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

AptaTargets

Status and phase: Completed; Phase 1

Conditions: Stroke

Treatments: Drug: ApTOLL

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05569720

APTABOLUS

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

ApTOLL treatment

Experimental group

Description:

Volunteers will receive a dose of ApTOLL of 0.1mg/kg administered intravenously as slow infusion one day and as a single bolus intravenous injection the second day. In a third and last admission day, volunteers will receive a dose of ApTOLL of 0.2mg/kg administered as a single bolus intravenous injection.

Treatment:

Drug: ApTOLL