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Tests treatment safety and results for First in Man Study to Evaluate Initial Safety
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
ClinicalTrials.gov ID: NCT05318534
What this study is testing
What is GL-0719?
GL-0719 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for first in man study to evaluate initial safety.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- for Cohorts 1 to 7
- Healthy female or male people who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- Body mass index of 18.0 to 32.0 kg/m\^2, inclusive; and a total body weight \> 50 kg up to a maximum of 110 kg.
- Study people must have received a quadrivalent meningococcal conjugate vaccine (meningococcal serogroups A, C, W, and Y) within the past 5 years or...
You likely can't join if
- for Cohorts 1 to 7
- History of any clinically significant (as determined by the investigator) cardiac, endocrine, hematological, hepatic, immunological, metabolic...
- Evidence of clinically significant medical condition or other condition that might significantly interfere with the absorption, distribution...
- Signs and symptoms of, or diagnosis consistent with a chronic autoimmune disorder and/or positive antinuclear antibodies (ANA) test by indirect...
- Documented history of autoimmune disease, or history of a syndrome that required systemic steroids or immunosuppressive medications, except for...
- Any underlying medical condition that, in the opinion of the investigator, renders the subject a poor candidate for this study or could confound the...
See the full eligibility criteria
- for Cohorts 1 to 7
- Healthy female or male people who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- Body mass index of 18.0 to 32.0 kg/m\^2, inclusive; and a total body weight \> 50 kg up to a maximum of 110 kg.
- Study people must have received a quadrivalent meningococcal conjugate vaccine (meningococcal serogroups A, C, W, and Y) within the past 5 years or vaccination a minimum of 14 days prior to initial study drug...
- The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent. for Cohorts 8 to 9
- Female or male people who, at the time of screening, are at least 18 years of age with a total body weight of ≥ 50 kg.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.
- The subject must be willing to return to the study center for study treatment and study-related follow-up procedures as required by the protocol.
- Study people must have received a quadrivalent meningococcal conjugate vaccine (meningococcal serogroups A, C, W, and Y) within the past 5 years or vaccination a minimum of 14 days prior to initial study drug...
- The Participant Identification Center (PIC) site will have provided evidence that the PIC site used to confirm diagnosis of Cold Agglutinin Disease (CAD)
- Primary Cold Agglutinin Disease (CAD) or CAD secondary to active lymphoid or other hematologic malignancy (Cold Agglutinin Syndrome).
- Hemoglobin level \< 105 gram per liter (g/L).
- Bilirubin level above the normal reference range. Key
- for Cohorts 1 to 7
- History of any clinically significant (as determined by the investigator) cardiac, endocrine, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric, renal, or...
- Evidence of clinically significant medical condition or other condition that might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an...
- Signs and symptoms of, or diagnosis consistent with a chronic autoimmune disorder and/or positive antinuclear antibodies (ANA) test by indirect immunofluorescence confirmed by ANA titer ≥ 1:160.
- Documented history of autoimmune disease, or history of a syndrome that required systemic steroids or immunosuppressive medications, except for people with vitiligo or resolved childhood asthma/atopy.
- Any underlying medical condition that, in the opinion of the investigator, renders the subject a poor candidate for this study or could confound the results of the study or put the subject at undue risk. Key Exclusion...
- CAD secondary to infection or an autoimmune disorder.
- CAD secondary to active lymphoid or other hematologic malignancy not meeting the inclusion criteria.
- Diagnosis of any other malignancy except for adequately treated basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the subject has been disease-free for ≥ 5 years.
- Clinically relevant infection of any kind within the month preceding enrollment (example, active hepatitis C, pneumonia).
- Clinical diagnosis of Systemic Lupus Erythematosus (SLE), other autoimmune disorders, or ANA titer \> 1:160 at Screening.
- Positive hepatitis panel and/or positive HIV (Human Immuno Deficiency) test. people whose results are compatible with prior immunization may be included at the discretion of the investigator.
- Positive HIV antibody at Screening.
- Treatment with an investigational drug within 90 days or five half-lives preceding the first dose of IP (whichever is longer), with the exception of people who received GL-0719 in this study in Cohort 8, who cannot be...
- Concurrent plasma exchange therapy. Other protocol defined inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Leeds, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leeds, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.