Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab (ATM001) in Healthy Volunteers
A Phase I, Randomized, Double-blind, Parallel Group and Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab in Response to Single Ascending Intravenous Infusion Doses.
1 other identifier
interventional
42
1 country
1
Brief Summary
This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
Started Jul 2021
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2020
CompletedFirst Posted
Study publicly available on registry
December 2, 2020
CompletedStudy Start
First participant enrolled
July 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2022
CompletedJuly 21, 2022
July 1, 2021
9 months
November 5, 2020
July 20, 2022
Conditions
Outcome Measures
Primary Outcomes (9)
pharmacokinetic (PK): Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC 0-∞)
8 days
PK: Area under the plasma concentration curve from administration until the last quantifiable sampling point (AUC 0-t)
8 days
PK: Maximum Plasma Concentration [Cmax]
8 days
PK: Terminal half life (t1/2)
8 days
PK: Apparent terminal elimination rate constant (λz)
8 days
PK: Mean residence time (MRT)
8 days
PK: Clearance (CL)
8 days
PK: Apparent volume of distribution (Vz)
8 days
Any adverse event, serious adverse event (SAE)
4 weeks
Study Arms (2)
ATM001
EXPERIMENTALEscalating dose levels of ATM001 administered as single dose in healthy subjects
ATM001 Placebo
PLACEBO COMPARATOREscalating dose levels of ATM001 Placebo administered as single dose in healthy subjects
Interventions
Eligibility Criteria
You may qualify if:
- healthy male subjects
- body mass index 18-32 kg/m2
- normal physical examination, clinical laboratory values and ECG
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Q-Pharm
Herston, Brisbane, 4006, Australia
Study Officials
- PRINCIPAL INVESTIGATOR
Kristi McLendon, MD
Q-Pharm Pty Limited
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2020
First Posted
December 2, 2020
Study Start
July 12, 2021
Primary Completion
March 24, 2022
Study Completion
March 24, 2022
Last Updated
July 21, 2022
Record last verified: 2021-07