Active, not recruitingNCT07042594ClinicalTrials.gov record

Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD1119 in Healthy Participants

Healthy Volunteers

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Phase 1
Age range: 18 years - 65 years
Sex eligible: All sexes
Healthy volunteers: Accepted
Participants: 32 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This is a Randomized, Single-blind, Placebo-Controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Subcutaneously Administered RBD1119 in Healthy Participants.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Single masked

RBD1119 SAD experimental group

Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD1119 on Day 1.

Drug: RBD1119

Placebo SAD group

Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1

Drug: Placebo

RBD1119 DRUG

Subcutaneously Administered RBD1119 in Healthy Subjects.

Placebo DRUG

Subcutaneously Administered Placebo in Healthy Subject.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.