Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab (ATM001) in Healthy Volunteers

Baliopharm

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: ATM001 Placebo; Biological: ATM001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04650126

ATM001-001

Details and patient eligibility

About

This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers

Enrollment: 42 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male subjects
• body mass index 18-32 kg/m2
• normal physical examination, clinical laboratory values and ECG
• additional inclusion criteria apply

Exclusion criteria

• febrile or infectious illness at least 7 days prior to the first administration
• any active physical disease, acute or chronic
• history of alcohol or drug abuse
• history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric, or cardio-vascular disease, myopathies and bleeding tendency
• additional exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

ATM001

Experimental group

Description:

Escalating dose levels of ATM001 administered as single dose in healthy subjects

Treatment:

Biological: ATM001

ATM001 Placebo

Placebo Comparator group

Description:

Escalating dose levels of ATM001 Placebo administered as single dose in healthy subjects

Treatment:

Biological: ATM001 Placebo