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Active, Not Recruiting

NCT Number: NCT07042594

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research

Adelaide, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RBD1119

Drug

Subcutaneously Administered RBD1119 in Healthy Subjects.

Placebo

Drug

Subcutaneously Administered Placebo in Healthy Subject.

Primary outcomes

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

    Time frame: Up to Day 85

Secondary outcomes

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

    Time frame: After day 85

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

    Time frame: Up to 48 hours post-dose

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

    Time frame: Up to Day 169.

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

    Time frame: Up to 48 hours post-dose

  5. 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

    Time frame: Up to 48 hours post-dose

  6. To characterize the pharmacokinetics (PK) as area under the plasma concentration-time from time zero to infinity (AUC0-inf) of RBD1119 in healthy participants

    Time frame: Up to 48 hours post-dose

  7. To characterize the pharmacokinetics (PK) as apparent terminal elimination half-life (t1/2) of RBD1119 in healthy participants

    Time frame: Up to 48 hours post-dose

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

    Time frame: Up to Day 169.

  9. To evaluate the pharmacodynamics (PD) effect of RBD1119 as percentage change from baseline in APTT in healthy participants.

    Time frame: Up to Day 169.

Sponsors and collaborators

Lead sponsor

Suzhou Ribo Life Science Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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