The goal of this clinical trial is to evaluate the safety and tolerability of single and multiple doses of IMP761 in healthy female and male volunteers aged 18-55 with no history of disease affecting the immune system or recent use of medication with effects on the immune system. The main question it aims to answer is: \- if IMP761 is safe and tolerable as determined by assessing vital signs, emerging (serious) adverse events, electrocardiography, and clinical laboratory tests. Researchers will compare IMP761 to a placebo (a look-alike substance that contains no drug) to see if single and multiple doses of IMP761 are safe and tolerable in healthy volunteers. Part B of the study also investigates the effect of IMP761 on the inhibition of the keyhole limpet haemocyanin (KLH) driven immune response compared with placebo. Participants will: * receive IMP761 or a matching placebo intravenously once in single dose (part A and B) and three times in multiple dose (part C) during a 4 day in clinic stay with 4-8 following visits. * receive KLH challenge * be monitored for up to 103 days after the first dose.
This is a first in human, randomized, prospective, single centre, double blind, placebo-controlled study in healthy volunteers. It consists of three separate parts (Part A, B and C) with different study designs. The main objective is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose (SAD) (Part A and B) and multiple ascending doses (MAD) (Part C) of IMP761 as assessed by: * Vital signs * Treatment-emergent (serious) adverse events ((S)AEs) * Electrocardiography. * Clinical laboratory tests * Laser speckle contrast imaging (LSCI) * Multispectral skin imaging Part A: SAD study in healthy subjects (cohort 1, 5 subjects) Cohort 1: 5 subjects, single i.v. dose of IMP761 or placebo (3:2). The first 2 subjects will receive IMP761 or placebo (1:1) as sentinel dosing, while the following 3 subjects will receive IMP761 or placebo (2:1). Part B: SAD study in healthy subjects, KLH challenge (cohort 2-8, 60 subjects) Cohort 2-3: 5 subjects, single i.v. dose of IMP761or placebo (4:1). Cohort 4-8: 10 subjects, single i.v. dose of IMP761 or placebo (8:2). Part C: MAD study in healthy subjects (MAD cohort 1-2, 14 subjects) MAD Cohort 1-2: 7 subjects, multiple (three i.v. doses of IMP761 or placebo (5:2). Investigational Medicinal Product (IMP)/placebo administration every 28 days; dose selection to be based on observed pharmacodynamic effects in part B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
79
CHDR
Leiden, Netherlands
RECRUITINGOccurrence of clinically relevant abnormalities in vital signs
Time frame: From screening to the follow up visit after last treatment (up to 143 days)
Frequency of adverse events (AEs)
Time frame: From administration to the follow up visit after last treatment (up to 103 days)
Duration of adverse events (AEs)
Time frame: From administration to the follow up visit after last treatment (up to 103 days)
Severity of adverse events (AEs)
Time frame: From administration to the follow up visit after last treatment (up to 103 days)
Occurrence of clinically relevant abnormalities in electrocardiography
Time frame: From screening to the follow up visit after last treatment (up to 143 days)
Occurrence of clinically relevant abnormalities in safety laboratory assessments
Time frame: From screening to the follow up visit after last treatment (up to 143 days)
Pharmacokinetic (PK) parameter: Maximum Serum Concentration (Cmax) (Part B and C)
Time frame: Up to 86 days
PK parameter: Timepoint of Maximum Serum Concentration (tmax) (Part B and C)
Time frame: Up to 86 days
PK parameter: Minimum Serum concentration (Cmin) (Part B and C)
Time frame: Up to 86 days
PK parameter: Area Under the Curve (AUC) (Part B and C)
Time frame: Up to 86 days
PK parameter: systemic clearance (CL) (Part B and C)
Time frame: Up to 86 days
PK parameter: Apparent volume of distribution at steady state (Vss) (Part B and C)
Time frame: Up to 86 days
PK parameter: Apparent volume of distribution at terminal state (Vz) (Part B and C)
Time frame: Up to 86 days
PK parameter: elimination half-life (t1/2) (Part B and C)
Time frame: Up to 86 days
PK Parameter: Trough Concentration (Ctrough ) (Part C)
Time frame: Up to 86 days
PK Parameter: Peak to trough ratio (PTR) (Part C)
Time frame: Up to 86 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.