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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05569720

Acronym

APTABOLUS

Enrollment

Registered

2022-10-06

Start date

2022-04-25

Completion date

2022-06-24

Last updated

2022-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

DRUGApTOLL

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events	day 1 to day 28	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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026