CMAX Clinical Research
Adelaide, South Australia, 5000, Australia
NCT Number: NCT05715736
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Adelaide, South Australia, 5000, Australia
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
APB-R3 is formulated as a sterile solution containing APB-R3 as the active substance administered intravenously.
0.90% Normal Saline only
Time frame: Upto 92 days
Number of participants with serious and other non-serious adverse events.
Time frame: Upto 92 days
AUC0-t will be assessed.
Time frame: Upto 92 days
AUC0-inf will be assessed.
Time frame: Upto 92 days
Cmax will be assessed.
Time frame: Upto 92 days
Tmax will be assessed.
Time frame: Upto 92 days
Ceoi will be assessed.
Time frame: Upto 92 days
MRT will be assessed.
Time frame: Upto 92 days
Residual area will be assessed.
Time frame: Upto 92 days
T½ el will be assessed.
Time frame: Upto 92 days
Kel will be assessed.
Time frame: Upto 92 days
Cl will be assessed.
Time frame: Upto 92 days
Vz will be assessed.
Time frame: Upto 92 days
AUEC0-t will be assessed.
Time frame: Upto 92 days
Cmax will be assessed.
Time frame: Upto 92 days
Tmax will be assessed.
Time frame: Upto 92 days
The percentage of participants with anti-drug antibodies (ADA) to APB-R3 will be assessed.
Syneos Health
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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