Single Ascending Dose Study of ANX105

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2023-06-19

Brief Summary

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This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Placebo-controlled single ascending dose study.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ANX105

Group Type EXPERIMENTAL

ANX105

Intervention Type BIOLOGICAL

Participants will receive single-ascending doses of ANX105 administered by IV infusion.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive matching placebo administered by IV infusion.

Interventions

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ANX105

Participants will receive single-ascending doses of ANX105 administered by IV infusion.

Intervention Type BIOLOGICAL

Placebo

Participants will receive matching placebo administered by IV infusion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
* Have been fully vaccinated with SARS-CoV-2 vaccination according to local guidelines within 14 days prior to Day -1.
* Documented history of vaccinations within 5 years or willing to undergo vaccinations prior to screening visit against encapsulated bacterial pathogens.

Exclusion Criteria

* Clinically significant infection within 30 days prior to Day -1 that required medical intervention.
* Significant allergies to humanized monoclonal antibodies.
* Use of immunosuppressants including high-dose systemic corticosteroids within 30 days prior to Day -1.
* Antinuclear antibodies (ANA) titer ≥1:160 (for either of the 2 ANA results a minimum of 2 weeks apart) at Screening.
* Have poor venous access limiting phlebotomy.
* Donation or loss of \> 500 milliliter whole blood within 30 days prior to Day 1 or donation of plasma within 14 days prior to Day -1.
* Hospitalization during the 4 weeks prior to Screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes