Malaria,FalciparumPhase 1/2NCT06413108
Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Mali
A Phase 1/2 study testing TB31F and Normal saline in people with Malaria,Falciparum, run by Radboud University Medical Center at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- TB31F and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 1 siteMali
- Study dates
- 12 Jul 2024to 16 Jan 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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
- Written/signed informed consent
- 10-50 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
- Asymptomatic P. falciparum mono-infection with asexual parasite densities <3000 parasites/µL
- Presence of P. falciparum gametocytes on thick blood film at a density >16 gametocytes/µL
Who cannot join
- 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
- 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
Show all 20Show fewer
- 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
- EFFICACY COHORT (STUDY ARM 6)
- 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
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years
- 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
- Use of anti-malarial drug treatment in the last 14 days
- Prior receipt of an antimalarial monoclonal antibody
- Prior receipt of a P. falciparum transmission-blocking vaccine
Trial locations and contacts
1 site in 1 country.
Mali1 site
Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Sciences Techniques and Technologies of Bamako
Bamako, Point G, BP1805
About this study
Official title: A Phase 1/2a Single Centre, Randomised, Placebo-controlled, Double-blind, Dose-escalation, Age De-escalation, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Malaria-exposed Malian Adults and Children
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.
- Conditions
- Malaria,Falciparum
- Being tested
- TB31F, Normal saline
- Keywords
- transmission-reducing, monoclonal antibody
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB31FDrug
transmission-blocking monoclonal antibody TB31F
Normal salineOther
normal saline as control (placebo)
| Study group | Role | What they receive |
|---|---|---|
| 1A: control | Placebo comparator | 0.2 mL normal saline Receives: Other: Normal saline |
| 1B: 10 mg TB31F | Experimental | 0.2 mL (10 mg) TB31F Receives: Drug: TB31F |
| 2A: control | Placebo comparator | 2 mL normal saline Receives: Other: Normal saline |
| 2B:100 mg TB31F | Experimental | 2 mL (100 mg) TB31F Receives: Drug: TB31F |
| 3A: control | Placebo comparator | 4 mL normal saline Receives: Other: Normal saline |
| 3B: 200 mg TB31F | Experimental | 4 mL (200 mg) TB31F Receives: Drug: TB31F |
| 4A: control | Placebo comparator | 0.2 mL normal saline Receives: Other: Normal saline |
| 4B: 10 mg TB31F | Experimental | 0.2 mL (10 mg) TB31F Receives: Drug: TB31F |
| 5A: control | Placebo comparator | 2.0 mL normal saline Receives: Other: Normal saline |
| 5B: 100 mg TB31F | Experimental | 2.0 mL (100 mg) TB31F Receives: Drug: TB31F |
| 6A: control | Placebo comparator | 0.6 or 2.0 mL normal saline Receives: Other: Normal saline |
| 6B: 30 mg TB31F | Experimental | 0.6 mL (30 mg) TB31F Receives: Drug: TB31F |
| 6C: 100 mg TB31F | Experimental | 2.0 mL (100 mg) TB31F Receives: Drug: TB31F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of at least possibly related solicited local and systemic adverse events
Measured: within 7 days of monoclonal antibody TB31F administration
Occurrence of at least possibly related unsolicited adverse events
Measured: within 28 days of monoclonal antibody TB31F administration
Occurrence of at least possibly related serious adverse events
Measured: from enrollment to the end of follow-up at 28 or 84 days
Terminal serum half-life (t½) of monoclonal antibody TB31F in serum
Measured: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Maximum observed serum concentration (Cmax) of monoclonal antibody TB31F in serum
Measured: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Time to reach maximum serum concentration (tmax) of monoclonal antibody TB31F in serum
Measured: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Accumulation index (Racc) of monoclonal antibody TB31F in serum
Measured: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Area under the serum concentration-time curve (AUC0-τ, AUC0-t and AUC) of monoclonal antibody TB31F in serum
Measured: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
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
Measured: day 0 [baseline] & 5
Secondary outcomes (9)
Within-group percent reduction in the proportion of mosquitoes infected in direct skin feeding assay (DSF), compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Measured: day 0 [baseline], 1, and 5
Within-group percent reduction in the proportion of mosquitoes infected in direct membrane feeding assays (DMFA), compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Measured: day 0 [baseline], 1, 5, and 14
Mosquito infection prevalence, assessed by direct skin feed and measured as the proportion dissected mosquitoes with any number of oocysts, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Measured: day 0 [baseline], 1, and 5
Mosquito infection prevalence, assessed by DMFA and measured as the proportion dissected with any number of oocysts, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Measured: day 0 [baseline], 1, 5, and 14
Mosquito infection intensity, assessed by direct skin feed and measured as the number of oocysts in dissected mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Measured: day 0 [baseline], 1, and 5
Mosquito infection intensity, assessed by DMFA and measured as the average number of oocysts in dissected mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Measured: day 0 [baseline], 1, 5, and 14
Participant infection prevalence, assessed by DSF as the proportion of individuals infectious to any number of mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Measured: day 0 [baseline], 1, and 5
Participant infection prevalence, assessed by DMFA as the proportion of individuals infectious to any number of mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Measured: day 0 [baseline], 1, 5, and 14
Transmission-reducing activity in school-age children and adults, measured as the percent reduction in mean oocyst intensity compared to experimental controls, compared within groups and between groups at all feeding timepoints.
Measured: day 0 [baseline], 5, 14, 28, 56, and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start12 Jul 2024
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria,FalciparumStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- We will perform two sequential stages of clinical research, each recruiting a distinct cohort of participants to confirm: 1. TB31F safety and 2. TB31F efficacy. The safety cohort will be composed of the three dose groups in adults (groups 1, 2 and 3) and two dose groups in children (groups 4 and 5). The efficacy cohort will be composed of two dose groups in adults and children (group 6). Participants will be randomised within each treatment group to receive a single sub-cutaneous dose of TB31F or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Malaria Research and Training Center, Bamako, Mali, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413108
- Sponsor's protocol ID
- TB31F Mali
- Status last verified
- Sep 2025
- First submitted
- 3 May 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Single Centre, Randomised, Placebo-controlled, Double-blind, Dose-escalation, Age De-escalation, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Malaria-exposed Malian Adults and Children
- ClinicalTrials.gov ID
- NCT06413108
- Acronym / sponsor ID
- TB31F Mali
- Conditions
- Malaria,Falciparum
- Keywords
- transmission-reducing, monoclonal antibody
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Malaria Research and Training Center, Bamako, Mali, London School of Hygiene and Tropical Medicine
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
- Model description
- We will perform two sequential stages of clinical research, each recruiting a distinct cohort of participants to confirm: 1. TB31F safety and 2. TB31F efficacy. The safety cohort will be composed of the three dose groups in adults (groups 1, 2 and 3) and two dose groups in children (groups 4 and 5). The efficacy cohort will be composed of two dose groups in adults and children (group 6). Participants will be randomised within each treatment group to receive a single sub-cutaneous dose of TB31F or placebo.
| Arm | Type | Receives |
|---|---|---|
| 1A: control | Placebo comparator | Other: Normal saline0.2 mL normal saline |
| 1B: 10 mg TB31F | Experimental | Drug: TB31F0.2 mL (10 mg) TB31F |
| 2A: control | Placebo comparator | Other: Normal saline2 mL normal saline |
| 2B:100 mg TB31F | Experimental | Drug: TB31F2 mL (100 mg) TB31F |
| 3A: control | Placebo comparator | Other: Normal saline4 mL normal saline |
| 3B: 200 mg TB31F | Experimental | Drug: TB31F4 mL (200 mg) TB31F |
| 4A: control | Placebo comparator | Other: Normal saline0.2 mL normal saline |
| 4B: 10 mg TB31F | Experimental | Drug: TB31F0.2 mL (10 mg) TB31F |
| 5A: control | Placebo comparator | Other: Normal saline2.0 mL normal saline |
| 5B: 100 mg TB31F | Experimental | Drug: TB31F2.0 mL (100 mg) TB31F |
| 6A: control | Placebo comparator | Other: Normal saline0.6 or 2.0 mL normal saline |
| 6B: 30 mg TB31F | Experimental | Drug: TB31F0.6 mL (30 mg) TB31F |
| 6C: 100 mg TB31F | Experimental | Drug: TB31F2.0 mL (100 mg) TB31F |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (20 listed)
- 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
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB31Ftransmission-blocking monoclonal antibody TB31F | Drug | 1B: 10 mg TB31F, 2B:100 mg TB31F, 3B: 200 mg TB31F, 4B: 10 mg TB31F, 5B: 100 mg TB31F, 6B: 30 mg TB31F, 6C: 100 mg TB31F |
| Normal salinenormal saline as control (placebo) | Other | 1A: control, 2A: control, 3A: control, 4A: control, 5A: control, 6A: control |
Primary outcome
Occurrence of at least possibly related solicited local and systemic adverse events
Time frame: within 7 days of monoclonal antibody TB31F administration
Occurrence of at least possibly related unsolicited adverse events
Time frame: within 28 days of monoclonal antibody TB31F administration
Occurrence of at least possibly related serious adverse events
Time frame: from enrollment to the end of follow-up at 28 or 84 days
Terminal serum half-life (t½) of monoclonal antibody TB31F in serum
Time frame: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Maximum observed serum concentration (Cmax) of monoclonal antibody TB31F in serum
Time frame: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Time to reach maximum serum concentration (tmax) of monoclonal antibody TB31F in serum
Time frame: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Accumulation index (Racc) of monoclonal antibody TB31F in serum
Time frame: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
Area under the serum concentration-time curve (AUC0-τ, AUC0-t and AUC) of monoclonal antibody TB31F in serum
Time frame: day 0 [baseline], day 1, day 5, day 7, day 14, day 21, day 28, day 42, day 56, day 84.
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
Time frame: day 0 [baseline] & 5
9 secondary outcomes
Within-group percent reduction in the proportion of mosquitoes infected in direct skin feeding assay (DSF), compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, and 5
Within-group percent reduction in the proportion of mosquitoes infected in direct membrane feeding assays (DMFA), compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, 5, and 14
Mosquito infection prevalence, assessed by direct skin feed and measured as the proportion dissected mosquitoes with any number of oocysts, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, and 5
Mosquito infection prevalence, assessed by DMFA and measured as the proportion dissected with any number of oocysts, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, 5, and 14
Mosquito infection intensity, assessed by direct skin feed and measured as the number of oocysts in dissected mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, and 5
Mosquito infection intensity, assessed by DMFA and measured as the average number of oocysts in dissected mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, 5, and 14
Participant infection prevalence, assessed by DSF as the proportion of individuals infectious to any number of mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, and 5
Participant infection prevalence, assessed by DMFA as the proportion of individuals infectious to any number of mosquitoes, compared within groups between baseline and all feeding time points, and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 1, 5, and 14
Transmission-reducing activity in school-age children and adults, measured as the percent reduction in mean oocyst intensity compared to experimental controls, compared within groups and between groups at all feeding timepoints.
Time frame: day 0 [baseline], 5, 14, 28, 56, and 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TB31F and Normal saline in people with Malaria,Falciparum, run by Radboud University Medical Center at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of at least possibly related solicited local and systemic adverse events (time frame: within 7 days of monoclonal antibody TB31F administration). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.