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

NCT ID: NCT07042594

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-26
• Study Completion Date: 2026-09-30

Brief Summary

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RBD1119 SAD experimental group

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

Group Type: EXPERIMENTAL

RBD1119

Intervention Type: DRUG

Subcutaneously Administered RBD1119 in Healthy Subjects.

Placebo SAD group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneously Administered Placebo in Healthy Subject.

Interventions

RBD1119

Subcutaneously Administered RBD1119 in Healthy Subjects.

Intervention Type: DRUG

Placebo

Subcutaneously Administered Placebo in Healthy Subject.

Intervention Type: DRUG

Eligibility Criteria

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).

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suzhou Ribo Life Science Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Gabrielsen, MD

Role: STUDY_CHAIR

Suzhou Ribo Life Science Co. Ltd.

Locations

CMAX Clinical Research

Adelaide, , Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Sepehr Shakib, Prof

Role: CONTACT

Sepehr.Shakib@cmax.com.au

+61(0)8 7088 7900

Facility Contacts

Sarada Radha

Role: primary

Sarada.Radha@cmax.com.au

+61432411795

Other Identifiers

RBFI2101

Identifier Type: -

Identifier Source: org_study_id