Healthy Volunteers Clinical Trial
Official title:
A Three-part, Randomized Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BC 007 in Healthy, Young Subjects and Elderly Subjects
Berlin Cures develops BC 007 to treat patients suffering from diseases (chronic heart
failure, pulmonary hypertension, chronic fatigue syndrome etc.) which are associated with
functional autoantibodies (AAB) directed against G-protein coupled receptors (GPCR).
The first part of the study (part A) is designed to evaluate the safety and tolerability of
ascending doses of BC 007. The study part is blinded and placebo controlled in order to
better discriminate possible safety signals. The assessment of safety and tolerability in an
elderly cohort is a bridge to dosing elderly GPCR AAB positive subjects in part B. The
subjects in part A are confirmed to be GPCR AAB negative.
The objective of the second part of the study (part B) is to evaluate the efficacy of BC 007
in neutralizing AAB against GPCR shortly after dosing compared to baseline and to find the
optimal dose for the neutralization of the AAB in all individuals. This dose shall be taken
to progress into a Phase II/III trial with beta1-adrenergic receptor-AAB positive patients
suffering from chronic heart failure.
Part A
Primary objective is:
- To assess safety and tolerability of BC 007 after a single ascending intravenous (i.v.)
bolus + infusion in healthy, young and elderly subjects.
Secondary objectives are:
- To determine the pharmacokinetic plasma and urine profiles of BC 007 in healthy, young
and elderly subjects.
Part B
Primary objective is:
- To assess the neutralizing potency of BC 007 against GPCR autoantibodies alpha -1
adrenergic receptor, beta-1 adrenergic receptor, beta-2 adrenergic receptor or
endothelin-A-receptor following ascending i.v. bolus + infusion.
Secondary objectives are:
- To assess safety and tolerability of BC 007 after a single ascending i.v. bolus +
infusion in GPCR AAB (α(1)-adrenergic receptor AAB, ß(1)-adrenergic receptor AAB,
ß(2)-adrenergic receptor AAB or endothelin-A-receptor AAB) positive healthy elderly
subjects.
- To determine the pharmacokinetic plasma and urine profiles of BC 007 in GPCR AAB
(α(1)-adrenergic receptor AAB, ß(1)-adrenergic receptor AAB, ß(2)-adrenergic receptor
AAB or endothelin-A-receptor AAB) positive healthy elderly subjects.
Part C
Primary Objective
- To assess the neutralizing potency of BC 007 against GPCR autoantibodies alpha-1
adrenergic receptor (α(1)-AR AAB), beta-1 adrenergic receptor (ß(1)-AR AAB), beta-2
adrenergic receptor (ß(2)-AR AAB) or endothelin-A-receptor (ETA AAB) following ascending
i.v. bolus + infusion.
Secondary Objectives
- To assess safety and tolerability of BC 007 after a single ascending i.v. bolus +
infusion in GPCR AAB (α(1)-AR AAB, ß(1)-AR AAB, ß(2)-AR AAB or ETA AAB) positive healthy
elderly subjects.
- To determine the pharmacokinetic plasma and urine profiles of BC 007 in GPCR AAB
(α(1)-AR AAB, ß(1)-AR AAB, ß(2)-AR AAB or ETA AAB) positive healthy elderly subjects.
Explorative Objective
- To investigate the pharmacokinetic plasma and urine profiles of BC 007 metabolites in
GPCR AAB (α(1)-AR AAB, ß(1)-AR AAB, ß(2)-AR AAB or ETA AAB) positive healthy elderly
subjects
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