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Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers

NCT04415671 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-06

No results posted yet for this study

Summary

This is a first in human (FIH), multi-center, dose escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AD-214 when administered to healthy volunteers (HVs). The study in HVs will be a randomized, double blind, and placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) (Part B) study.

Conditions

Interventions

BIOLOGICAL

AD-214

AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis.

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • AdAlta Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-19
Primary Completion
2021-10-21
Completion
2022-02-08

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04415671 on ClinicalTrials.gov