A60
Conditions
Interventions
Group 1: HDIT101, 50mg single-dose i.v.
Group 2: HDIT101, 150mg single-dose i.v.
Group 3: HDIT101, 450mg single-dose i.v.
Group 4: HDIT101, 1350mg single-dose i.v.
Group 5: HDIT101, 4050mg single-dose
Sponsors
Heidelberg ImmunoTherapeutics GmbH c/o NCT
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Check at screening and at Day 1 (up to 72 h before dosing) (1) Ability to provide written, personally signed and dated informed consent to participate in the trial. (2) Understanding, ability, and willingness to fully comply with trial interventions and restrictions. (3) Healthy male or female volunteer = 18 years and = 60 years at the time of informed consent. (4) Adequate access to the peripheral venous system allowing the insertion of two peripheral venous cannulas (1x left arm, 1x right arm) and repetitive sampling of blood samples. (5) Body mass index of = 18 and = 30 kg/m². (6) Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory evaluation (hematology, biochemistry, coagulation, and urinalysis) as assessed by a physician who is a member of the trial team. (7) Adequate liver, renal, and bone marrow function as defined by a. ASAT and ALAT = 1.3 upper limit of the normal (ULN). b. Alkaline phosphatase and gGT = 1.5 ULN. c. Total bilirubin = 1.3 ULN, except in case of suspected Gilbert’s disease: non-fasting total bilirubin = 1.3 ULN and fasting total bilirubin = 2.0 ULN is acceptable. d. Estimated glomerular filtration rate (eGFR) calculated with the Cockcroft & Gault formula = 60 mL/min. e. Hemoglobin = 12.0 g/dL for male participants and = 11.0 g/dL for female participants. f. Platelets = 140 / nL. g. White blood cell count (WBC) = 3.5 / nL (participants with a WBC = 3.0 / nL and < 3.5 / nL may be included after consultation with a hematologist). (8) Adequate cardiovascular function defined by a. Resting systolic blood pressure = 100 mmHg and < 140 mmHg. b. Resting diastolic blood pressure = 50 mmHg and < 90 mmHg. c. Resting heart rate = 50 beats per minute (bpm) and = 100 bpm. d. No clinically relevant findings in the ECG. (9) Women of childbearing potential1 (WCBP) must have a negative ß-HCG urine or blood test within 72 h before receiving treatment. (10) WCBP and men with partners of childbearing potential are only included if they confirm to remain sexually inactive, have a sterilized partner, or to use reliable contraception with a Pearl Index < 1 % (i.e. two independent effective contraceptive methods: combined hormonal contraception associated with inhibition of ovulation [oral, intravaginal, or transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, or implantable], intrauterine device, or intrauterine hormone-releasing system) during the trial and for 12 weeks after the administration of trial medication.
Exclusion criteria
Exclusion criteria: Check at screening and at Day 1 (up to 72 h before dosing) (1) Active HSV infection (i.e. visible HSV lesion on skin or mucosa) (2) Current or relevant history of physical or psychiatric illness with a risk of relapse as judged by the investigator, any medical disorder that may require treatment or make the participant unlikely to fully complete the trial, or any condition that presents undue risk from the HDIT101 administration or trial interventions. (3) Any condition that precludes the sampling of max. 350 mL of blood over the duration of the trial. (4) Participants must refrain from blood / plasma donation up to 12 weeks after dosing of HDIT101. (5) Use of any prescription medication (except contraceptive pills, iodine, or thyroid hormones) within 14 d prior to administration of the IMP. (6) Male participants who consume more than 21 units (1 unit = 8 g alcohol) of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day. (7) A positive result in drug OR alcohol test at screening. (8) A positive HIV antibody screen, hepatitis B virus (HBV) infection screen, OR hepatitis C virus (HCV) antibody screen. (9) Any known allergies to drugs or any history of severe allergic or anaphylactic reactions OR any other clinically significant allergies (mild forms of hay fever are acceptable, if currently asymptomatic without treatment). (10) Active enrollment in another clinical drug trial or last administration of study drug in a clinical drug trial within the last 30 d or within 5 half-lives of the previous drug(s), whichever is longer. (11) Prior vaccination with a HSV type 1/2 vaccine (e.g. experimental). (12) Pregnant or breast-feeding women. (13) Any other medical condition that would, in the opinion of the Investigator, limit participant ability to complete the trial. (14) Known intolerance to the active substance or excipients of the IMP. (15) Previous participation in this trial unless screening failure Additional check at Day 1 (16) A positive result in drug OR alcohol test at Day 1. (17) History of vaccination within 30 d prior to dosing of the IMP. (18) Use of any non-prescription medication or over-the-counter (OTC) medicine (including herbal preparations) with pharmacologically active ingredients within 14 d prior to the dosing of HDIT101. (19) Consumption of any alcohol-containing products within 24 h prior to Day 1 and throughout the duration of the participant's stay in the Clinical Research Unit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the trial is the number of participants experiencing a DLT (dose-limiting toxicity) during the 48-h observation period up to Visit 3 on Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence rate, severity, and relatedness to HDIT101 of AEs, and serious adverse drug events (SAE). AEs may be identified by physical examination, laboratory parameters, vital signs, or ECG. - Non-compartmental PK characteristics of HDIT101 and population pharmacokinetic modeling of PK data if deemed necessary - Anti-drug antibodies (ADA) in blood. 48h post dose (cut-off DLT period) | — |
Countries
Germany
Contacts
Public ContactWalter E. Haefeli
Klinisch-Pharmakologisches Studienzentrum
Outcome results
None listed