Study of Intravenous ZMA001 in Healthy Subjects
- Conditions
- Pulmonary Arterial Hypertension PAH
- Interventions
- Other: PlaceboDrug: ZMA001 (BC-NKA-20008)
- Registration Number
- NCT05967299
- 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.
- 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 v5.0 criteria) through day 113
Secondary Endpoints: For each ZMA001 dose level (1.5, 5, 12 and 20 mg/kg), 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
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo for ZMA001 is supplied in a single-use 10 mL glass vial. Each vial contains 30 mg/mL of sucrose.Placebo drug is manufactured using the same ingredients as active drug (20 mM histidine-HCl buffer \[pH 5.6\], 30 mg/mL sucrose, 0.070 w/v% polysorbate 80) excluding ZMA001 antibody and is packed in the same vial. ZMA001 (BC-NKA-20008) ZMA001 (BC-NKA-20008) 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).
- Primary Outcome Measures
Name Time Method Safety and tolerability of ZMA001 in healthy subjects day 113 The number of all-cause, treatment-emergent adverse events, grade 1 and above (following CTCAE v5.0 criteria) through day 113
- Secondary Outcome Measures
Name Time Method Determine the pharmacokinetics of ZMA001 in healthy subjects following a single, intravenous dose. Pre-infusion, end of infusion, 2, 4, 8, 12, 24, and 48h; Days 8, 29, 57, 85 and 113 For each ZMA001 dose level (1.5, 5, 12, and 20mg/kg), the following will be determined1. Time to peak drug concentration (Tmax)2. Peak drug concentration (Cmax)3. Area under the drug concentration-time curve(AUC)
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States