NL-OMON50099
Completed
Not Applicable
Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics and pharmacodynamics of monoclonal antibody TB31F in healthy malaria-naïve adults in the Netherlands - Safety, tolerability, and pharmacokinetics and pharmacodynamics of TB31F
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Subject must sign written informed consent to participate in the trial.
- •\* Subject is able to understand planned study procedures and demonstrate
- •comprehension of the protocol procedures and knowledge of study by passing a
- •\* In the opinion of the investigator, the subject can and will comply with the
- •requirements of the protocol.
- •\* Subjects are available to attend all study visits and are reachable by phone
- •throughout the entire study period from day \-1 until day 84 (end of study).
- •\* The subject will remain within reasonable travelling distance from the study
- •center from day \-1 till day \+7 after mAb TB31F administration.
- •\* Subject is a male or non\-pregnant female age \* 18 and \* 35 years and in good
Exclusion Criteria
- •(Protocol section 4\.3\.)
- •\* Acute or chronic disease at time of TB31F administration, clinically
- •significant pulmonary, cardiovascular, hepatic or renal functional abnormality,
- •as determined by physical examination or laboratory screening tests:
- •o Acute disease is defined as the presence of a moderate or severe illness with
- •or without fever. Subjects with a minor illness on the day of TB31F
- •administration will be temporarily excluded from participation, but may be
- •re\-evaluated for inclusion at a later date. Subjects with a positive SARS\-CoV2
- •test at inclusion will be (temporarily) excluded from participation but may be
- •re\-evaluated for inclusion at a later date (following current Radboudumc
Outcomes
Primary Outcomes
Not specified
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