New drug RBD1119 put to the test in healthy volunteers
NCT ID NCT07042594
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This early-stage study tests a single injection of a new drug, RBD1119, in 32 healthy adults aged 18 to 65. The main goal is to check for side effects and see how the drug moves through the body. Participants are randomly assigned to receive either the drug or a placebo, and no one knows which they got. This study does not aim to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2025
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main Inclusion Criteria: * Male or female healthy participants (non-childbearing potential only), aged 18 to 65 years at screening, inclusive. * Body mass index (BMI) between 18 and 32 kg/m2, inclusive * APTT, Prothrombin time (PT), INR, thrombin time (TT) within normal reference range (as per the local laboratory). * Haematology results within normal range, unless deemed not clinically significant by the Principal Investigator or delegate. Platelet count however must be within normal range per the local laboratory reference ranges. * Healthy as determined by no clinically significant findings by the Principal Investigator or delegate in medical history, vital signs, physical examination, clinical laboratory assessments, and 12-lead electrocardiogram (ECG). Main Exclusion Criteria: * Any uncontrolled or serious disease that may interfere with participation in the clinical trial and/or put the participant at significant risk (according to Principal Investigator or delegate's judgment) if he/she participates in the clinical trial. * History or presence of cardiovascular disease (including peripheral artery and cerebrovascular disease). * Systolic blood pressure (SBP) is less than 90 or greater than 140 mmHg and/or diastolic blood pressure (DBP) is less than 50 or greater than 95 mmHg after 10 minutes of supine rest, unless determined by the Principal Investigator or delegate to be not clinically significant. * Diagnosis of diabetes mellitus, history of gestational diabetes that has not been fully resolved is not permitted. * History or presence of: * Bleeding disorder(s) and/or at risk of bleeding, including relevant familial history, such as Hemophilia A, Hemophilia B, Wiskott-Aldrich syndrome, von Willebrand disease (vWD); * Clinically significant anemia, in the opinion of the Principal Investigator or delegate; * Thromboembolic diseases; * Bleeding in the gastrointestinal tract or central nervous system; * Anticipated need for oral surgery or tooth extractions during the trial period; * Bleeding in the genitourinary tract; * Gum disease or active gum bleeding; * Planned surgery during the trial period.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CMAX Clinical Research
Adelaide, Australia
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