Study Conducted in Healthy VolunteersPhase 1NCT04324268
A Study to Evaluate Safety, Tolerability, and Bioavailability of Subcutaneous Lirentelimab (AK002) in Adult Healthy Volunteers
A Phase 1 study testing lirentelimab (AK002) in people with Study Conducted in Healthy Volunteers, run by Allakos Inc. at 1 site in United States.
Trial summary
This is a Phase 1, single-center study to evaluate safety, tolerability, and bioavailability of subcutaneously administered lirentelimab (AK002) in adult healthy volunteers. Subjects will receive a single dose of intravenous AK002 or subcutaneous lirentelimab (AK002) assigned in a double-blind, randomized fashion. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Study Conducted in Healthy Volunteers
- What is being tested?
- lirentelimab (AK002)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2020to 10 Feb 2021
- 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
- Provided written informed consent.
- Male or female aged ≥18 and ≤65 years at the time of signing the ICF.
- Determined by the Investigator to be in good health as documented by medical history, vital signs, physical examination, laboratory assessments, ECG, and by general observations.
- Subjects must weigh at least 50 kg and have a BMI between 18 g/m2 and 30 kg/m2, inclusive.
- Negative urine drug screen at Screening.
- Subjects must have the ability and willingness to attend the necessary visits to the study center and the ability to communicate effectively with the study site personnel.
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- Negative screening ova and parasite test.
- Female subjects must be either post-menopausal for at least 1 year with FSH level >40 IU/mL at Screening or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from Screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
- Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from Screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
Who cannot join
- Peripheral blood absolute eosinophil count >300/µL.
- Known hypersensitivity to any constituent of the study drug.
- Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Presence of abnormal laboratory values considered to be clinically significant by the Investigator.
- Any disease of condition (medical or surgical) which, in the opinion of the Investigator, would place the subject at increased risk.
- History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer, or non-melanoma skin cancers.
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- Treatment with chemotherapy or radiotherapy in the preceding 6 months.
- Treatment for a helminthic parasitic infection within 6 months of screening.
- Use during the 30 days before Screening (or 5 half-lives, whichever is longer) or use during the Screening period of omalizumab, dupilumab, systemic immunosuppressive drugs, or systemic corticosteroids, except if receiving as part of a premedication protocol.
- Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration.
- Positive hepatitis serology results, except for vaccinated subjects or subjects with past but resolved hepatitis, at Screening.
- Positive HIV serology results at Screening.
- Alcohol, drug, or other substance abuse or dependence.
- Any other reason that, in the opinion of the Investigator or Medical Monitor, makes the subject unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Allakos Investigational Site
Edgewater, Florida, 32132
About this study
Official title: A Phase 1 Study to Evaluate Safety, Tolerability, and Bioavailability of Subcutaneously Administered Lirentelimab (AK002) in Adult Healthy Volunteers
This is a Phase 1, single-center study to evaluate safety, tolerability, and bioavailability of subcutaneously administered lirentelimab (AK002) in adult healthy volunteers. Subjects will receive a single dose of intravenous AK002 or subcutaneous lirentelimab (AK002) assigned in a double-blind, randomized fashion.
- Conditions
- Study Conducted in Healthy Volunteers
- Being tested
- lirentelimab (AK002), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lirentelimab (AK002)Drug
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
| SC 0.3 mg/kg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 0.3 mg/kg of lirentelimab (AK002) administered subcutaneously. Receives: Drug: lirentelimab (AK002) |
| SC 1 mg/kg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 1 mg/kg of lirentelimab (AK002) administered subcutaneously. Receives: Drug: lirentelimab (AK002) |
| SC 3 mg/kg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 3 mg/kg of lirentelimab (AK002) administered subcutaneously. Receives: Drug: lirentelimab (AK002) |
| SC 5 mg/kg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 5 mg/kg of lirentelimab (AK002) administered subcutaneously. Receives: Drug: lirentelimab (AK002) |
| IV 1 mg/kg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 1 mg/kg of lirentelimab (AK002) administered intravenously. Receives: Drug: lirentelimab (AK002) |
| IV 3 mg/kg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 3 mg/kg of lirentelimab (AK002) administered intravenously. Receives: Drug: lirentelimab (AK002) |
| IV 3 mg/kg of lirentelimab (AK002) (Priming) | Experimental | Subjects in this arm will receive a single dose of 3 mg/kg of lirentelimab (AK002) administered intravenously from an IV bag prepared with extra volume for priming IV set. Receives: Drug: lirentelimab (AK002) |
| SC 300 mg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a single dose of 300 mg of lirentelimab (AK002) administered subcutaneously. Receives: Drug: lirentelimab (AK002) |
| SC 450 mg of lirentelimab (AK002) | Experimental | Subjects in this arm will receive a total of 450 mg of lirentelimab (AK002), administered as two separate subcutaneous injections. Receives: Drug: lirentelimab (AK002) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of lirentelimab (AK002) administered subcutaneously by evaluating adverse events assessed using the CTCAE version 5
Measured: Day 0 (baseline) to Day 85
Pharmacokinetics, including bioavailability, of lirentelimab (AK002) administered subcutaneously
Measured: Day 0 (baseline) to Day 85
Secondary outcomes (2)
Pharmacodynamics of lirentelimab (AK002) SC formulation as measured by changes in absolute peripheral blood counts of esoinophils
Measured: Day 0 (baseline) to Day 85
Bioavailability of lirentelimab (AK002) SC formulation relative to lirentelimab (AK002) IV by analyzing the area under the serum AUC
Measured: Day 0 (baseline) to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start23 Mar 2020
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study Conducted in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allakos Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henrik Rasmussen, MD, PhD, Study director, Allakos Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324268
- Sponsor's protocol ID
- AK002-017
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate Safety, Tolerability, and Bioavailability of Subcutaneously Administered Lirentelimab (AK002) in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04324268
- Acronym / sponsor ID
- AK002-017
- Conditions
- Study Conducted in Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Allakos Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, single-center study to evaluate safety, tolerability, and bioavailability of subcutaneously administered lirentelimab (AK002) in adult healthy volunteers. Subjects will receive a single dose of intravenous AK002 or subcutaneous lirentelimab (AK002) assigned in a double-blind, randomized fashion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
| SC 0.3 mg/kg of lirentelimab (AK002) | Experimental | Drug: lirentelimab (AK002)Subjects in this arm will receive a single dose of 0.3 mg/kg of lirentelimab (AK002) administered subcutaneously. |
| SC 1 mg/kg of lirentelimab (AK002) | Experimental | Drug: lirentelimab (AK002)Subjects in this arm will receive a single dose of 1 mg/kg of lirentelimab (AK002) administered subcutaneously. |
| SC 3 mg/kg of lirentelimab (AK002) | Experimental | Drug: lirentelimab (AK002)Subjects in this arm will receive a single dose of 3 mg/kg of lirentelimab (AK002) administered subcutaneously. |
| SC 5 mg/kg of lirentelimab (AK002) | Experimental | Drug: lirentelimab (AK002)Subjects in this arm will receive a single dose of 5 mg/kg of lirentelimab (AK002) administered subcutaneously. |
| IV 1 mg/kg of lirentelimab (AK002) | Experimental | Drug: lirentelimab (AK002)Subjects in this arm will receive a single dose of 1 mg/kg of lirentelimab (AK002) administered intravenously. |
| IV 3 mg/kg of lirentelimab (AK002) | Experimental | Drug: lirentelimab (AK002)Subjects in this arm will receive a single dose of 3 mg/kg of lirentelimab (AK002) administered intravenously. |
| IV 3 mg/kg of lirentelimab (AK002) (Priming) | Experimental | Drug: lirentelimab (AK002)Subjects in this arm will receive a single dose of 3 mg/kg of lirentelimab (AK002) administered intravenously from an IV bag prepared with extra volume for priming IV set. |
| SC 300 mg of lirentelimab (AK002) | Experimental | Drug: lirentelimab (AK002)Subjects in this arm will receive a single dose of 300 mg of lirentelimab (AK002) administered subcutaneously. |
| SC 450 mg of lirentelimab (AK002) | Experimental | Drug: lirentelimab (AK002)Subjects in this arm will receive a total of 450 mg of lirentelimab (AK002), administered as two separate subcutaneous injections. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provided written informed consent.
- Male or female aged ≥18 and ≤65 years at the time of signing the ICF.
- Determined by the Investigator to be in good health as documented by medical history, vital signs, physical examination, laboratory assessments, ECG, and by general observations.
- Subjects must weigh at least 50 kg and have a BMI between 18 g/m2 and 30 kg/m2, inclusive.
- Negative urine drug screen at Screening.
Key exclusion criteria (14 listed)
- Peripheral blood absolute eosinophil count >300/µL.
- Known hypersensitivity to any constituent of the study drug.
- Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Presence of abnormal laboratory values considered to be clinically significant by the Investigator.
- Any disease of condition (medical or surgical) which, in the opinion of the Investigator, would place the subject at increased risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lirentelimab (AK002)Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. | Drug | IV 1 mg/kg of lirentelimab (AK002), IV 3 mg/kg of lirentelimab (AK002), IV 3 mg/kg of lirentelimab (AK002) (Priming), SC 0.3 mg/kg of lirentelimab (AK002), SC 1 mg/kg of lirentelimab (AK002), SC 3 mg/kg of lirentelimab (AK002), SC 300 mg of lirentelimab (AK002), SC 450 mg of lirentelimab (AK002), SC 5 mg/kg of lirentelimab (AK002) |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Safety and tolerability of lirentelimab (AK002) administered subcutaneously by evaluating adverse events assessed using the CTCAE version 5
Time frame: Day 0 (baseline) to Day 85
Pharmacokinetics, including bioavailability, of lirentelimab (AK002) administered subcutaneously
Time frame: Day 0 (baseline) to Day 85
2 secondary outcomes
Pharmacodynamics of lirentelimab (AK002) SC formulation as measured by changes in absolute peripheral blood counts of esoinophils
Time frame: Day 0 (baseline) to Day 85
Bioavailability of lirentelimab (AK002) SC formulation relative to lirentelimab (AK002) IV by analyzing the area under the serum AUC
Time frame: Day 0 (baseline) to Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Rasmussen, MD, PhD study director
Allakos Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lirentelimab (AK002) in people with Study Conducted in Healthy Volunteers, run by Allakos Inc. at 1 site in United States.
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 9 inclusion and 14 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Safety and tolerability of lirentelimab (AK002) administered subcutaneously by evaluating adverse events assessed using the CTCAE version 5 (time frame: Day 0 (baseline) to Day 85). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.