Pharmacokinetics of mistletoe lectin in healthy volunteers after intravenous infusion of Helixor® P

Pharmacokinetics of mistletoe lectin in healthy volunteers after intravenous infusion of Helixor® P - HePPI-730-169-2021

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027485

Enrollment

Registered

2022-05-23

Start date

2022-06-14

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

not applicable because healthy subjects

Interventions

Group 1: Helixor® P, single intravenous infusion of 2000 mg

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: • Legal capacity • Ability to understand the nature, scope and importance of the clinical trial and to follow the instructions of the investigator • Gender: male • Age = 18 years and = 45 years • non-smokers • Body mass index 18.5 - 28 kg / m2 • Standard values for blood pressure, pulse, body temperature • Standard values for haematological, biochemical and coagulation parameters • Standard-compliant EKG • Existence of a personally signed and dated declaration of consent after verbal and written information about the benefits and risks of the clinical trial

Exclusion criteria

Exclusion criteria: • Signs of clinically significant disease • Regular use of medication • Positive urine screening for drugs • A positive blood test for alcohol • Known drug allergy • Any allergic disease other than the investigator considers irrelevant for the purposes of this study • Positive HIV, hepatitis B or C serology • Medication or drug abuse or risky alcohol consumption (see chapter 6.1.1 for definition) • Donating blood within the last 3 months before starting the study • Difficult peripheral vein access • Mistletoe pretreatment in any form, including oral intake of food supplements containing mistletoe, phytopharmaceuticals or teas • Participation in another clinical trial • Subjects who are dependent on or employed by the sponsor or trial center

Design outcomes

Primary

Measure	Time frame
Recording of the pharmacokinetics of mistletoe lectin in the blood serum of healthy subjects during and after a single intravenous infusion of 2,000 mg Helixor® P over a period of 72 hours after the end of administration	—

Secondary

Measure	Time frame
Recording of the safety and tolerability of Helixor® P during and after a single intravenous infusion of 2,000 mg over a period of up to 12 ± 3 days after the end of the administration	—

Countries

Germany

Contacts

Public ContactRoman Huber

Uni-Zentrum Naturheilkunde Universitätsklinikum Freiburg

roman.huber@uniklinik-freiburg.de+49 761 2708 2010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026