Safety and Tolerability Clinical Trial
Official title:
A Randomised, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570 Administered in Subjects With Overweight or Obesity
The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo within each cohort where the observational period is 18 weeks. All subjects will be dosed for 13 weeks with ascending weekly doses of ZP7570 at dose levels with corresponding volume of placebo.
ZP7570 is a dual GLP-1R/GLP-2R agonist in clinical development for weight management. The overall purpose of this trial is to evaluate the safety and tolerability when applying dose titration of ascending doses of ZP7570 and at steady state. The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo. All subjects will be dosed with ascending weekly doses of ZP7570 with corresponding volume of placebo. After informed consent has been obtained, eligibility of the subjects will be assessed during a screening Visit (V1). Additional tests to assess safety and PK and PD will take place during in-house visits and ambulatory visits. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05997641 -
Evaluating the Safety, Tolerability, and Pharmacokinetics of DF-003 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT06181760 -
A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT05907382 -
Safety, Tolerability of JMKX003002 in Phase 1 Study in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01952548 -
Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers
|
Phase 1 | |
| Recruiting |
NCT06453824 -
SAD Evaluation of Safety, Tolerability, PK, and PD of MDI-2517 in Healthy Participants
|
Phase 1 | |
| Completed |
NCT05431634 -
Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants
|
Phase 1 | |
| Recruiting |
NCT06331884 -
Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab)
|
Phase 1 | |
| Completed |
NCT03046589 -
DP13 SAD & MAD in Healthy Male Subjects
|
Phase 1 | |
| Recruiting |
NCT06079541 -
Phase 1 Clinical Study of JMKX003142 Tablets
|
Phase 1 | |
| Completed |
NCT05223660 -
A Phase I Pharmacokinetics Study for KT07 Capsule
|
Phase 1 | |
| Completed |
NCT01907867 -
Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin
|
Phase 1 | |
| Completed |
NCT03809052 -
A First in Human Study to Evaluate the Safety, Tolerability and PK of GB1211 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03853421 -
Placebo-controlled Study to Determine the Safety and Tolerability of Subcutaneous Doses of Sevuparin
|
Phase 1 | |
| Terminated |
NCT03307512 -
PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD
|
Phase 2 | |
| Completed |
NCT03685708 -
HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)
|
Phase 2 | |
| Completed |
NCT03702231 -
Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I)
|
Phase 2 | |
| Completed |
NCT03817346 -
Study of Ascending Single Oral Dose of GT-002 in Healthy Volunteers
|
Phase 1 | |
| Active, not recruiting |
NCT01226316 -
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules
|
Phase 1 | |
| Completed |
NCT05451667 -
Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of YJ001 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT02029482 -
Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-128800 in Healthy Subjects
|
Phase 1 |