Actively Recruiting
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
Led by Gliknik Inc. · Updated on 2026-03-06
70
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female adults aged 18 to 65 years for cohorts 1 to 7
- Females not pregnant or lactating; all participants agree to use contraception if applicable
- Body mass index between 18.0 and 32.0 kg/m²; body weight over 50 kg up to 110 kg
- Received quadrivalent meningococcal conjugate vaccine within past 5 years or at least 14 days before dosing
- Able to understand study risks and provide informed consent
- For cohorts 8 to 9, adults aged 18 or older with body weight at least 50 kg
- Willing to return for treatment and follow-up visits as required
- Diagnosed with primary or secondary cold agglutinin disease
- Hemoglobin level less than 105 g/L
- Elevated bilirubin levels above normal range
You will not qualify if you...
- History of significant cardiac, endocrine, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric, renal, or other major diseases
- Any medical condition that could interfere with study drug processing or increase risk
- Signs or diagnosis of chronic autoimmune disorders or positive ANA test with titer ≥ 1:160
- History of autoimmune disease or systemic steroid/immunosuppressive treatment, except vitiligo or resolved childhood asthma/atopy
- Cold agglutinin disease secondary to infection or autoimmune disorder
- Cold agglutinin disease secondary to active malignancy not meeting criteria
- Diagnosis of any other malignancy except certain treated skin cancers or disease-free for 5 years
- Recent clinically relevant infections within one month prior to enrollment
- Clinical diagnosis of systemic lupus erythematosus or other autoimmune disorders
- Positive hepatitis or HIV test, unless due to prior immunization
- Treatment with investigational drugs within 90 days or five half-lives before first dose
- Concurrent plasma exchange therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fortrea Clinical Research Unit Ltd
Leeds, United Kingdom, LS2 9LH
Actively Recruiting
Research Team
G
Gliknik Clinical Trials Group
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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