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Healthy ParticipantsPhase 1NCT06072157

Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria

A Phase 1 study testing AK006-IV and AK006-SC in people with Healthy Participants and Chronic Spontaneous Urticaria, run by Allakos Inc. at 25 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 is a Phase 1, randomized, double-blind, placebo-controlled, sequential, single- and multiple-ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of intravenous (IV) infusions and a single subcutaneous (SC) injection of AK006. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
AK006-IV and AK006-SC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
25 sitesin 2 countries
Study dates
28 Aug 2023to 12 May 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • To be included in the study, the participant must:
  • Weigh between 60 and 120 kg (inclusive) and have a body mass index (BMI) between 20 and 32 kg/m2, inclusive
  • Agree (female of childbearing potential or male with female partner of childbearing potential) to use a highly effective method (<1% failure rate) of birth control, if sexually active from screening and for 16 weeks after the last dose of investigational product (IP).
  • Additionally, to be included in Part A, B and D, the participant must:
  • Be in good general health with no significant medical history and has no clinically significant abnormalities on physical examination
  • Additionally, to be included in Part C, the participant must:
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  • Have a diagnosis of chronic spontaneous urticaria (CSU) for at least 6 months prior to screening
  • Has a diagnosis of moderate to severe CSU that is refractory to stable doses of a single 2nd or later generation H1-AH between 1× and 4× the licensed dose and frequency at the time of randomization as defined by the following:
  • Presence of hives and itch for ≥6 consecutive weeks at any time prior to the Screening, despite the use of non-sedating H1-AHs. Note: Subject must be on a non-sedating H1-AH for treatment of CSU symptoms at the time of the Screening visit.
  • UAS7 score ≥16 with a HSS7 score ≥8 for the 2 consecutive weeks prior to randomization (Day 1) while on the stable dose of an H1-AH.
  • Be on a stable dose of a single 2nd or later generation H1-antihistamines for the treatment of CSU, between 1× and 4× the licensed dose and frequency, by Day -14 of the Screening Period and must be willing to remain on the same stable dose throughout the study.
  • Able and willing to complete a daily electronic diary to collect CSU symptoms for the duration of the study.

Who cannot join

  • A participant who meets any of the following exclusion criteria will not be eligible for inclusion in the study:
  • Female participants who are pregnant, lactating, or planning to become pregnant during the study.
  • Abnormal laboratory values, or findings in physical examination, ECG (QTc >450 ms for males and >470 ms for females), or vital signs considered to be clinically significant by the investigator.
  • Additionally, a participant will be excluded from Part A, B and D, if:
  • Received treatment with any prescribed (excluding hormonal contraceptives or hormone replacement therapy [post-menopausal females]) or nonprescribed systemic or topical medication (including herbal product, and vitamins) within 21 days prior to the first dose of IP (excluding acetaminophen).
  • Additionally, a participant will be excluded from Part C, if:
Show all 10Show fewer
  • Has known or suspected urticarial vasculitis
  • Subject has causes other than CSU for their urticaria including symptomatic dermographism, cholinergic urticaria, or any inducible urticaria
  • Subject has other conditions or diseases that in the investigator's opinion might influence study evaluations and results
  • Has any disease or condition (medical or surgical) which, in the opinion of the investigator, or medical monitor, would place the subject at increased risk

Trial locations and contacts

25 sites in 2 countries.

25 sites in 2 countries

United States19 sites

  • Site 601-001 Healthy Volunteer Clinical Research Unit (Part A, B and D)

    Anniston, Alabama, 36207

  • Site 601-014 (Part C)

    Bakersfield, California, 93301

  • Site 601-003 (Part C)

    Baltimore, Maryland, 21224

  • Site 601-004 (Part C)

    Birmingham, Alabama, 35209

  • Site 601-012 (Part C)

    Boston, Massachusetts, 02111

  • Site 601-020 (Part C)

    Brooklyn, New York, 11203

  • Site 601-002 (Part C)

    Cincinnati, Ohio, 45236

  • Site 601-016 (Part C)

    Colorado Springs, Colorado, 80907

  • Site 601-010 (Part C)

    El Paso, Texas, 79912

  • Site 601-007 (Part C)

    Encino, California, 91436

  • Site 601-017 (Part C)

    Fargo, North Dakota, 58103

  • Site 601-013 (Part C)

    Greenfield, Wisconsin, 53228

  • Site 601-019 (Part C)

    Lexington, Kentucky, 40509

  • Site 601-006 (Part C)

    Overland Park, Kansas, 66211

  • Site 601-018 (Part C)

    Portland, Oregon, 97201

  • Site 601-008 (Part C)

    Scottsdale, Arizona, 85251

  • Site 601-011 (Part C)

    St Louis, Missouri, 63141

  • Site 601-023 (Part C)

    Troy, Michigan, 48084

  • Site 601-015 (Part C)

    Upland, California, 91786

Other trials in United States

Canada6 sites

  • Site 601-106 (Part C)

    Calgary, Alberta, T2M 1A6

  • Site 601-103 (Part C)

    London, Ontario, N6H 5L5

  • Site 601-107 (Part C)

    Niagara Falls, Ontario, L2H 1H5

  • Site 601-102 (Part C)

    Québec, Quebec, G1V 4W2

  • Site 601-105 (Part C)

    Québec, Quebec, G1W 4R4

  • Site 601-108 (Part C)

    Toronto, Ontario, M5G 1E2

Other trials in Canada

About this study

Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Sequential, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of AK006 in Healthy Subjects and in Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria

This is a Phase 1, randomized, double-blind, placebo-controlled, sequential, single- and multiple-ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of intravenous (IV) infusions and a single subcutaneous (SC) injection of AK006. The study will be conducted in 4 parts: a single-ascending dose part (Part A) in healthy participants, a multiple-ascending dose part (Part B) in healthy participants with an expanded cohort (Part C) in participants with chronic spontaneous urticaria (CSU), and a single ascending dose SC injection cohort (Part D) in healthy participants.

Being tested
AK006-IV, Placebo-IV, AK006-SC, Placebo-SC
Medical subject headings
Chronic Urticaria

What participants receive

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

  • AK006-IVDrug

    Intravenous infusion

  • Placebo-IVDrug

    Intravenous infusion

  • AK006-SCDrug

    Subcutaneous

  • Placebo-SCDrug

    Subcutaneous

Study groups in NCT06072157
Study groupRoleWhat they receive
Part A - Single Ascending Dose (SAD) Intravenous CohortsExperimentalPart A: Healthy adult participants will receive a single intravenous infusion of AK006 or matching placebo. The dose of AK006 will be increased per cohort. There will be up to 5 cohorts evaluated.
Receives: Drug: AK006-IV; Drug: Placebo-IV
Part B - Multiple Ascending Dose (MAD) Intravenous CohortsExperimentalPart B: Healthy adult participants will receive multiple intravenous infusions of AK006 or matching placebo. The dose of AK006 will be increased per cohort. There will be up to 3 cohorts evaluated.
Receives: Drug: AK006-IV; Drug: Placebo-IV
Part C - Multiple Dose Intravenous CohortExperimentalPart C: Adults with Chronic Spontaneous Urticaria will receive multiple intravenous infusions of AK006 or matching placebo.
Receives: Drug: AK006-IV; Drug: Placebo-IV
Part D - Single Ascending Dose (SAD) Subcutaneous CohortsExperimentalPart D: Healthy adult participants will receive a single subcutaneous injection of AK006 or matching placebo. The dose of AK006 will be increased per cohort. There will be up to 2 cohorts evaluated.
Receives: Drug: AK006-SC; Drug: Placebo-SC

What is being measured

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

  1. Incidence and severity of adverse events (AEs)

    AEs, serious AEs, and treatment emergent AEs (AE that starts after start of investigational product)

    Measured: Screening to Day 113 (Part A and D), Screening to Day 141 (Part B), and Screening to Day 197 (Part C)

  2. Incidence of AEs of special interest

    Infusion-related reactions, injection-related reactions, injection site reactions, anaphylaxis, and opportunistic infections

    Measured: Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B), and Day 1 to Day 197 (Part C)

  3. AEs leading to discontinuation

    AEs

    Measured: Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B), and Day 1 to Day 197 (Part C)

  4. Incidence of clinically significant abnormal laboratory values, electrocardiograms (ECGs), and vital signs

    Incidence of clinically significant abnormal laboratory values, electrocardiograms (ECGs), and vital signs

    Measured: Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B), and Day 1 to Day 197 (Part C)

Secondary outcomes (14)

  1. AK006 serum concentration at end of IV infusion

    AK006 Serum concentration (ng/mL) at end of infusion

    Measured: Day 1 (Part A) and Day 29 (Part B)

  2. AK006 area under the concentration-time curve (AUC) from time 0 to the time of last quantifiable concentration (AUC[0-last])

    AK006 AUC(0-last) (ng x h/mL)

    Measured: Day 1 to Day 113 (Part A and D) and Day 29 to Day 141 (Part B)

  3. AK006 AUC from time 0 extrapolated to infinity (AUC[0-inf])

    AK006 AUC(0-inf) (ng x h/mL)

    Measured: Day 1 to Day 113 (Part A and D)

  4. Total systemic clearance of AK006 after intravenous or subcutaneous dose (CL)

    AK006 CL (L/h/kg)

    Measured: Day 1 to Day 113 (Part A and D) and Day 1 to Day 141 (Part B)

  5. Systemic steady-state volume of distribution (Vss) of AK006

    AK006 Vss (mg/L)

    Measured: Day 1 to Day 113 (Part A and D) and Day 1 to Day 141 (Part B)

  6. AK006 Terminal elimination phase half-life (t1/2)

    AK006 t1/2 (hours)

    Measured: Day 1 to Day 113 (Part A and D) and Day 1 to Day 141 (Part B)

  7. Predose AK006 serum concentration (Ctrough, before the next dose) (Part B)

    AK006 Ctrough (ng/mL)

    Measured: Day 29 (pre-dose)

  8. AK006 AUC(0-last) after the second dose (Part B)

    AK006 AUC(0-last) (ng x h/mL)

    Measured: Day 29 to Day 141

  9. AK006 AUC over the dosing time interval (time 0 to 28 days) (AUC[tau]) (Part B)

    AK006 AUC(tau) (ng x h/mL)

    Measured: Day 1 to Day 28 with each dosing interval

  10. AK006 serum concentrations

    AK006 ng/mL

    Measured: Up to Day 141 (Part A, B, D); Up to Day 197 (Part C)

  11. AK006 absolute bioavailability subcutaneous injection

    Ratio of mean AUC(0-last) after subcutaneous injection to mean AUC(0-last) after intravenous administration adjusted for dose

    Measured: Day 1 to Day 113 (Part A and D)

  12. AK006 PK dose proportionality (Part A, B, D)

    Comparing dose-normalized Cmax and AUC (Part A, B, and D)

    Measured: Up to Day 141

  13. AK006 PK dose stationarity (Part B)

    Comparing AUCtau from last dose to AUCtau from first dose

    Measured: Up to Day 141

  14. AK006 Anti-drug Antibodies (ADAs)

    Number of participants with positive or negative AK006-ADAs

    Measured: Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B) and Day 1 to Day 197 (Part C)

Timeline

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

  1. First posted10 Oct 2023
  2. Study start28 Aug 2023
  3. Primary completion12 May 2025
  4. Study completion12 May 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
Model description
Single (Part A) and multiple (Part B) ascending IV dose study in healthy participants with a multiple dose expansion (Part C) in participants with chronic spontaneous urticaria. Single ascending (Part D) subcutaneous (SC) dose study in healthy participants
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06072157
Sponsor's protocol ID
AK006-001
Status last verified
Jun 2025
First submitted
9 Sep 2023
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • O'Sullivan JA, Youngblood BA, Schleimer RP, Bochner BS. Siglecs as potential targets of therapy in human mast cell- and/or eosinophil-associated diseases. Semin Immunol. 2023 Sep;69:101799. doi: 10.1016/j.smim.2023.101799. Epub 2023 Jul 4.

    PubMed 37413923

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AK006-IV and AK006-SC in people with Healthy Participants and Chronic Spontaneous Urticaria, run by Allakos Inc. at 25 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 12 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 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Canada. 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. 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?

Incidence and severity of adverse events (AEs) (time frame: Screening to Day 113 (Part A and D), Screening to Day 141 (Part B), and Screening to Day 197 (Part C)). The study lists 4 primary outcomes in all. 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 NCT06072157, which also lists 1 linked publication.

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 3 Jun 2025.

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