Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics and pharmacodynamics of monoclonal antibody TB31F in healthy malaria-naïve adults in the Netherlands
- Conditions
- malariaPlasmodium falciparum10037072
- Registration Number
- NL-OMON50099
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
* 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
quiz.
* 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
health at time of mAb administration.
* Subject agrees to their general practitioner (GP) being informed about
participation in the study and agrees to sign a form to request the release by
their GP, and medical specialist when necessary, of any relevant medical
information concerning possible contra-indications for participation in the
study to the investigator(s).
* The subject agrees to refrain from blood donation to Sanquin or for other
purposes throughout the study period according to current Sanquin guidelines.
* Female subjects of non-childbearing potential may be enrolled in the study.
All subjects must agree to use continuous adequate contraception until 2 months
after completion of the study.
(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
guidelines).
o Fever * 38.0°C (100.4°F).
o Any abnormal and clinically significant baseline laboratory screening tests
(appendix 1).
* History of malignancy of any organ system (other than localized basal cell
carcinoma of the skin), treated or untreated, within the past 5 years.
* Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other
immune modifying drugs within three months prior to study onset (inhaled and
topical corticosteroids and oral anti-histamines exempted) or expected use of
such during the study period.
* Positive urine toxicology test for cannabis, cocaine or amphetamines at
screening or at inclusion.
* Screening tests positive for Human Immunodeficiency Virus (HIV), active
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV).
* Use of any investigational or non-registered product (drug or vaccine) during
the study period other than the study product.
* Participation in any other clinical study in the 30 days prior to the start
of the study or during the study period.
* History of adverse reactions to monoclonal antibodies
* Prior receipt of an investigational antimalarial monoclonal antibody.
* Administration of immunoglobulins and/or any blood products within the three
months preceding the first dose of study mAb or planned administration during
the study period.
* Any history of malaria, positive serology for P. falciparum, or previous
participation in any malaria (vaccine) study or CHMI.
* Body weight > 115 kg
* Being an employee or student of the department of Medical Microbiology or
Medium Care of the Radboudumc.
* History of drug or alcohol abuse interfering with normal function in the
period of one year prior to study onset.
* Any other condition or situation that would, in the opinion of the
investigator, place the subject at an unacceptable risk of injury or render the
subject unable to meet the requirements of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>(protocol section 8.1.1)<br /><br>- Number and severity of solicited local adverse events of all severities from<br /><br>first product administration through day 7;<br /><br>- Number and severity of solicited general AEs from first product<br /><br>administration through day 28;<br /><br>- Number and severity of unsolicited adverse events from first product<br /><br>administration through end of study;<br /><br>- Number and severity of serious adverse events from first product<br /><br>administration through end of study. </p><br>
- Secondary Outcome Measures
Name Time Method <p>(protocol section 8.1.1)<br /><br>- TB31F serum concentration at each dose level through end of study;<br /><br>- Percentage of transmission reducing activity at different time points by<br /><br>SMFA. </p><br>