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Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease

NCT05318534 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-03-06

No results posted yet for this study

Summary

The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GL-0719 following single intravenous (IV) and subcutaneous injection (SC) doses in healthy adult male and female subjects.

In addition, safety, tolerability, PK, and pilot efficacy biomarkers will be evaluated in subjects with cold agglutinin disease (CAD).

Conditions

  • First in Man Study to Evaluate Initial Safety

Interventions

DRUG

GL-0719

Administration route: intravenous infusion and subcutaneous injection

DRUG

Placebo

Administration route: intravenous infusion and subcutaneous injection

Sponsors & Collaborators

  • Gliknik Inc.

    lead INDUSTRY

Principal Investigators

  • Jim Bush, MBChB, PhD · Fortrea Clinical Research Unit Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-08
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT05318534 on ClinicalTrials.gov