First in Human Study to Compare Safety Between Intravenous Bolus Versus Infusion of ApTOLL

Stroke Clinical Trial

— APTABOLUS  

Official title:

First in Human Clinical Trial to Compare Safety and Tolerability Between Intravenous Infusions and Bolus Intravenous Inhection of ApTOLL in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05569720
• Other study ID #: APTABOLUS
• Status: Completed
• Phase: Phase 1
• Start date: April 25, 2022
• Est. completion date: June 24, 2022

Study information

• Verified date: October 2022
• Source: aptaTargets S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 24, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• ApTOLL
ApTOLL will be administered as follows: Day 1: a dose of 0.1mg/kg will be administered intravenously as a slow infusion. Day 2: a dose of 0.1mg/kg will be administered intravenously as single bolus injection. Day 3: a dose of 0.2mg/kg will be administered intravenously as single bolus injection.

Locations

Country	Name	City	State
Spain	Clinical Pharmacology Department. Hospital Universitario de La Princesa	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
aptaTargets S.L.	Centro para el Desarrollo Tecnológico Industrial

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Fernández G, Moraga A, Cuartero MI, García-Culebras A, Peña-Martínez C, Pradillo JM, Hernández-Jiménez M, Sacristán S, Ayuso MI, Gonzalo-Gobernado R, Fernández-López D, Martín ME, Moro MA, González 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. — View Citation

Hernández-Jiménez M, Martín-Vílchez S, Ochoa D, Mejía-Abril G, Román M, Camargo-Mamani P, Luquero-Bueno S, Jilma B, Moro MA, Fernández G, Piñeiro D, Ribó M, González 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	To evaluate the safety and tolerability between different ways of ApTOLL administration: intravenous infusion versus bolus intravenous injection, and pharmacokinetic characteristics of ApTOLL in healthy volunteers after single dose administration in fasting conditions.	day 1 to day 28