At a glance
ClinicalIndex Comparison Record- ✓Healthy children aged 5 months to 10 years (Part 1) or 5-59 months (Part 2)
- ✓Weight ≥5 kg with specified upper limits by part and dose group (≤30 kg Part 1, ≤22.5 kg Part 2, ≤20 kg for 30 mg/kg group, ≤15 kg for 40 mg/kg group)
- ✓Hemoglobin level ≥8 g/dL
- ✓Height and weight Z-scores >-2
- ✕Current significant medical conditions including neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, renal, oncologic, or hematological disease
- ✕Known sickle cell disease
- ✕HIV infection
- ✕History of severe allergic reaction or anaphylaxis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium Falciparum, in an Age De-Escalation, Dose-Escalation Trial and a Randomized, Placebo-Controlled, Double-Blind Trial of Children in Western Kenya
In Brief
A Phase 2 clinical trial evaluating L9LS and Placebo for Plasmodium Falciparum Infection and Malaria. Completed, enrolled 912 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective efficacy of one or two doses of L9LS against naturally occurring Plasmodium falciparum (Pf) infection among Kenyan children aged 5 to 59 months at enrollment, in a setting of perennial high transmission.
Study Details
Timeline
Interventions
Administered subcutaneously.
Normal saline administered subcutaneously.