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A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers

NCT05723692 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-02-06

No results posted yet for this study

Summary

This study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of ALTB-268 in healthy volunteers.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

ALTB-268

monoclonal antibody

OTHER

Placebo

formulation buffer

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • AltruBio Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Dickerson, MD · ICON plc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-01-17
Primary Completion
2023-10-27
Completion
2023-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT05723692 on ClinicalTrials.gov