[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"first-in-man-study-to-evaluate-initial-safety\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:first-in-man-study-to-evaluate-initial-safety":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100648450","early-phase-1-a-single-and-multiple-ascending-dose-trial-assessing-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-zp6590-in-participants-with-normal-weight-overweight-and-obesity-100648450",false,"NCT07721597","A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity","A First-in-human, Randomized, Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity","Inclusion Criteria:\n\nSAD-Part:\n\n* Male participant\n* Age between 18 and 55 years, both inclusive\n* Body Mass Index (BMI) between 20.0 and 29.9 kg\u002Fm\\^2, both inclusive\n\nMAD-Part:\n\n* Male participant\n* Age between 18 and 60 years, both inclusive\n* Body Mass Index (BMI) between 27.0 and 39.9 kg\u002Fm\\^2, both inclusive\n\nExclusion Criteria:\n\nSAD-Part and MAD-Part:\n\n* Any clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, as judged by the investigator\n* Treatment for weight management within 3 months before randomization in this trial",true,"MALE","18 Years","60 Years",{"count":21,"type":22},88,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","The goal of this clinical trial is to learn about the safety and tolerability of drug ZP6590 and to learn how the body processes the drug ZP6590 in adults. The main questions it aims to answer are:\n\n* Is the drug ZP6590 safe and well tolerated when administered as escalating single and multiple doses of the ZP6590?\n* How quickly and to what extent the administered investigational drug is absorbed and distributed, and how long it takes to be eliminated from the body?\n\nIn the first Part of the study:\n\nParticipants will:\n\n• Get a single ascending dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.\n\nIn the second Part of the study:\n\nParticipants will:\n\n• Get multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.",[28,29,30],"Healthy Participants Study","Overweight and Obese Adults","First in Man Study to Evaluate Initial Safety",[32,33,34,35],"ZP6590","Safety and Tolerability","GIP-R agonist","obesity","RECRUITING","2026-08-12",{"date":39,"type":40},"2026-08-13","ACTUAL",{"date":42,"type":40},"2026-07-09",{"date":44,"type":22},"2027-09-06",{"name":46,"class":47},"Zealand Pharma","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":16,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":48},"100463733","phase-1-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-100463733","NCT05318534","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","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","Inclusion Criteria for Cohorts 1 to 7\n\n1. Healthy female or male subjects who, at the time of screening, are between the ages of 18 and 65 years, inclusive.\n2. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.\n3. Body mass index of 18.0 to 32.0 kg\u002Fm\\^2, inclusive; and a total body weight \\> 50 kg up to a maximum of 110 kg.\n4. 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.\n5. The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.\n\nInclusion Criteria for Cohorts 8 to 9\n\n1. 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.\n2. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.\n3. The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.\n4. 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.\n5. 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.\n6. The Participant Identification Center (PIC) site will have provided evidence that the PIC site used to confirm diagnosis of Cold Agglutinin Disease (CAD)\n7. Primary Cold Agglutinin Disease (CAD) or CAD secondary to active lymphoid or other hematologic malignancy (Cold Agglutinin Syndrome).\n8. Hemoglobin level \\\u003C 105 gram per liter (g\u002FL).\n9. Bilirubin level above the normal reference range.\n\nKey Exclusion Criteria for Cohorts 1 to 7\n\n1. 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.\n2. 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.\n3. Signs and symptoms of, or diagnosis consistent with a chronic autoimmune disorder and\u002For positive antinuclear antibodies (ANA) test by indirect immunofluorescence confirmed by ANA titer ≥ 1:160.\n4. 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\u002Fatopy.\n5. 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.\n\nKey Exclusion Criteria for Cohorts 8 to 9\n\n1. CAD secondary to infection or an autoimmune disorder.\n2. CAD secondary to active lymphoid or other hematologic malignancy not meeting the inclusion criteria.\n3. 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.\n4. Clinically relevant infection of any kind within the month preceding enrollment (example, active hepatitis C, pneumonia).\n5. Clinical diagnosis of Systemic Lupus Erythematosus (SLE), other autoimmune disorders, or ANA titer \\> 1:160 at Screening.\n6. Positive hepatitis panel and\u002For positive HIV (Human Immuno Deficiency) test. Subjects whose results are compatible with prior immunization may be included at the discretion of the investigator.\n7. Positive HIV antibody at Screening.\n8. 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.\n9. Concurrent plasma exchange therapy.\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.","ALL",{"count":58,"type":22},70,[60],"PHASE1","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.\n\nIn addition, safety, tolerability, PK, and pilot efficacy biomarkers will be evaluated in subjects with cold agglutinin disease (CAD).",[30],[64],"complement-mediated diseases","2026-03-04",{"date":67,"type":40},"2026-03-06",{"date":69,"type":40},"2022-04-08",{"date":71,"type":22},"2026-06-30",{"name":73,"class":47},"Gliknik Inc."]