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Pilot Study of AVT16 in Healthy Adult Subjects - Trial NCT06400719

Access comprehensive clinical trial information for NCT06400719 through Pure Global AI's free database. This Phase 1 trial is sponsored by Alvotech Swiss AG and is currently Not yet recruiting. The study focuses on Healthy. Target enrollment is 18 participants.

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NCT06400719
Phase 1
Not yet recruiting
biological
Trial Details
ClinicalTrials.gov • NCT06400719
View on ClinicalTrials.gov
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Pilot Study of AVT16 in Healthy Adult Subjects
An Open Label, Single Arm Pilot Study to Investigate the Safety and Tolerability of a Single 300mg Intravenous Dose of AVT16 in Healthy Adult Subjects Aged 18 to 55 Years Inclusive

Study Focus

Healthy

AVT16

Interventional

biological

Sponsor & Location

Alvotech Swiss AG

Christchurch, New Zealand

Timeline & Enrollment

Phase 1

May 15, 2024

Oct 16, 2024

18 participants

Primary Outcome

Incidence, nature and severity of Treatment Emergent Adverse Events

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.

ICD-10 Classifications

Obesity
Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmful
Healthy person accompanying sick person
Lifestyle-related condition
Malnutrition

Data Source

ClinicalTrials.gov

NCT06400719

Non-Device Trial