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New treatment option for Pulmonary Arterial Hypertension PAH
Official title Study of Intravenous ZMA001 in Healthy Subjects
ClinicalTrials.gov ID: NCT05967299
What this study is testing
What is ZMA001 (BC-NKA-20008)?
ZMA001 (BC-NKA-20008) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pulmonary arterial hypertension pah.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 16 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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...
You likely can't join if
- An individual who meets any of the following criteria prior to informed consent will be excluded from participation in this study:
- Pregnancy or lactation. Females of childbearing potential must have a negative serum Beta-human chorionic gonadotropin test no more than 48 hours...
- 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
- Recent infection or febrile illness within the past 14 days
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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.
- Males sexually active with a female partner must agree to use a condom with spermicide for 120 days after study drug infusion or be surgically sterile for at least 90 days before screening. Males must also agree to not...
- Agreement to adhere to Lifestyle Considerations throughout study duration
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Enrollment of healthy male people will be limited to no more than 14 out of the total study cohort of 32 in order to ensure an adequate representation of female people. Accepted methods of contraception for females of...
- Use of an implanted or intrauterine hormonal device for at least 30 consecutive days before study drug infusion
- Use of oral, patch or injectable contraceptives or a vaginal hormonal device for at least 30 consecutive days before study drug infusion
- Use of a non-hormonal intrauterine device for at least 30 consecutive days before study drug infusion
- Two barrier methods such as a diaphragm with spermicide or a condom with spermicide
- An individual who meets any of the following criteria prior to informed consent will be excluded from participation in this study:
- 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
- Recent infection or febrile illness within the past 14 days
- Treatment with another investigational drug within the past 30 days or 5 half-lives, whichever is longer
- Any vaccination within the past 4 weeks or receipt of a live-attenuated vaccine within the past 6 months
- Use of tobacco products within the past 3 months
- Illicit drug use (e.g. cocaine, opioids, methamphetamine, PCP) within the past 6 months or positive urine drug screen at Screening Visit
- Marijuana (cannabis) use within the past 30 days or positive urine drug screen at Screening Visit
- History of alcohol abuse within the past 2 years
- Current clinically significant medical illness that is uncontrolled despite appropriate medical treatment including (but not limited to) hematologic, oncologic, renal, endocrine, pulmonary, gastrointestinal...
- Body mass index less than 17 or greater than 32 kg/m\^2
- Clinically significant abnormal results on clinical blood testing completed at the Screening Visit
- Electrocardiographic evidence of clinically relevant heart disease
- Diabetes mellitus requiring medical treatment
- Received another monoclonal antibody in the past 30 days
- Use of herbal supplements, or similar products within the past 2 weeks
- Blood donation equal to or above 500 mL within 2 months prior to dosing.
- Any other finding that, in the judgment of the Investigator, would increase the risk of having an adverse outcome from participating in the study. Justification to exclude minors: Given that the vast majority of...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.