First in Man Study to Evaluate Initial SafetyPhase 1NCT05318534
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
A Phase 1 study testing GL-0719 in people with First in Man Study to Evaluate Initial Safety, run by Gliknik Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- First in Man Study to Evaluate Initial Safety
- What is being tested?
- GL-0719
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2022to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female or male subjects 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 subjects 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 administration.
- The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.
- Female or male subjects who, at the time of screening, are at least 18 years of age with a total body weight of ≥ 50 kg.
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- 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 subjects 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 administration.
- 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.
Who cannot join
- History of any clinically significant (as determined by the investigator) cardiac, endocrine, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric, renal, or other major disease.
- 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 unacceptable risk as a participant in this study.
- 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 subjects 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.
- CAD secondary to infection or an autoimmune disorder.
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- 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. Subjects 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 subjects who received GL-0719 in this study in Cohort 8, who cannot be re-enrolled in Cohort 9 within 60 days after their last dose of GL-0719.
- Concurrent plasma exchange therapy.
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Fortrea Clinical Research Unit Ltd
Leeds, LS2 9LH
Jim Bush, MBChB, PhD, 01133013500
Jim Bush, MBChB, PhD
About this study
Official title: GL-0719 - A Phase 1, Double-blind, Placebo-controlled, Single Ascending Intravenous and Subcutaneous Injection Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and an Open-label Evaluation of Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease
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).
- Being tested
- GL-0719, Placebo
- Keywords
- complement-mediated diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GL-0719Drug
Administration route: intravenous infusion and subcutaneous injection
PlaceboDrug
Administration route: intravenous infusion and subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| GL-0719 | Experimental | Dose level cohorts randomized in a 3:1 ratio to GL-0719 or placebo treatment, respectively.
The study will comprise a single-dose, sequential-group design.
Single Ascending IV Dose Cohorts
* Cohort 1: 4 subjects
* Cohort 2: 8 subjects
* Cohort 3: 8 subjects
* Cohort 4: 8 subjects
* Cohort 5: 8 subjects
Subcutaneous Injection Cohort
* Cohort 6: 8 subjects
* Cohort 7: 8 subjects
* Cohort 8 (Patient Arm): Up to 6 subjects with Cold Agglutinin Disease (CAD); Placebo is not applicable.
* Cohort 9 (Patient Arm): Up to 12 subjects with Cold Agglutinin Disease (CAD); Placebo is not applicable. Receives: Drug: GL-0719 |
| Placebo | Placebo comparator | Dose level cohorts randomized in a 3:1 ratio to GL-0719 or placebo treatment, respectively.
The study will comprise a single-dose, sequential-group design.
Single Ascending IV Dose Cohorts
* Cohort 1: 4 subjects
* Cohort 2: 8 subjects
* Cohort 3: 8 subjects
* Cohort 4: 8 subjects
* Cohort 5: 8 subjects
Subcutaneous Injection Cohort
* Cohort 6: 8 subjects
* Cohort 7: 8 subjects Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Measured: Day 1 to Follow-up (Day 31±2)
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Measured: Screening (Days -42 to -15) to Follow-up (Day 31±2)
Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, physical examination and measurement of cytokines
Measured: Screening (Days -42 to -15) to Follow-up (Day 31±2)
Secondary outcomes (7)
Area Under the Concentration time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)
Measured: Day 1 to Follow-up (Day 31±2)
Area Under the Concentration time Curve from Time 0 to the Time of the Last (AUC0-tlast)
Measured: Day 1 to Follow-up (Day 31±2)
Maximum Observed Concentration (Cmax)
Measured: Day 1 to Follow-up (Day 31±2)
Time of the maximum observed concentration (tmax)
Measured: Day 1 to Follow-up (Day 31±2)
Apparent terminal elimination half-life (t1/2)
Measured: Day 1 to Follow-up (Day 31±2)
The degree of complement classical pathway inhibition in study subjects over time
Measured: Day 1 to Follow-up (Day 31±2)
Incidence of anti-drug antibodies
Measured: Day -1, Day 15±1 and Follow-up (Day 31±2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start8 Apr 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First in Man Study to Evaluate Initial SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gliknik Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Bush, MBChB, PhD, Principal investigator, Fortrea Clinical Research Unit Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318534
- Sponsor's protocol ID
- GL0719-01
- Other IDs
- 2021-004925-57
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GL-0719 - A Phase 1, Double-blind, Placebo-controlled, Single Ascending Intravenous and Subcutaneous Injection Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and an Open-label Evaluation of Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease
- ClinicalTrials.gov ID
- NCT05318534
- Acronym / sponsor ID
- GL0719-01
- Keywords
- complement-mediated diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Gliknik Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GL-0719 | Experimental | Drug: GL-0719Dose level cohorts randomized in a 3:1 ratio to GL-0719 or placebo treatment, respectively. The study will comprise a single-dose, sequential-group design. Single Ascending IV Dose Cohorts * Cohort 1: 4 subjects * Cohort 2: 8 subjects * Cohort 3: 8 subjects * Cohort 4: 8 subjects * Cohort 5: 8 subjects Subcutaneous Injection Cohort * Cohort 6: 8 subjects * Cohort 7: 8 subjects * Cohort 8 (Patient Arm): Up to 6 subjects with Cold Agglutinin Disease (CAD); Placebo is not applicable. * Cohort 9 (Patient Arm): Up to 12 subjects with Cold Agglutinin Disease (CAD); Placebo is not applicable. |
| Placebo | Placebo comparator | Drug: PlaceboDose level cohorts randomized in a 3:1 ratio to GL-0719 or placebo treatment, respectively. The study will comprise a single-dose, sequential-group design. Single Ascending IV Dose Cohorts * Cohort 1: 4 subjects * Cohort 2: 8 subjects * Cohort 3: 8 subjects * Cohort 4: 8 subjects * Cohort 5: 8 subjects Subcutaneous Injection Cohort * Cohort 6: 8 subjects * Cohort 7: 8 subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy female or male subjects 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 subjects 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 administration.
- The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.
Key exclusion criteria (15 listed)
- History of any clinically significant (as determined by the investigator) cardiac, endocrine, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric, renal, or other major disease.
- 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 unacceptable risk as a participant in this study.
- 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 subjects 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GL-0719Administration route: intravenous infusion and subcutaneous injection | Drug | GL-0719 |
| PlaceboAdministration route: intravenous infusion and subcutaneous injection | Drug | Placebo |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Day 1 to Follow-up (Day 31±2)
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Time frame: Screening (Days -42 to -15) to Follow-up (Day 31±2)
Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, physical examination and measurement of cytokines
Time frame: Screening (Days -42 to -15) to Follow-up (Day 31±2)
7 secondary outcomes
Area Under the Concentration time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Day 1 to Follow-up (Day 31±2)
Area Under the Concentration time Curve from Time 0 to the Time of the Last (AUC0-tlast)
Time frame: Day 1 to Follow-up (Day 31±2)
Maximum Observed Concentration (Cmax)
Time frame: Day 1 to Follow-up (Day 31±2)
Time of the maximum observed concentration (tmax)
Time frame: Day 1 to Follow-up (Day 31±2)
Apparent terminal elimination half-life (t1/2)
Time frame: Day 1 to Follow-up (Day 31±2)
The degree of complement classical pathway inhibition in study subjects over time
Time frame: Day 1 to Follow-up (Day 31±2)
Incidence of anti-drug antibodies
Time frame: Day -1, Day 15±1 and Follow-up (Day 31±2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jim Bush, MBChB, PhD principal investigator
Fortrea Clinical Research Unit Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GL-0719 in people with First in Man Study to Evaluate Initial Safety, run by Gliknik Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gliknik Clinical Trials Group (410-665-0662, gliknikclinicaltrialinquiries@gliknik.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: Day 1 to Follow-up (Day 31±2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.