Still's Disease, Adult-OnsetPhase 1NCT05715736
Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3
A Phase 1 study testing APB-R3 in people with Still's Disease, Adult-Onset, run by Syneos Health at 1 site in Australia.
Trial summary
This will be a single centre, Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Still's Disease, Adult-Onset
- What is being tested?
- APB-R3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Mar 2023to 19 Dec 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, non-smoker, 18 to 60 years of age (both inclusive),
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration in the opinion of the investigator.
- the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease in the opinion of the investigator.
Who cannot join
- Abnormal finding at physical examination
- Evidence of clinical significant hepatic or renal impairment
- Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, or positive test results for COVID-19, or QuantiFERON®-TB test at screening.
- Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants
This will be a single centre, Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants.
Read the detailed description
Primary objective of this study will be to evaluate the safety and tolerability of APB-R3 following intravenous (IV) administration of single ascending dose in healthy participants.
The study will consist of 5 planned cohorts (1 cohort per dose level) for a total of up to 31 participants. Cohorts 1 and 2 will include 5 participants each (3 participants receiving the active and 2 participants receiving the placebo). Cohort 3 to Cohort 5 will include 7 participants each (5 participants receiving the active and 2 participants receiving the placebo).
- Conditions
- Still's Disease, Adult-Onset
- Being tested
- APB-R3, Placebo
- Medical subject headings
- Still's Disease, Adult-Onset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APB-R3Drug
APB-R3 is formulated as a sterile solution containing APB-R3 as the active substance administered intravenously.
PlaceboDrug
0.90% Normal Saline only
| Study group | Role | What they receive |
|---|---|---|
| SAD cohort | Experimental | SAD cohorts 1-5. Randomised participants in each cohort will receive a single IV dose of APB-R3. Receives: Drug: APB-R3 |
| Placebo | Placebo comparator | SAD cohorts 1-5. 2 randomised participants of each cohort will receive a placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of APB-R3 following IV administration of single ascending dose in healthy participants.
Number of participants with serious and other non-serious adverse events.
Measured: Upto 92 days
Secondary outcomes (15)
PK (Pharmacokinetic) assessment of APB-R3
AUC0-t will be assessed.
Measured: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
AUC0-inf will be assessed.
Measured: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Cmax will be assessed.
Measured: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Tmax will be assessed.
Measured: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Ceoi will be assessed.
Measured: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
MRT will be assessed.
Measured: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Residual area will be assessed.
Measured: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
T½ el will be assessed.
Measured: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Kel will be assessed.
Measured: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Cl will be assessed.
Measured: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Vz will be assessed.
Measured: Upto 92 days
PD (Pharmacodynamics) effect assessment of APB-R3
AUEC0-t will be assessed.
Measured: Upto 92 days
PD (Pharmacodynamics) effect assessment of APB-R3
Cmax will be assessed.
Measured: Upto 92 days
PD (Pharmacodynamics) effect assessment of APB-R3
Tmax will be assessed.
Measured: Upto 92 days
Immunogenicity assessment of APB-R3
The percentage of participants with anti-drug antibodies (ADA) to APB-R3 will be assessed.
Measured: Upto 92 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start8 Mar 2023
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Still's Disease, Adult-OnsetStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneos Health
- Sponsor type
- University, hospital or other
- Collaborators
- AprilBio Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP, Principal investigator, CMAX Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715736
- Sponsor's protocol ID
- APB-R3-101
- Status last verified
- Feb 2023
- First submitted
- 17 Aug 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05715736
- Acronym / sponsor ID
- APB-R3-101
- Conditions
- Still's Disease, Adult-Onset
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Syneos HealthUniversity, hospital or other
- Collaborators
- AprilBio Co., Ltd.
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 8 Feb 2023 (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 will be a single centre, Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants.
Detailed description
Primary objective of this study will be to evaluate the safety and tolerability of APB-R3 following intravenous (IV) administration of single ascending dose in healthy participants.
The study will consist of 5 planned cohorts (1 cohort per dose level) for a total of up to 31 participants. Cohorts 1 and 2 will include 5 participants each (3 participants receiving the active and 2 participants receiving the placebo). Cohort 3 to Cohort 5 will include 7 participants each (5 participants receiving the active and 2 participants receiving the placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAD cohort | Experimental | Drug: APB-R3SAD cohorts 1-5. Randomised participants in each cohort will receive a single IV dose of APB-R3. |
| Placebo | Placebo comparator | Drug: PlaceboSAD cohorts 1-5. 2 randomised participants of each cohort will receive a placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female, non-smoker, 18 to 60 years of age (both inclusive),
- Healthy as defined by:
Key exclusion criteria (4 listed)
- Abnormal finding at physical examination
- Evidence of clinical significant hepatic or renal impairment
- Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, or positive test results for COVID-19, or QuantiFERON®-TB test at screening.
- Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
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 |
|---|---|---|
| APB-R3APB-R3 is formulated as a sterile solution containing APB-R3 as the active substance administered intravenously. | Drug | SAD cohort |
| Placebo0.90% Normal Saline only | Drug | Placebo |
Primary outcome
To evaluate the safety and tolerability of APB-R3 following IV administration of single ascending dose in healthy participants.
Time frame: Upto 92 days
Number of participants with serious and other non-serious adverse events.
15 secondary outcomes
PK (Pharmacokinetic) assessment of APB-R3
Time frame: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Time frame: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Time frame: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Time frame: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Time frame: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Time frame: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Time frame: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Time frame: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Time frame: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Time frame: Upto 92 days
PK (Pharmacokinetic) assessment of APB-R3
Time frame: Upto 92 days
PD (Pharmacodynamics) effect assessment of APB-R3
Time frame: Upto 92 days
PD (Pharmacodynamics) effect assessment of APB-R3
Time frame: Upto 92 days
PD (Pharmacodynamics) effect assessment of APB-R3
Time frame: Upto 92 days
Immunogenicity assessment of APB-R3
Time frame: Upto 92 days
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 8 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Still's Disease, Adult-Onset
RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
Active, not recruitingObservational study
A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease
Still's Disease, Adult-Onset
RecruitingPhase 2
A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
Still´s Disease
Active, not recruiting
Therapeutic Value of Sirolimus in Refractory Adult-Onset Still's Disease
Adult-Onset Still's Disease
RecruitingObservational study
A Study on the Use of Canakinumab Among Familial Mediterranean Fever and Still's Disease Patients
Familial Mediterranean Fever, Still Disease
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.
Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP principal investigator
CMAX Clinical Research
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 APB-R3 in people with Still's Disease, Adult-Onset, run by Syneos Health 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 4 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 8 Jan 2024. 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?
To evaluate the safety and tolerability of APB-R3 following IV administration of single ascending dose in healthy participants. (time frame: Upto 92 days). 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 8 Jan 2024.