Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05967299
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-07-27
Brief Title:
Study of Intravenous ZMA001 in Healthy Subjects
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase 1 Randomized Double-Blind Placebo-Controlled Single-Ascending Dose Study to Evaluate the Safety Tolerability and Pharmacokinetics of Intravenous ZMA001 in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-09-30
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
A number of diseases can cause a type of lung injury called pulmonary arterial hypertension PAH Most people who develop PAH do not survive more than a few years A new study drug ZMA001 may help ZMA001 is a monoclonal antibody This type of drug consists of proteins made in a facility that are very similar to proteins in a human body But before giving ZMA001 to people sick with PAH researchers want to find out how the drug affects healthy people
Objective
To test a drug ZMA001 in healthy volunteers
Eligibility
Healthy adults aged 18 to 60 years
Design
Participants will be screened They will have a physical exam with blood tests They will have a urine test for drug use They will have a test of their heart function
Participants will come to the clinic for 1 inpatient visit of up to 48 hours
ZMA001 is a liquid administered through a tube attached to a needle inserted into a vein in the arm Participants will receive this drug only once during their inpatient stay Some participants will receive the drug others will receive a placebo A placebo is a treatment that looks just like the real drug but contains no medicine Participants will not know which treatment they are getting
After a screening visit participants will have 1 inpatient visit and up to 6 outpatient visits over 16 weeks after receiving the treatment Blood draws and other tests will be repeated Each outpatient visit is approximately 2 hours long
This study is the first time ZMA001 will be administered to people
A number of diseases can cause a type of lung injury called pulmonary arterial hypertension PAH Most people who develop PAH do not survive more than a few years A new study drug ZMA001 may help ZMA001 is a monoclonal antibody This type of drug consists of proteins made in a facility that are very similar to proteins in a human body But before giving ZMA001 to people sick with PAH researchers want to find out how the drug affects healthy people
Objective
To test a drug ZMA001 in healthy volunteers
Eligibility
Healthy adults aged 18 to 60 years
Design
Participants will be screened They will have a physical exam with blood tests They will have a urine test for drug use They will have a test of their heart function
Participants will come to the clinic for 1 inpatient visit of up to 48 hours
ZMA001 is a liquid administered through a tube attached to a needle inserted into a vein in the arm Participants will receive this drug only once during their inpatient stay Some participants will receive the drug others will receive a placebo A placebo is a treatment that looks just like the real drug but contains no medicine Participants will not know which treatment they are getting
After a screening visit participants will have 1 inpatient visit and up to 6 outpatient visits over 16 weeks after receiving the treatment Blood draws and other tests will be repeated Each outpatient visit is approximately 2 hours long
This study is the first time ZMA001 will be administered to people
Detailed Description:
Study Description
ZMA001 is a fully human monoclonal antibody IgG1 that inhibits migration of activated monocytes and macrophages and reduces pulmonary vascular remodeling and pulmonary artery pressure in pre-clinical rodent models of pulmonary arterial hypertension PAH The current first-in-human randomized double-blind placebo-controlled single ascending-dose study will determine the safety tolerability and pharmacokinetics of intravenous ZMA001 in healthy subjects
Objectives
Primary Objective Safety and tolerability of ZMA001 in healthy subjects
Secondary Objectives Determine the pharmacokinetics of ZMA001 in healthy subjects following a single intravenous dose
Endpoints
Primary Endpoint The number of all-cause treatment-emergent adverse events grade 1 and above following CTCAE v50 criteria through day 113
Secondary Endpoints For each ZMA001 dose level 15 5 12 and 20 mgkg the following will be determined Timeframe Pre-infusion end of infusion 2 4 8 12 24 and 48h Days 8 29 57 85 and 113
1 Time to peak drug concentration Tmax
2 Peak drug concentration Cmax
3 Area under the drug concentration-time curve AUC
4 Elimination half-life
ZMA001 is a fully human monoclonal antibody IgG1 that inhibits migration of activated monocytes and macrophages and reduces pulmonary vascular remodeling and pulmonary artery pressure in pre-clinical rodent models of pulmonary arterial hypertension PAH The current first-in-human randomized double-blind placebo-controlled single ascending-dose study will determine the safety tolerability and pharmacokinetics of intravenous ZMA001 in healthy subjects
Objectives
Primary Objective Safety and tolerability of ZMA001 in healthy subjects
Secondary Objectives Determine the pharmacokinetics of ZMA001 in healthy subjects following a single intravenous dose
Endpoints
Primary Endpoint The number of all-cause treatment-emergent adverse events grade 1 and above following CTCAE v50 criteria through day 113
Secondary Endpoints For each ZMA001 dose level 15 5 12 and 20 mgkg the following will be determined Timeframe Pre-infusion end of infusion 2 4 8 12 24 and 48h Days 8 29 57 85 and 113
1 Time to peak drug concentration Tmax
2 Peak drug concentration Cmax
3 Area under the drug concentration-time curve AUC
4 Elimination half-life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001522-H | None | None | None |