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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04650126




Registration number
NCT04650126
Ethics application status
Date submitted
5/11/2020
Date registered
2/12/2020
Date last updated
21/07/2022

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab (ATM001) in Healthy Volunteers
Scientific title
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.
Secondary ID [1] 0 0
ATM001-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ATM001
Treatment: Other - ATM001 Placebo

Experimental: ATM001 - Escalating dose levels of ATM001 administered as single dose in healthy subjects

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


Treatment: Other: ATM001
monovalent anti-TNF-receptor 1 antibody format

Treatment: Other: ATM001 Placebo
ATM001 Placebo
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
pharmacokinetic (PK): Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC 0-8)
Timepoint [1] 0 0
8 days
Primary outcome [2] 0 0
PK: Area under the plasma concentration curve from administration until the last quantifiable sampling point (AUC 0-t)
Timepoint [2] 0 0
8 days
Primary outcome [3] 0 0
PK: Maximum Plasma Concentration [Cmax]
Timepoint [3] 0 0
8 days
Primary outcome [4] 0 0
PK: Terminal half life (t1/2)
Timepoint [4] 0 0
8 days
Primary outcome [5] 0 0
PK: Apparent terminal elimination rate constant (?z)
Timepoint [5] 0 0
8 days
Primary outcome [6] 0 0
PK: Mean residence time (MRT)
Timepoint [6] 0 0
8 days
Primary outcome [7] 0 0
PK: Clearance (CL)
Timepoint [7] 0 0
8 days
Primary outcome [8] 0 0
PK: Apparent volume of distribution (Vz)
Timepoint [8] 0 0
8 days
Primary outcome [9] 0 0
Any adverse event, serious adverse event (SAE)
Timepoint [9] 0 0
4 weeks

Eligibility
Key inclusion criteria
* healthy male subjects
* body mass index 18-32 kg/m2
* normal physical examination, clinical laboratory values and ECG
* additional inclusion criteria apply
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/03/2022
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
Brisban
Recruitment hospital [1] 0 0
Q-Pharm - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Baliopharm Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT04650126
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kristi McLendon, MD
Address 0 0
Q-Pharm Pty Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04650126