Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria
Public ClinicalTrials.gov record NCT06072157. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06072157
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 136 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 28, 2023 (Actual)
- Primary completion
- May 12, 2025 (Actual)
- Completion
- May 12, 2025 (Actual)
- Last update posted
- Jun 3, 2025
2023 – 2025
United States locations
- U.S. sites
- 19
- U.S. states
- 16
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 601-001 Healthy Volunteer Clinical Research Unit (Part A, B and D) | Anniston | Alabama | 36207 | — |
| Site 601-004 (Part C) | Birmingham | Alabama | 35209 | — |
| Site 601-008 (Part C) | Scottsdale | Arizona | 85251 | — |
| Site 601-014 (Part C) | Bakersfield | California | 93301 | — |
| Site 601-007 (Part C) | Encino | California | 91436 | — |
| Site 601-015 (Part C) | Upland | California | 91786 | — |
| Site 601-016 (Part C) | Colorado Springs | Colorado | 80907 | — |
| Site 601-006 (Part C) | Overland Park | Kansas | 66211 | — |
| Site 601-019 (Part C) | Lexington | Kentucky | 40509 | — |
| Site 601-003 (Part C) | Baltimore | Maryland | 21224 | — |
| Site 601-012 (Part C) | Boston | Massachusetts | 02111 | — |
| Site 601-023 (Part C) | Troy | Michigan | 48084 | — |
| Site 601-011 (Part C) | St Louis | Missouri | 63141 | — |
| Site 601-020 (Part C) | Brooklyn | New York | 11203 | — |
| Site 601-017 (Part C) | Fargo | North Dakota | 58103 | — |
| Site 601-002 (Part C) | Cincinnati | Ohio | 45236 | — |
| Site 601-018 (Part C) | Portland | Oregon | 97201 | — |
| Site 601-010 (Part C) | El Paso | Texas | 79912 | — |
| Site 601-013 (Part C) | Greenfield | Wisconsin | 53228 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06072157, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 3, 2025 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06072157 live on ClinicalTrials.gov.