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

NCT07042594 | Active Not Recruiting Phase 1

• 1 other identifier: RBFI2101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0

  Up to Day 85

Secondary Outcomes (9)

• Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0

  After day 85

• To characterize the pharmacokinetics (PK) as maximum plasma concentration (Cmax) of RBD1119 in healthy participants

  Up to 48 hours post-dose

• To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in intrinsic coagulation pathway related antigen levels in healthy participants.

  Up to Day 169.

• To characterize the pharmacokinetics (PK) as Time to reach Cmax (Tmax) of RBD1119 in healthy participants

  Up to 48 hours post-dose

• To characterize the pharmacokinetics (PK) as area under the plasma concentration-time curve from the time zero to the last measurable concentration (AUC0-t) of RBD1119 in healthy participants

  Up to 48 hours post-dose

Study Arms (2)

RBD1119 SAD experimental group

EXPERIMENTAL

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

Drug: RBD1119

Placebo SAD group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

RBD1119 DRUG

Subcutaneously Administered RBD1119 in Healthy Subjects.

RBD1119 SAD experimental group

Placebo DRUG

Subcutaneously Administered Placebo in Healthy Subject.

Placebo SAD group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Ribo Life Science Co. Ltd.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 29, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

AU (1)