Clinical trial NCT06662123: Pharmacokinetic and Safety Study of Subcutaneous and Intravenous Anifrolumab Delivered in Healthy Adult Participants
Official title: A Randomized, Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Subcutaneously and Intravenously Delivered Anifrolumab in Healthy Chinese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, Phase I, open-label, single-dose study to evaluate the PK, safety, and tolerability of anifrolumab administered to male and female healthy Chinese participants aged 18 to 55 years. Approximately 24 participants, who fulfill the eligibility criteria, will be administered anifrolumab via SC route or IV route, and participants will be randomized to the two arms in a 1:1 ratio.

Detailed description: The purpose of this study is to evaluate the PK, safety, and tolerability of a single dose of anifrolumab subcutaneously or intravenously administered to healthy Chinese participants aged 18 to 55 years. The primary study endpoints are PK standard endpoints. The secondary study endpoints are standard endpoints for safety assessment, including adverse events, serious adverse events, and clinical safety laboratory measurements. The participants must abstain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study intervention until completion of the follow-up visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.

Eligibility criteria: Inclusion Criteria:

* Able to complete the follow-up visit as required by the protocol.
* Participant must be 18 to 55 years of age (both inclusive), at the time of signature of the ICF.
* A body mass index of ≥ 18.5 to ≤ 26.0 kg/m2 and body weight of at least 45 kg for females and 50 kg for males at screening.
* Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

* History of malignancy with some exceptions
* History of alcohol or drug abuse within the past 2 years.
* Any significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data.

Primary outcomes:
measure: SC and IV Arm: Area under the serum concentration-time curve from the pre-dose concentration extrapolated to infinity (AUCinf)
timeFrame: At predefined intervals throughout the study period (From Day 1 to Day 57)
measure: SC and IV Arm: Maximum observed serum (peak) concentration (Cmax)
timeFrame: At predefined intervals throughout the study period (From Day 1 to Day 57)
measure: SC and IV Arm: Time to reach peak or maximum observed concentration (tmax)
timeFrame: At predefined intervals throughout the study period (From Day 1 to Day 57)
measure: SC and IV Arm: Area under the serum concentration-time curve from pre-dose concentration to time of last quantifiable concentration (AUClast)
timeFrame: At predefined intervals throughout the study period (From Day 1 to Day 57)
measure: SC and IV Arm: half-life associated with the terminal slope of a semi-logarithmic concentration-time curve (t½λz)
timeFrame: At predefined intervals throughout the study period (From Day 1 to Day 57)
measure: Bioavailability (F)
timeFrame: At predefined intervals throughout the study period (From Day 1 to Day 57)
measure: SC Arm: Apparent total body clearance of drug after extravascular administration (CL/F)
timeFrame: At predefined intervals throughout the study period (From Day 1 to Day 57)
measure: SC Arm:Volume of distribution during the terminal phase after extravascular administration (Vz/F)
timeFrame: At predefined intervals throughout the study period (From Day 1 to Day 57)
measure: IV Arm: volume of distribution during the terminal phase after intravenous administration (Vz)
timeFrame: At predefined intervals throughout the study period (From Day 1 to Day 57)
measure: IV Arm: Apparent total body clearance of drug after intravenous administration (CL)
timeFrame: At predefined intervals throughout the study period (From Day 1 to Day 57)
Secondary outcomes:
measure: Adverse Event
timeFrame: From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)
measure: Vital Signs of blood pressure
timeFrame: From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)
measure: 12-lead ECG measurements include heart rate, RR interval, PR interval, QRS duration, and QT interval
timeFrame: From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)
measure: Safety haematology laboratory parameters: WBC, Neutrophils absolute count, RBC, Lymphocytes absolute count, Hb, Monocytes absolute count, HCT, Eosinophils absolute count, MCV, Basophils absolute count, MCH, Platelets, MCHC, Reticulocytes absolute count
timeFrame: From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)
measure: Physical examination of height
timeFrame: From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)
measure: Vital Signs of pulse rate
timeFrame: From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)
measure: Vital Signs of body temperature
timeFrame: From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)
measure: Vital Signs of respiratory rate
timeFrame: From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)
measure: Safety clinical chemistry laboratory parameters: Sodium, CRP, Potassium, ALP, Urea, ALT, Creatinine, AST, Albumin, GGT, Calcium, TBL, Phosphate, Conjugated bilirubin, Glucose, Creatine kinase
timeFrame: From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)
measure: Safety urinalysis laboratory parameters: Glucose Protein, Blood, Microscopy (if positive for protein or blood)
timeFrame: From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)
measure: Physical examination of weight
timeFrame: From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)
measure: Physical examination of general appearance, the lungs, cardiovascular system, and the abdomen
timeFrame: From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Research Site
Study officials:
References: