A Phase 1 interventional study of AK006-IV and Placebo-IV in Healthy Participants and Chronic Spontaneous Urticaria, sponsored by Allakos Inc.. Completed at 25 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by Allakos Inc. · Phase 1, Interventional, and Treatment
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.
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
This study's enrollment of 136 is above the median of 80 across 145 interventional studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →Allakos Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 9 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
To be included in the study, the participant must:
Additionally, to be included in Part A, B and D, the participant must:
Additionally, to be included in Part C, the participant must:
Has a diagnosis of moderate to severe CSU that is 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:
Key Exclusion Criteria:
A participant who meets any of the following exclusion criteria will not be eligible for inclusion in the study:
Additionally, a participant will be excluded from Part A, B and D, if:
Additionally, a participant will be excluded from Part C, if:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: AK006-IV · Drug: Placebo-IV
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.
Drug: AK006-IV · Drug: Placebo-IV
Part C: Adults with Chronic Spontaneous Urticaria will receive multiple intravenous infusions of AK006 or matching placebo.
Drug: AK006-IV · Drug: Placebo-IV
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.
Drug: AK006-SC · Drug: Placebo-SC
Intravenous infusion
Intravenous infusion
Subcutaneous
Subcutaneous
Incidence and severity of adverse events (AEs)
AEs, serious AEs, and treatment emergent AEs (AE that starts after start of investigational product)
Time frame: Screening to Day 113 (Part A and D), Screening to Day 141 (Part B), and Screening to Day 197 (Part C)
Incidence of AEs of special interest
Infusion-related reactions, injection-related reactions, injection site reactions, anaphylaxis, and opportunistic infections
Time frame: Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B), and Day 1 to Day 197 (Part C)
AEs leading to discontinuation
AEs
Time frame: Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B), and Day 1 to Day 197 (Part C)
Incidence of clinically significant abnormal laboratory values, electrocardiograms (ECGs), and vital signs
Incidence of clinically significant abnormal laboratory values, electrocardiograms (ECGs), and vital signs
Time frame: Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B), and Day 1 to Day 197 (Part C)
AK006 serum concentration at end of IV infusion
AK006 Serum concentration (ng/mL) at end of infusion
Time frame: Day 1 (Part A) and Day 29 (Part B)
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)
Time frame: Day 1 to Day 113 (Part A and D) and Day 29 to Day 141 (Part B)
AK006 AUC from time 0 extrapolated to infinity (AUC[0-inf])
AK006 AUC(0-inf) (ng x h/mL)
Time frame: Day 1 to Day 113 (Part A and D)
Total systemic clearance of AK006 after intravenous or subcutaneous dose (CL)
AK006 CL (L/h/kg)
Time frame: Day 1 to Day 113 (Part A and D) and Day 1 to Day 141 (Part B)
Systemic steady-state volume of distribution (Vss) of AK006
AK006 Vss (mg/L)
Time frame: Day 1 to Day 113 (Part A and D) and Day 1 to Day 141 (Part B)
AK006 Terminal elimination phase half-life (t1/2)
AK006 t1/2 (hours)
Time frame: Day 1 to Day 113 (Part A and D) and Day 1 to Day 141 (Part B)
Predose AK006 serum concentration (Ctrough, before the next dose) (Part B)
AK006 Ctrough (ng/mL)
Time frame: Day 29 (pre-dose)
AK006 AUC(0-last) after the second dose (Part B)
AK006 AUC(0-last) (ng x h/mL)
Time frame: Day 29 to Day 141
AK006 AUC over the dosing time interval (time 0 to 28 days) (AUC[tau]) (Part B)
AK006 AUC(tau) (ng x h/mL)
Time frame: Day 1 to Day 28 with each dosing interval
AK006 serum concentrations
AK006 ng/mL
Time frame: Up to Day 141 (Part A, B, D); Up to Day 197 (Part C)
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
Time frame: Day 1 to Day 113 (Part A and D)
AK006 PK dose proportionality (Part A, B, D)
Comparing dose-normalized Cmax and AUC (Part A, B, and D)
Time frame: Up to Day 141
AK006 PK dose stationarity (Part B)
Comparing AUCtau from last dose to AUCtau from first dose
Time frame: Up to Day 141
AK006 Anti-drug Antibodies (ADAs)
Number of participants with positive or negative AK006-ADAs
Time frame: Day 1 to Day 113 (Part A and D), Day 1 to Day 141 (Part B) and Day 1 to Day 197 (Part C)
Plan to share: No
Ran from Aug 2023 to primary completion in May 2025, 20 months.
Of 15 phase 1 interventional studies under Chronic Urticaria, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 21. This study's 20 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Allakos Inc.