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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: Completed Phase 1 study, sponsored by Allakos.

NCT06072157 is a Phase 1 study that has completed, run by Allakos. The registered enrollment target is 136 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (127% higher). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

AEs, serious AEs, and treatment emergent AEs (AE that starts after start of investigational product)

Interventions

  • DRUG Placebo-IV
  • DRUG AK006-IV
  • DRUG AK006-SC
  • DRUG Placebo-SC

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2023-08-28
Est. Completion 2025-05-12
Phase Phase 1
Allakos

15 total trials

What the finished NCT06072157 record still lists

NCT06072157 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (127% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo-IV is the first listed.

NCT06072157 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT06072157's enrollment target sits among peer trials

136 422nd of 2000 higher than 1,576 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06072157, the US trial registry maintained by the National Library of Medicine. NCT06072157 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.