Study of Intravenous ZMA001 in Healthy Subjects
ConditionPulmonary Arterial Hypertension PAH
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
About this trial
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 in Cohort 1 only. 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 in Cohort 1. Cohorts 2-4 will receive a single dose of the study drug, administered through a tube attached to a needle inserted into a vein in the arm.
After a screening visit, participants will have 1 inpatient visit and up to 8 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Stated willingness to comply with all study procedures and availability for the duration of the study
Male* or female, aged 18 to 60 years, inclusive
In good general health as evidenced by medical history
Females of childbearing potential agree to use an accepted method of contraception (see below) throughout study participation and for 120 days after study drug infusion.
Disqualifiers
Pregnancy or lactation. Females of childbearing potential must have a negative serum Beta-human chorionic gonadotropin test no more than 48 hours from study drug infusion.
A history of human immunodeficiency virus (HIV) infection.
History of severe drug or excipient allergy or hypersensitivity
Known allergy to any of the components of the investigational drug or placebo
Trial design
Design model
Sequential
Treatments tested in this trial
Placebo Cohort 1 (1.5 mg/kg/dose) only
Other intervention30mg/ml Sucrose
ZMA001 (BC-NKA-20008)
DrugZMA001 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).
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Placebo Cohort 1 (1.5 mg/kg/dose) onlyPlacebo comparator 1 intervention
Group B: ZMA001 (BC-NKA-20008)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability of ZMA001 in healthy subjects
The number of all-cause, treatment-emergent adverse events, grade 1 and above (following CTCAE v5.0 criteria) through day 113
Time frame
day 113Secondary outcomes
1
Determine the pharmacokinetics of ZMA001 in healthy subjects following a single, intravenous dose.
For each ZMA001 dose level (1.5, 0.25, 0.50, and 1.0 mg/kg), the following will be determined.3. Area under the drug concentration-time curve(AUC)
Time frame
Pre-infusion, end of infusion, 2, 4, 8, 12, 24, and 48h; Days 8, 15, 22, 29, 57, 85 and 1132
Determine the pharmacokinetics of ZMA001 in healthy subjects following a single, intravenous dose.
For each ZMA001 dose level (1.5, 0.25, 0.50, and 1.0 mg/kg), the following will be determined.2. Peak drug concentration (Cmax)
Time frame
Pre-infusion, end of infusion, 2, 4, 8, 12, 24, and 48h; Days 8, 15, 22, 29, 57, 85 and 1133
Determine the pharmacokinetics of ZMA001 in healthy subjects following a single, intravenous dose.
For each ZMA001 dose level (1.5, 0.25, 0.50, and 1.0 mg/kg), the following will be determined.1. Time to peak drug concentration (Tmax)
Time frame
Pre-infusion, end of infusion, 2, 4, 8, 12, 24, and 48h; Days 8, 15, 22, 29, 57, 85 and 113Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Heart, Lung, and Blood Institute (NHLBI)
Lead sponsor
Zymedi, Co., Ltd.
Collaborator
Source ClinicalTrials.gov