What is the mechanism of action of this treatment?

Common treatments in healthy subjects, such as vaccines and monoclonal antibodies, work by modulating the immune system. Vaccines stimulate the immune system to recognize and fight pathogens, while monoclonal antibodies target specific proteins or cells to alter immune responses. These mechanisms are important for healthy subjects to understand as they help predict the safety, efficacy, and potential side effects of new treatments like AK006, ensuring informed decision-making and monitoring during clinical trials.

What side effects are associated with this type of intervention?

Common side effects for treatments involving intravenous (IV) infusions and subcutaneous (SC) injections in healthy subjects typically include local reactions at the injection site (pain, redness, swelling), systemic reactions (fever, headache, fatigue), and potential allergic reactions. IV infusions may also cause vein irritation or phlebitis. Broader side effects observed in clinical trials can include gastrointestinal disturbances, dizziness, and mild to moderate infections.

What prior FDA approvals exist?

FDA approvals for treatments involving healthy subjects often focus on evaluating the safety, tolerability, pharmacokinetics, and immunogenicity of new drugs. These studies are crucial for understanding how a drug behaves in the human body before it is tested in patients with specific conditions. Examples of such drugs include various monoclonal antibodies and small molecule inhibitors, which undergo rigorous testing in healthy volunteers to assess their safety profile and biological effects. These studies help ensure that the drugs are safe for further clinical trials in patients with the targeted conditions.

What other types of research exist?

Promising novel alternatives to AK006 for healthy subjects in 2024 include: 1) MK-2206, a potent pan-AKT inhibitor, which is being evaluated for its safety and pharmacokinetic profiles in various cancers. 2) Selpercatinib, a selective RET inhibitor, showing efficacy in RET-altered thyroid cancers. 3) Futibatinib, an FGFR-selective tyrosine kinase inhibitor, recently approved for cholangiocarcinoma. These alternatives are in advanced stages of clinical trials or have received recent approvals, indicating their potential as novel treatments.

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Monoclonal Antibodies

AK006 for Chronic Urticaria

Phase 1

Recruiting

Research Sponsored by Allakos Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 (Part C only)

Have moderate to severe CSU that is refractory to stable doses of a single 2nd or later generation H1-antihistamines between 1× and 4× the licensed dose and frequency at the time of randomization as defined by the following (Part C Only): Presence of hives and itch for at least 6 consecutive weeks prior to the Screening Visit. Weekly urticaria activity score (UAS7) of at least 16 and weekly hive severity score (HSS7) of at least 8 for the 2 consecutive weeks prior to randomization (Day 1) while on the stable dose of an H1-antihistamines as described above (Note: participant must have completed at least 4 daily Urticaria Patient Daily Diary (UPDD) questionnaires during each of these qualifying weeks to remain eligible for study participation).

Must not have

Female participants who are pregnant, lactating, or planning to become pregnant during the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 113 (part a and d), day 1 to day 141 (part b) and day 1 to day 197 (part c)

Summary

This trial tests a new drug, AK006, given either directly into the bloodstream or just under the skin. It involves healthy people and those with chronic spontaneous urticaria, a condition with frequent hives. Researchers aim to see how the body handles the drug and if it causes any immune reactions.

Who is the study for?

This trial is for adults with chronic spontaneous urticaria (hives) unresponsive to antihistamines and healthy individuals within specific weight and BMI ranges. Participants must not be pregnant, planning pregnancy, or have significant medical issues. Men in the study must use contraception.

What is being tested?

The study tests AK006's safety and body response compared to a placebo in people with hives and healthy subjects. It involves single/multiple doses given through IV, exploring how the body processes the drug and its potential effectiveness.

What are the potential side effects?

As this is an early-phase trial for AK006, side effects are being assessed; however, common side effects may include reactions at the injection site, headaches, fatigue, allergic responses or other immune-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a stable dose of a specific allergy medication for my chronic hives.

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I have severe hives not better with usual allergy pills for over 6 weeks.

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I weigh between 60 and 120 kg and my BMI is between 20 and 32.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 113 (part a and d), day 1 to day 141 (part b) and day 1 to day 197 (part c)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 113 (part a and d), day 1 to day 141 (part b) and day 1 to day 197 (part c)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 113 (part a and d), day 1 to day 141 (part b) and day 1 to day 197 (part c) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AEs leading to discontinuation

Incidence and severity of adverse events (AEs)

Incidence of AEs of special interest

+1 more

Secondary study objectives

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

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

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

+11 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part D - Single Ascending Dose (SAD) Subcutaneous CohortsExperimental Treatment2 Interventions

Part 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.

Group II: Part C - Multiple Dose Intravenous CohortExperimental Treatment2 Interventions

Part C: Adults with Chronic Spontaneous Urticaria will receive multiple intravenous infusions of AK006 or matching placebo.

Group III: Part B - Multiple Ascending Dose (MAD) Intravenous CohortsExperimental Treatment2 Interventions

Part 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.

Group IV: Part A - Single Ascending Dose (SAD) Intravenous CohortsExperimental Treatment2 Interventions

Part 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo-IV

2013

Completed Phase 1

~70

Placebo-SC

2001

Completed Phase 4

~210

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments in healthy subjects, such as vaccines and monoclonal antibodies, work by modulating the immune system. Vaccines stimulate the immune system to recognize and fight pathogens, while monoclonal antibodies target specific proteins or cells to alter immune responses. These mechanisms are important for healthy subjects to understand as they help predict the safety, efficacy, and potential side effects of new treatments like AK006, ensuring informed decision-making and monitoring during clinical trials.

Fluoroquinolones in the management of tuberculous meningitis: Systematic review and meta-analysis.Cancer treatment-related neuropathic pain syndromes--epidemiology and treatment: an update.Frontline therapy in mantle cell lymphoma: the role of high-dose therapy and integration of new agents.