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

Suzhou Ribo Life Science

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: RBD1119

Study type: Interventional

Funder types: Industry

Identifiers

NCT07042594

RBFI2101

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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32 participants in 2 patient groups, including a placebo group

RBD1119 SAD experimental group

Experimental group

Description:

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

Treatment:

Drug: RBD1119

Placebo SAD group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo