NCT06115967

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of AZD6912 administered subcutaneously (SC) in healthy participants.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Nov 2023

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2025

Completed
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

October 16, 2023

Last Update Submit

November 27, 2025

Conditions

Rheumatoid Arthritis

Keywords

Complement factor BSmall interfering ribonucleic acidCFB messenger ribonucleic acid

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events (AEs)

    To assess the safety and tolerability of AZD6912 in healthy participants.

    From screening (Day -70) to last follow up visit (Day 197- approximately 38 weeks)

Secondary Outcomes (13)

  • Maximum observed plasma (peak) drug concentration (Cmax) of AZD6912

    From randomization to Day 197 (up to 28 weeks)

  • Area under plasma concentration-time curve from zero to infinity (AUCinf) of AZD6912

    From randomization to Day 197 (up to 28 weeks)

  • Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD6912

    From randomization to Day 197 (up to 28 weeks)

  • Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD6912

    From randomization to Day 197 (up to 28 weeks)

  • Time of last measurable concentration (tlast) of AZD6912

    From randomization to Day 197 (up to 28 weeks)

  • +8 more secondary outcomes

Study Arms (9)

AZD6912 Dose 1

EXPERIMENTAL

Participants will receive AZD6912 Dose 1.

Drug: AZD6912

AZD6912 Dose 2

EXPERIMENTAL

Participants will receive AZD6912 Dose 2.

Drug: AZD6912

AZD6912 Dose 3

EXPERIMENTAL

Participants will receive AZD6912 Dose 3.

Drug: AZD6912

AZD6912 Dose 4

EXPERIMENTAL

Participants will receive AZD6912 Dose 4.

Drug: AZD6912

AZD6912 Dose 5

EXPERIMENTAL

Participants will receive AZD6912 Dose 5.

Drug: AZD6912

AZD6912 Dose 6

EXPERIMENTAL

Participants will receive AZD6912 Dose 6.

Drug: AZD6912

Placebo

PLACEBO COMPARATOR

Participants will receive Placebo.

Drug: Placebo

AZD6912 additional Japanese cohort 1

EXPERIMENTAL

Participants will receive AZD6912.

Drug: AZD6912

AZD6912 additional Japanese cohort 2

EXPERIMENTAL

Participants will receive AZD6912.

Drug: AZD6912

Interventions

AZD6912DRUG

AZD6912 will be administered as a single sub-cutaneous dose.

AZD6912 Dose 1AZD6912 Dose 2AZD6912 Dose 3AZD6912 Dose 4AZD6912 Dose 5AZD6912 Dose 6AZD6912 additional Japanese cohort 1AZD6912 additional Japanese cohort 2
PlaceboDRUG

Placebo will be administered as a single sub-cutaneous dose.

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females must have a negative pregnancy test.
  • Contraceptive use by males and females should be consistent with local regulations.
  • Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
  • For optional Japanese participants only:
  • Participants must be of Japanese descent defined as: first generation (born to 2 Japanese parents and 4 Japanese grandparents).
  • Born in Japan, and not have lived outside Japan for more than 5 years.
  • Lifestyle, including diet, must not have significantly changed since leaving Japan.

You may not qualify if:

  • History of any clinically important disease or disorder.
  • Current or recurrent disease of clinical significance that could affect clinical assessments or clinical laboratory evaluations.
  • Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention.
  • History of congenital or acquired immunodeficiency or complement deficiency or an underlying condition that predisposes to infection.
  • History of any Neisseria infection, unexplained, recurrent infections, or infection requiring treatment with systemic antibiotics.
  • Evidence of hepatitis B infection (positive for HBsAg or positive for anti-HBcAb) or hepatitis C viral infection (HCV Abs or hepatitis C RNA positive) or HIV infection (positive for HIV type 1 or type 2 Abs).
  • Participants testing positive for COVID-19 prior to dosing.
  • Any cardiac abnormalities.
  • A CAP activity \< 60% at screening.
  • Known or suspected history of drug abuse, history of alcohol abuse or smoking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Montreal, Quebec, H3P 3P1, Canada

Location

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2023

First Posted

November 3, 2023

Study Start

November 15, 2023

Primary Completion

October 16, 2025

Study Completion

October 16, 2025

Last Updated

December 1, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Shared Documents
STUDY PROTOCOL
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 refer 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

GB(1)CA(1)