Healthy VolunteersPhase 1NCT04650126
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab (ATM001) in Healthy Volunteers
A Phase 1 study testing ATM001 in people with Healthy Volunteers, run by Baliopharm Pty Ltd at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ATM001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Jul 2021to 24 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male subjects
- body mass index 18-32 kg/m2
- normal physical examination, clinical laboratory values and ECG
- additional inclusion criteria apply
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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.
This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers
- Conditions
- Healthy Volunteers
- Being tested
- ATM001, ATM001 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATM001Biological
Also called Atrosimab
monovalent anti-TNF-receptor 1 antibody format
ATM001 PlaceboBiological
ATM001 Placebo
| Study group | Role | What they receive |
|---|---|---|
| ATM001 | Experimental | Escalating dose levels of ATM001 administered as single dose in healthy subjects Receives: Biological: ATM001 |
| ATM001 Placebo | Placebo comparator | Escalating dose levels of ATM001 Placebo administered as single dose in healthy subjects Receives: Biological: ATM001 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic (PK): Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC 0-∞)
Measured: 8 days
PK: Area under the plasma concentration curve from administration until the last quantifiable sampling point (AUC 0-t)
Measured: 8 days
PK: Maximum Plasma Concentration [Cmax]
Measured: 8 days
PK: Terminal half life (t1/2)
Measured: 8 days
PK: Apparent terminal elimination rate constant (λz)
Measured: 8 days
PK: Mean residence time (MRT)
Measured: 8 days
PK: Clearance (CL)
Measured: 8 days
PK: Apparent volume of distribution (Vz)
Measured: 8 days
Any adverse event, serious adverse event (SAE)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start12 Jul 2021
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baliopharm Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristi McLendon, MD, Principal investigator, Q-Pharm Pty Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650126
- Sponsor's protocol ID
- ATM001-001
- Status last verified
- Jul 2021
- First submitted
- 5 Nov 2020
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT04650126
- Acronym / sponsor ID
- ATM001-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Baliopharm Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATM001 | Experimental | Biological: ATM001Escalating dose levels of ATM001 administered as single dose in healthy subjects |
| ATM001 Placebo | Placebo comparator | Biological: ATM001 PlaceboEscalating dose levels of ATM001 Placebo administered as single dose in healthy subjects |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy male subjects
- body mass index 18-32 kg/m2
- normal physical examination, clinical laboratory values and ECG
- additional inclusion criteria apply
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATM001Also: Atrosimabmonovalent anti-TNF-receptor 1 antibody format | Biological | ATM001 |
| ATM001 PlaceboATM001 Placebo | Biological | ATM001 Placebo |
Primary outcome
pharmacokinetic (PK): Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC 0-∞)
Time frame: 8 days
PK: Area under the plasma concentration curve from administration until the last quantifiable sampling point (AUC 0-t)
Time frame: 8 days
PK: Maximum Plasma Concentration [Cmax]
Time frame: 8 days
PK: Terminal half life (t1/2)
Time frame: 8 days
PK: Apparent terminal elimination rate constant (λz)
Time frame: 8 days
PK: Mean residence time (MRT)
Time frame: 8 days
PK: Clearance (CL)
Time frame: 8 days
PK: Apparent volume of distribution (Vz)
Time frame: 8 days
Any adverse event, serious adverse event (SAE)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristi McLendon, MD principal investigator
Q-Pharm Pty Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATM001 in people with Healthy Volunteers, run by Baliopharm Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacokinetic (PK): Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC 0-∞) (time frame: 8 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.