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Rheumatoid ArthritisPhase 1NCT06115967

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants

A Phase 1 study testing AZD6912 in people with Rheumatoid Arthritis, run by AstraZeneca at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
AZD6912
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
2 sitesin 2 countries
Study dates
15 Nov 2023to 16 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Canada1 site

  • Research Site

    Montreal, Quebec, H3P 3P1

Other trials in Canada

United Kingdom1 site

  • Research Site

    Harrow, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A Phase I, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants

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

Read the detailed description

In this First-In-Human (FiH) study, eligible participants will be randomly assigned to 6 cohorts in a 3:1 ratio to receive either a single dose of AZD6912 SC or placebo. The first 2 participants in each cohort will be dosed as a sentinel pair, with one receiving AZD6912 SC and the other receiving placebo.

The study will comprise of, a screening period of 70 days, a treatment period where participants will stay at the Clinical Unit from the day before study intervention administration until at least 240 hours and will be discharged on Day 11. Outpatient visits would start weekly from Day 15, then bi-weekly from Day 43, 4-weekly from Day 99, and 6-weekly from Day 155, with additional follow-up visits approximately every 4 weeks as needed until complement activity returns to the normal range.

The study will last approximately 25 months, including the optional Japanese cohorts, with each participant participating for about 38 weeks or longer until complement activity returns to normal range (per local laboratory).

Being tested
AZD6912, Placebo
Keywords
Complement factor B, Small interfering ribonucleic acid, CFB messenger ribonucleic acid
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD6912Drug

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

  • PlaceboDrug

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

Study groups in NCT06115967
Study groupRoleWhat they receive
AZD6912 Dose 1ExperimentalParticipants will receive AZD6912 Dose 1.
Receives: Drug: AZD6912
AZD6912 Dose 2ExperimentalParticipants will receive AZD6912 Dose 2.
Receives: Drug: AZD6912
AZD6912 Dose 3ExperimentalParticipants will receive AZD6912 Dose 3.
Receives: Drug: AZD6912
AZD6912 Dose 4ExperimentalParticipants will receive AZD6912 Dose 4.
Receives: Drug: AZD6912
AZD6912 Dose 5ExperimentalParticipants will receive AZD6912 Dose 5.
Receives: Drug: AZD6912
AZD6912 Dose 6ExperimentalParticipants will receive AZD6912 Dose 6.
Receives: Drug: AZD6912
PlaceboPlacebo comparatorParticipants will receive Placebo.
Receives: Drug: Placebo
AZD6912 additional Japanese cohort 1ExperimentalParticipants will receive AZD6912.
Receives: Drug: AZD6912
AZD6912 additional Japanese cohort 2ExperimentalParticipants will receive AZD6912.
Receives: Drug: AZD6912

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs)

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

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

Secondary outcomes (13)

  1. Maximum observed plasma (peak) drug concentration (Cmax) of AZD6912

    To characterise the Cmax of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

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

    To characterise AUCinf of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

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

    To characterise the AUClast of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

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

    To characterise tmax of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

  5. Time of last measurable concentration (tlast) of AZD6912

    To characterise tlast of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

  6. Terminal elimination half-life (t½λz) of AZD6912

    To characterise t½λz of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

  7. Dose normalised AUClast (AUClast/D) of AZD6912

    To characterise AUClast/D of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

  8. Dose normalised AUCinf (AUCinf/D) of AZD6912

    To characterise AUCinf/D of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

  9. Dose normalised Cmax (Cmax/D) of AZD6912

    To characterise Cmax/D of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

  10. Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD6912

    To characterise CL/F of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

  11. Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase) (Vz/F) of AZD6912

    To characterise Vz/F of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

  12. Percent change from baseline in plasma concentrations of Complement factor B (CFB) protein

    To assess the PD effects of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

  13. Percent change from baseline in serum of Complement functional activity (CAP)

    To assess the PD effects of single ascending doses of AZD6912 in healthy participants.

    Measured: From randomization to Day 197 (up to 28 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2023
  2. Study start15 Nov 2023
  3. Primary completion16 Oct 2025
  4. Study completion16 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06115967
Sponsor's protocol ID
D7130C00001
Status last verified
Nov 2025
First submitted
16 Oct 2023
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD6912 in people with Rheumatoid Arthritis, run by AstraZeneca at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) (time frame: From screening (Day -70) to last follow up visit (Day 197- approximately 38 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06115967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

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