Clinical trial NCT05569720: First in Human Study to Compare Safety Between Intravenous Bolus Versus Infusion of ApTOLL
Official title: First in Human Clinical Trial to Compare Safety and Tolerability Between Intravenous Infusions and Bolus Intravenous Inhection of ApTOLL in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Lead sponsor: aptaTargets S.L.
Sponsor class: INDUSTRY
Collaborators: name: Centro para el Desarrollo Tecnológico Industrial
First posted: 2022-10-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to assess the tolerability and safety of ApTOLL administration when comparing intravenous infusion vs. bolus intravenous injection, in healthy volunteers. Pharmacokinetic profile of ApTOLL will be also analysed as secondary objective of the study.


Eligibility criteria: Inclusion Criteria:

* Male or female (with no possibility to become pregnant (hysterectomized or menopausal women)) subjects who give their written consent to participate in the study.
* Aged from 18 to 55.
* No clinically significant organic or psychic conditions.
* No clinically significant abnormalities in medical records and physical examination.
* No clinically significant abnormalities in haematology, coagulation, biochemistry, serology and urinalysis .
* No clinically significant abnormalities in vital signs and electrocardiogram.

Exclusion Criteria:

* Subjects affected by an organic or psychic condition.
* Subjects who have received prescribed pharmacological treatment in the last 15 days or any kind of medication in the 48 hours prior to receiving the study medication
* Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.
* History of sensitivity to any drug.
* Positive drug screening (for cannabis, opiates, cocaine and amphetamines).
* Smoker.
* Daily consumers of alcohol and/or acute alcohol poisoning in the last week.
* Having donated blood in the last month before start of the study.
* Participation in another study with administration of investigational drugs in the previous 3 months (if the study was conducted with drug substances marketed in Spain, a period of at least 1 month or 5 half lives, what is longer, will be considered).
* Inability to follow the instructions or collaborate during the study.

Primary outcomes:
measure: Adverse Events
timeFrame: day 1 to day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clinical Pharmacology Department. Hospital Universitario de La Princesa
Study officials:
affiliation: aptaTargets S.L.
name: Macarena Hernández, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario La Princesa
name: Dolores Ochoa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hernandez-Jimenez M, Martin-Vilchez S, Ochoa D, Mejia-Abril G, Roman M, Camargo-Mamani P, Luquero-Bueno S, Jilma B, Moro MA, Fernandez G, Pineiro D, Ribo M, Gonzalez VM, Lizasoain I, Abad-Santos F. First-in-human phase I clinical trial of a TLR4-binding DNA aptamer, ApTOLL: Safety and pharmacokinetics in healthy volunteers. Mol Ther Nucleic Acids. 2022 Mar 9;28:124-135. doi: 10.1016/j.omtn.2022.03.005. eCollection 2022 Jun 14.
citation: Fernandez G, Moraga A, Cuartero MI, Garcia-Culebras A, Pena-Martinez C, Pradillo JM, Hernandez-Jimenez M, Sacristan S, Ayuso MI, Gonzalo-Gobernado R, Fernandez-Lopez D, Martin ME, Moro MA, Gonzalez VM, Lizasoain I. TLR4-Binding DNA Aptamers Show a Protective Effect against Acute Stroke in Animal Models. Mol Ther. 2018 Aug 1;26(8):2047-2059. doi: 10.1016/j.ymthe.2018.05.019. Epub 2018 Jun 15.