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NCT06072157 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With Chronic Spontaneous Urticaria
A Phase 1 study, sponsored by Allakos.
- Completed
- Registry status
- Phase 1
- Development phase
- 136
- Enrollment target
NCT06072157 is a Phase 1 study that has completed, run by Allakos. The registered enrollment target is 136 participants.
The verdict
NCT06072157, a Phase 1 study, has completed, sponsored by Allakos.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 136 participants
- Enrollment target
Study 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. 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.
Interventions
- DRUG Placebo-IV
- DRUG AK006-IV
- DRUG AK006-SC
- DRUG Placebo-SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2023-08-28 |
| Est. Completion | 2025-05-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06072157
The ClinicalTrials.gov registry entry for NCT06072157 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allakos, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo-IV is the first listed.
NCT06072157 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06072157 about?
NCT06072157 is a clinical study titled "Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects With 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 co...
What is the current status of trial NCT06072157?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2023-08-28. Estimated completion is 2025-05-12.
What interventions are being tested in trial NCT06072157?
The interventions under investigation include: Placebo-IV (DRUG), AK006-IV (DRUG), AK006-SC (DRUG), Placebo-SC (DRUG).
Who is sponsoring clinical trial NCT06072157?
This trial is sponsored by Allakos, which has 15 total clinical trials registered on ClinicalTrials.gov.
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