Study design
We conducted a single-center, randomized, Phase 1, single blind,
placebo-controlled clinical trial to evaluate the safety, tolerability,
and PK of INM004 in two stages. In stage I, a single dose was given (at
2 dose levels, 2 mg/kg and 4 mg/kg), and in stage II, 3 daily 4 mg/kg
doses were given. The study enrolled healthy adult volunteers between
December 2017 and September 2018 in a single site in Argentina.
Eligible participants included fourteen healthy volunteers 18-55 years
old, with a body mass index (BMI) of 19-27 kg.m-2, normal laboratory
values, chest ray, and electrocardiogram recordings. Exclusion criteria
included history of equine serum allergy or any history of allergy,
prior administration of equine serum for other indications (anti-tetanus
serum, anti-ophidic serum, anti-arachnid toxin serum, among others),
pregnancy, seropositivity for HIV, hepatitis B or C, mental condition,
drug or alcohol abuse, any history of cardiovascular, hepatic,
pulmonary, gastrointestinal, hematological, or neurological illness,
having taken any prescription drugs within the two weeks before the
inclusion date, infectious disease within 30 days before the inclusion,
or having a personal bond with any of the study personnel.
All study subjects provided written informed consent after receiving
comprehensive information of the objectives, methods, and potential
harms related to their participation in the study. The present study was
approved by the local ethics committee and the Argentine National Food
and Drug Regulatory Agency, Administración Nacional de Medicamentos,
Alimentos y Tecnología Médica (ANMAT). The study was prospectively
registered in clinicaltrials.gov
(NCT03388216).