Pilot Study of AVT16 in Healthy Adult Subjects | NCT06400719

Studies
Pilot Study of AVT16 in Healthy Adult Subjects

NCT06400719

Sponsor

Alvotech Swiss AG

Status

Completed

Last Update Posted

Mar 11, 2025Actual

Enrollment

18Actual

Phase

Phase 1

Conditions

Healthy

Interventions

AVT16

Countries

New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2024Actual

Primary Completion Date

Nov 6, 2024Actual

Completion Date

Nov 6, 2024Actual

First Submitted Date

Apr 24, 2024

First Submission Date that Met QC Criteria

May 2, 2024

First Posted Date

May 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2025

Last Update Posted Date

Mar 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a pilot study in healthy adult subjects to evaluate the safety and tolerability of AVT16 after administration of a single intravenous administration. Pharmacokinetics and immunogenicity of AVT16 will also be evaluated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AVT16	Experimental	Single intravenous administration of 300mg AVT16, proposed biosimilar to vedolizumab	Biological: AVT16

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AVT16	Biological	Single intravenous administration of 300mg of AVT16	AVT16

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence, nature and severity of Treatment Emergent Adverse Events	Safety and Tolerability of AVT16	18 weeks

Secondary Outcomes

Measure	Description	Time Frame
Maximum Plasma Concentration (Cmax) of AVT16	Pharmacokinetic parameters	18 weeks
Frequency of anti-drug antibodies	Immunogenicity of AVT16

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female subjects aged between 18 and 55 years old inclusive
Medical history without evidence of clinically significant disorder, condition or disease that would pose a risk to subject safety
Haematology and biochemistry tests within normal range

Exclusion Criteria:

History of relevant drug and/or food allergies
History of hypersensitivity to vedolizumab, AVT16 of their constituents
Past or concurrent medical conditions that could potentially increase subject's risks or interfere with study evaluations

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CCST		Christchurch		8011	New Zealand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided