Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal … (NCT06413108) | Clinical Trial Compass
CompletedPhase 1/2
Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Mali
Mali167 participantsStarted 2024-07-12
Plain-language summary
Mali faces a significant challenge with malaria, particularly among its younger population. While existing measures like seasonal chemoprevention and vaccination have shown efficacy, further innovations are necessary to combat this disease. The monoclonal antibody TB31F shows promise in reducing the transmission of malaria. This clinical trial will evaluate the safety and efficacy of the monoclonal antibody TB31F.
Who can participate
Age range10 Years – 50 Years
SexALL
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Inclusion criteria
✓. Written/signed informed consent
✓. Adult cohorts: 18-50 years of age
✓. School-age children cohorts: 10-15 years of age
✓. Haemoglobin ≥10 g/dL
✓. Non-lactating females of childbearing potential agree to the use of continuous adequate contraception for 28 days after having received investigational product
✓. Subject agrees to refrain from blood donation during the study and for 5 months after having received investigational product
✓. Subjects are available to attend all study visits
✓. In opinion of the investigator, the subject can and will comply with the requirements of the protocol
Exclusion criteria
✕. Women who are pregnant (tested at baseline and at day 28 after administration of investigational product by urine and/or serum pregnancy testing (β-hCG)) or lactating
✕. Symptomatic malaria
✕. Current acute or chronic disease, including clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by history or physical examination
✕. Clinically significant abnormal blood chemistries and haematology
✕
What they're measuring
1
Occurrence of at least possibly related solicited local and systemic adverse events
Timeframe: within 7 days of monoclonal antibody TB31F administration
2
Occurrence of at least possibly related unsolicited adverse events
Timeframe: within 28 days of monoclonal antibody TB31F administration
3
Occurrence of at least possibly related serious adverse events
Timeframe: from enrollment to the end of follow-up at 28 or 84 days
4
Terminal serum half-life (t½) of monoclonal antibody TB31F in serum
Timeframe: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
5
Maximum observed serum concentration (Cmax) of monoclonal antibody TB31F in serum
Timeframe: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
6
Time to reach maximum serum concentration (tmax) of monoclonal antibody TB31F in serum
Timeframe: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
7
Accumulation index (Racc) of monoclonal antibody TB31F in serum
Timeframe: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 year
✕. History of adverse reactions to monoclonal antibodies
✕. Administration of immunoglobulin and/or blood products within the three months preceding the first dose of the investigational product or planned administration during the study period
✕. 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
8
Area under the serum concentration-time curve (AUC0-Ï„, AUC0-t and AUC) of monoclonal antibody TB31F in serum
Timeframe: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
9
Within-group percent reduction in the proportion of mosquitoes infected at day 5 post-treatment compared to baseline (day 0), assessed through direct membrane feeding assays and measured as oocyst prevalence