Study Complete
Sponsor ID
20200286

A Study Comparing the Pharmacokinetics (PK) of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 ml (ABP 501-LCF) in Healthy Adult Participants

Sponsor ID
20200286
Clinicaltrials.gov ID
NCT05909852
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and maximum observed serum concentration (Cmax) in healthy adult participants.

Additional Study Details

Phase
Phase 1
Product
ABP 501
Type
Interventional
Masking
Single (Participant)
Enrollment
372
Additional Study Details

Protocol Summary

Primary Outcome Measures

AUCinf of ABP 501-HCF and ABP 501-LCF

Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63

Cmax of ABP 501-HCF and ABP 501-LCF

Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63

Secondary Outcome Measures

AUC from Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of ABP 501-HCF and ABP 501-LCF

Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63

Time at which Cmax is Observed (Tmax) of ABP 501-HCF and ABP 501-LCF

Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63

Terminal Elimination Half-life (t1/2) of ABP 501-HCF and ABP 501-LCF

Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63

Apparent Clearance (CL/F) of ABP 501-HCF and ABP 501-LCF

Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63

Apparent Volume of Distribution (Vz/F) of ABP 501-HCF and ABP 501-LCF

Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63

Mean Residence Time (MRT) of ABP 501-HCF and ABP 501-LCF

Timeframe: Pre-dose (Day 1), 8 hours post-dose (Day 1), Days 2 to 9, Days 11, 14, 16, 22, 29, 36, 43, 50, 57, and 63

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Timeframe: Day 1 until Day 63

Number of Participants with an Event of Interest

Timeframe: Day 1 until Day 63

Number of Participants with Binding and Neutralizing Anti-drug Antibodies

Timeframe: Pre-dose Day 1, Day 16, Day 29, and Day 63

Locations

Location
Status
Contact Us
Location
QPS-MRA, LLC
South Miami, Florida, United States, 33143
Status
Completed
Location
Pharmaceutical Research Associates, Inc
Salt Lake City, Utah, United States, 84124
Status
Completed
Location
WCCT Global, Inc
Cypress, California, United States, 90630
Status
Completed