively, so this study was carried out.

Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease

Evaluate the safety of the vaccine by observing the occurrence of adverse events(such as fever, dizziness, nausea, headache，fatigue, myalgia, etc) and recording the number of subjects with adverse events.

The titer and duration of COVID-19 antibody were produced at 15 days, 30 days, 90 days, 180 days after vaccination, so as to clarify whether the level of immune response to COVID-19 vaccine was affected in people with basic disease.

After the entire vaccination process was completed, blood was drawn and samples were collected at four nodes 15 days, 30 days, 90 days, and 180 days for the levels of B cells and related subgroups、Treg and CTL.

The Second Affiliated Hospital of Chongqing Medical University

Dr/ Prof.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Tolerability Study of APN01 (Recombinant Human Angiotensin Converting Enzyme 2)	NCT00886353	Pulmonary Disea... Cardiovascular ... Kidney Diseases Cancer Diseases	APN01 Placebo	18 Years -	Apeiron Biologics
Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease	NCT05043246	Diseases, Chron... Covid19 Adverse Reactio...	SARS-COV-2 VACC...	18 Years - 80 Years	The Second Affiliated Hospital of Chongqing Medical University
Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease	NCT05043246	Diseases, Chron... Covid19 Adverse Reactio...	SARS-COV-2 VACC...	18 Years - 80 Years	The Second Affiliated Hospital of Chongqing Medical University

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