Phase 1Phase 1NCT03983876
PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)
A Phase 1 study testing Adalimumab in people with Phase 1, run by Alvotech Swiss AG at 2 sites in New Zealand.
Trial summary
This study has been designed as a multicentre, randomised, open label study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in Pre-Filled Syringe compared to AVT02 in Autoinjector Pen. Both arms will use single dose of 40mg of AVT02 (Adalimumab) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Phase 1
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 1 Jul 2019to 3 Dec 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria:To be eligible for study entry, subjects must satisfy all of the following criteria:
- Male or female healthy adult subjects willing to sign a patient information and consent form (PICF) and able to undergo protocol related procedures;
- Age: 18 to 55 years, inclusive;
- Body Mass Index: 18.5 to 32.0 kg/m2;
- No history or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator would pose a risk to subject safety;
- Resting supine systolic blood pressure (BP) of ≤150 mmHg and diastolic BP of ≤90 mmHg. Other vital signs showing no clinically relevant deviations according to the investigator's judgment;
- 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the investigator;
- Negative urine drug screen and negative alcohol breath test at screening and admission;
- Subjects smokes <10 cigarettes per day within 3 months of screening and is able to abide by the smoking policy of the site;
- Ability and willingness to abstain from alcohol from 48 hours prior to IP administration, during confinement in the study site until discharge from the confinement period and 24 hours prior to ambulatory visits;
- Females must have a negative pregnancy test at screening and on admission to the study site, must not be lactating and must agree to sexual abstinence or the use effective contraception, starting at screening and continue throughout the study period up to the end of study (EOS) visit;
- Male subjects and their female spouse/partners who are of childbearing potential must agree to using 2 forms of birth control (1 of which is a highly effective method and 1 must be a barrier method), or agree to sexual abstinence, starting at screening and continue throughout the study period up to the EOS visit;
- Male subject must not donate sperm starting at screening and throughout the study period up to the EOS visit;
Exclusion Criteria:To be eligible for study entry, subjects must satisfy all of the following criteria:
- Male or female healthy adult subjects willing to sign a patient information and consent form (PICF) and able to undergo protocol related procedures;
- Age: 18 to 55 years, inclusive;
- Body Mass Index: 18.5 to 32.0 kg/m2;
- No history or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator would pose a risk to subject safety;
- Resting supine systolic blood pressure (BP) of ≤150 mmHg and diastolic BP of ≤90 mmHg. Other vital signs showing no clinically relevant deviations according to the investigator's judgment;
- 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the investigator;
- Negative urine drug screen and negative alcohol breath test at screening and admission;
- Subjects smokes <10 cigarettes per day within 3 months of screening and is able to abide by the smoking policy of the site;
- Ability and willingness to abstain from alcohol from 48 hours prior to IP administration, during confinement in the study site until discharge from the confinement period and 24 hours prior to ambulatory visits;
- Females must have a negative pregnancy test at screening and on admission to the study site, must not be lactating and must agree to sexual abstinence or the use effective contraception, starting at screening and continue throughout the study period up to the end of study (EOS) visit;
- Male subjects and their female spouse/partners who are of childbearing potential must agree to using 2 forms of birth control (1 of which is a highly effective method and 1 must be a barrier method), or agree to sexual abstinence, starting at screening and continue throughout the study period up to the EOS visit;
- Male subject must not donate sperm starting at screening and throughout the study period up to the EOS visit;
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Auckland Clinical Studies
Auckland
Christchurch Clinical Studies Trust Limited
Christchurch, Chistchurch, 8011
About this study
Official title: Multi-center, Randomized, Open-Label, 2-Arm Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of AVT02 Administered Subcutaneously Via Prefilled Syringe or Autoinjector in Healthy Adult Volunteers (ALVOPAD PEN)
This study has been designed as a multicentre, randomised, open label study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in Pre-Filled Syringe compared to AVT02 in Autoinjector Pen. Both arms will use single dose of 40mg of AVT02 (Adalimumab)
Read the detailed description
This study is designed as a multi-center, randomized, open-label, 2-arm parallel study of AVT02 administered via a PFS either manually via an autoinjector, in healthy adult subjects.
A total of 204 subjects will be recruited into this study and will be randomly assigned with a ratio of 1:1 to receive either AVT02 manually or via autoinjector. As the study is open-label, both the site staff and the subjects themselves will know which treatments are being administered.
The study consists of a screening period, admission and treatment period, assessment period and end of study (EOS) visit. Subjects will undertake a screening visit between Day -28 and Day -1 to determine eligibility in the study. Those subjects that meet the eligibility criteria will be admitted to the study site on the evening prior to dosing (Day -1) when continued eligibility will be assessed.
On Day 1 prior to dosing, baseline assessments will be performed. Subjects will then be dosed according to the randomization schedule. Following dosing, PK, safety, tolerability and immunogenicity assessments will be performed according to the study schedule (Table 6). Subjects will remain confined to the study site from Day -1 to Day 3 (48 hours post-dose). Subjects will return to the study site on Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 12, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50 and Day 57.
An EOS visit will occur at study Day 64 for final study assessments. The EOS visit will also be the early termination visit if required (to be completed within 7 days of early termination wherever possible).
- Conditions
- Phase 1
- Being tested
- Adalimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira ATC code L04AB0
AVT02, a proposed similar biological product (biosimilar) of Humira which contains adalimumab . Adalimumab is a recombinant, fully human monoclonal immunoglobulin G1 (IgG1) antibody that binds specifically and with high affinity to the soluble and transmembrane forms of tumor necrosis factor (TNF)-α thereby inhibiting the binding of TNF-α with its receptor, and inhibiting TNF -α's biological function.
Tumor necrosis factor-α is a naturally occurring cytokine that is key to normal inflammatory and immune responses. Elevated levels of TNF-α are found in the synovial fluid of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients and psoriasis plaques and play an important role in both the pathologic inflammation and joint destruction that are hallmarks of these inflammatory disease
| Study group | Role | What they receive |
|---|---|---|
| AVT02 100mg/mL in PFS | Experimental | Prefilled Syringe Arm Receives: Drug: Adalimumab |
| AVT02 100mg/mL in Autoinjector | Experimental | Autoinjector Arm Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve AUC0-t
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02 given in PFS and AVT02 given in autoinjector
Measured: From baseline to day 64
Area under the plasma concentration-time curve AUC0-inf
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02 given in PFS and AVT02 given in autoinjector
Measured: From baseline to day 64
Maximum serum concentration
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02 given in PFS and AVT02 given in autoinjector
Measured: From baseline to day 64
Secondary outcomes (3)
Pain, Tenderness, Erythema and Swelling
The injection sites will be monitored for pain, tenderness, erythema and swelling. Each injection site reaction will be categorised using the Injection Site Intensity Grading Scheme. All four outcome measures mentioned in the title will be measured from this one scheme. According to the Intensity Grading Scheme, the Pain, Tenderness, Erythema and Swelling will be measured as Absent (0), Mild (1), Moderate Severe(3) and Potentially Life Threatening.
Measured: From baseline to day 64
Anti Drug Antibodies (ADRs)
Immunogenicity response will be determined from all patients treated with AVT02 from baseline to day 64 with a validated assay. Immunogenicity results (number of positive tested subjects/number of negative tested subjects; titer) will be summarized by treatment group (prefilled syringe group vs. autoinjector group). Immunogenicity assessments include antidrug antibodies (ADAs) and neutralizing antibodies (NAbs).
Measured: From baseline to day 64
Adverse Events
Adverse events will be coded using MedDRA and grouped by system organ class and preferred term and summarised, by treatment group at the time of onset of the AE. The summary tables will present the number and percentage of total subjects and number of events, by system organ class and by preferred term. Injection related reactions will be listed and summarised by reaction using frequency counts and percentage, by treatment group
Measured: Baseline to day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start1 Jul 2019
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase 1Studies 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
- Model description
- This is an open-label, 2-arm parallel study of AVT02 (Administered via a PFS either manually via an autoinjector, in healthy adult subjects. The subjects in both arms will receive the same dose of AVT02, but in two different delivery modes.
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvotech Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983876
- Sponsor's protocol ID
- AVT02-GL-102
- Status last verified
- May 2022
- First submitted
- 10 Jun 2019
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Open-Label, 2-Arm Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of AVT02 Administered Subcutaneously Via Prefilled Syringe or Autoinjector in Healthy Adult Volunteers (ALVOPAD PEN)
- ClinicalTrials.gov ID
- NCT03983876
- Acronym / sponsor ID
- AVT02-GL-102
- Conditions
- Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Alvotech Swiss AGIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 12 Jun 2019 (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 study has been designed as a multicentre, randomised, open label study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in Pre-Filled Syringe compared to AVT02 in Autoinjector Pen. Both arms will use single dose of 40mg of AVT02 (Adalimumab)
Detailed description
This study is designed as a multi-center, randomized, open-label, 2-arm parallel study of AVT02 administered via a PFS either manually via an autoinjector, in healthy adult subjects.
A total of 204 subjects will be recruited into this study and will be randomly assigned with a ratio of 1:1 to receive either AVT02 manually or via autoinjector. As the study is open-label, both the site staff and the subjects themselves will know which treatments are being administered.
The study consists of a screening period, admission and treatment period, assessment period and end of study (EOS) visit. Subjects will undertake a screening visit between Day -28 and Day -1 to determine eligibility in the study. Those subjects that meet the eligibility criteria will be admitted to the study site on the evening prior to dosing (Day -1) when continued eligibility will be assessed.
On Day 1 prior to dosing, baseline assessments will be performed. Subjects will then be dosed according to the randomization schedule. Following dosing, PK, safety, tolerability and immunogenicity assessments will be performed according to the study schedule (Table 6). Subjects will remain confined to the study site from Day -1 to Day 3 (48 hours post-dose). Subjects will return to the study site on Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 12, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50 and Day 57.
An EOS visit will occur at study Day 64 for final study assessments. The EOS visit will also be the early termination visit if required (to be completed within 7 days of early termination wherever possible).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, 2-arm parallel study of AVT02 (Administered via a PFS either manually via an autoinjector, in healthy adult subjects. The subjects in both arms will receive the same dose of AVT02, but in two different delivery modes.
| Arm | Type | Receives |
|---|---|---|
| AVT02 100mg/mL in PFS | Experimental | Drug: AdalimumabPrefilled Syringe Arm |
| AVT02 100mg/mL in Autoinjector | Experimental | Drug: AdalimumabAutoinjector Arm |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| AdalimumabAlso: Humira ATC code L04AB0AVT02, a proposed similar biological product (biosimilar) of Humira which contains adalimumab . Adalimumab is a recombinant, fully human monoclonal immunoglobulin G1 (IgG1) antibody that binds specifically and with high affinity to the soluble and transmembrane forms of tumor necrosis factor (TNF)-α thereby inhibiting the binding of TNF-α with its receptor, and inhibiting TNF -α's biological function. Tumor necrosis factor-α is a naturally occurring cytokine that is key to normal inflammatory and immune responses. Elevated levels of TNF-α are found in the synovial fluid of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients and psoriasis plaques and play an important role in both the pathologic inflammation and joint destruction that are hallmarks of these inflammatory disease | Drug | AVT02 100mg/mL in Autoinjector, AVT02 100mg/mL in PFS |
Primary outcome
Area under the plasma concentration-time curve AUC0-t
Time frame: From baseline to day 64
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02 given in PFS and AVT02 given in autoinjector
Area under the plasma concentration-time curve AUC0-inf
Time frame: From baseline to day 64
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02 given in PFS and AVT02 given in autoinjector
Maximum serum concentration
Time frame: From baseline to day 64
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT02 given in PFS and AVT02 given in autoinjector
3 secondary outcomes
Pain, Tenderness, Erythema and Swelling
Time frame: From baseline to day 64
Anti Drug Antibodies (ADRs)
Time frame: From baseline to day 64
Adverse Events
Time frame: Baseline to day 84
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 4 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adalimumab in people with Phase 1, run by Alvotech Swiss AG at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. 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. 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?
Area under the plasma concentration-time curve AUC0-t (time frame: From baseline to day 64). The study lists 3 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 4 May 2022.