Pharmacokinetic and Safety Study of Subcutaneous and Intravenous Anifrolumab Delivered in Healthy Adult Participants

NCT06662123 | Completed Phase 1 FDA Drug

• 1 other identifier: D3465C00004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (10)

• SC and IV Arm: Area under the serum concentration-time curve from the pre-dose concentration extrapolated to infinity (AUCinf)

  The concentration of anifrolumab in serum will be determined (AUCinf will be derived).

  At predefined intervals throughout the study period (From Day 1 to Day 57)

• SC and IV Arm: Maximum observed serum (peak) concentration (Cmax)

  The concentration of anifrolumab in serum will be determined (Cmax will be derived).

  At predefined intervals throughout the study period (From Day 1 to Day 57)

• SC and IV Arm: Time to reach peak or maximum observed concentration (tmax)

  The concentration of anifrolumab in serum will be determined (tmax will be derived).

  At predefined intervals throughout the study period (From Day 1 to Day 57)

• SC and IV Arm: Area under the serum concentration-time curve from pre-dose concentration to time of last quantifiable concentration (AUClast)

  The concentration of anifrolumab in serum will be determined (AUClast will be derived).

  At predefined intervals throughout the study period (From Day 1 to Day 57)

• SC and IV Arm: half-life associated with the terminal slope of a semi-logarithmic concentration-time curve (t½λz)

  The concentration of anifrolumab in serum will be determined (t½λz will be derived).

  At predefined intervals throughout the study period (From Day 1 to Day 57)

• Bioavailability (F)

  The concentration of anifrolumab in serum will be determined (F will be derived).

  At predefined intervals throughout the study period (From Day 1 to Day 57)

• SC Arm: Apparent total body clearance of drug after extravascular administration (CL/F)

  The concentration of anifrolumab in serum will be determined (CL/F will be derived).

  At predefined intervals throughout the study period (From Day 1 to Day 57)

• SC Arm:Volume of distribution during the terminal phase after extravascular administration (Vz/F)

  The concentration of anifrolumab in serum will be determined (Vz/F will be derived).

  At predefined intervals throughout the study period (From Day 1 to Day 57)

• IV Arm: volume of distribution during the terminal phase after intravenous administration (Vz)

  The concentration of anifrolumab in serum will be determined (Vz will be derived).

  At predefined intervals throughout the study period (From Day 1 to Day 57)

• IV Arm: Apparent total body clearance of drug after intravenous administration (CL)

  The concentration of anifrolumab in serum will be determined (CL will be derived).

  At predefined intervals throughout the study period (From Day 1 to Day 57)

Secondary Outcomes (12)

• Adverse Event

  From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)

• Vital Signs of blood pressure

  From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)

• 12-lead ECG measurements include heart rate, RR interval, PR interval, QRS duration, and QT interval

  From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)

• 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

  From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)

• Physical examination of height

  From the time of signature of the ICF, throughout the study and including the follow-up period (approximately 12 weeks)

Study Arms (2)

Subcutaneous

EXPERIMENTAL

Drug: Anifrolumab

Intravenous

EXPERIMENTAL

Drug: Anifrolumab

Interventions

Anifrolumab DRUG

Participants will receive a single SC or IV dose of anifrolumab at day 1

Also known as: Saphnelo

Intravenous; Subcutaneous

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Wuhan, 430022, China

Location

MeSH Terms

Interventions

anifrolumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: October 28, 2024
• Study Start: October 21, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

CN (1)