A Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2025-03-31

Brief Summary

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This is a randomized, single blind, placebo controlled, single center phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of subcutaneously administered RBD7022 in participants with normal or elevated LDL-c cholesterol. The study will be performed in 2 phases: single ascending dose (SAD) phase and multiple ascending doses (MAD) phase in participants. The decision to escalate to subsequent dose levels will be made by the SRC based on the review of all available safety information in each cohort.

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Detailed Description

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Conditions

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Hyperlipemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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RBD7022 SAD experimental group

Subjects in SAD experimental groups will receive a single subcutaneous injection of RBD7022 on Day 0.

Group Type EXPERIMENTAL

RBD7022

Intervention Type DRUG

Subcutaneously Administered RBD7022 in Healthy Subjects.

RBD7022 MAD experimental group

Subjects in MAD experimental groups will receive one subcutaneous injection of RBD7022 on Day 0 and another subcutaneous injection of RBD7022 on Day 28.

Group Type EXPERIMENTAL

RBD7022

Intervention Type DRUG

Subcutaneously Administered RBD7022 in Healthy Subjects.

Placebo SAD group

Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 0.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneously Administered Placebo in Healthys Subject.

Placebo MAD group

Subjects in MAD placebo groups will receive one subcutaneous injection of placebo on Day 0 and another subcutaneous injection of placebo on Day 28 .

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneously Administered Placebo in Healthys Subject.

Interventions

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RBD7022

Subcutaneously Administered RBD7022 in Healthy Subjects.

Intervention Type DRUG

RBD7022

Subcutaneously Administered RBD7022 in Healthy Subjects.

Intervention Type DRUG

Placebo

Subcutaneously Administered Placebo in Healthys Subject.

Intervention Type DRUG

Placebo

Subcutaneously Administered Placebo in Healthys Subject.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects, aged 18 to 65 years, inclusive
* Body mass index between 17 and 28 kg/m2 , inclusive
* LDL-C normal or elevated at screening and baseline.
* Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent.
* The clinical laboratory examination of the subjects was within the normal range, or abnormal but had no clinical significance as judged by the investigators, and did not affect the study results;
* Vital signs, physical examination, ECG, ultrasound showed normal or abnormal but no clinically significant as determined by the investigator.

Exclusion Criteria

* With a clear history of primary diseases of major organs, the subject is not suitable to participate in this study considered by the investigator;
* Diagnosis of diabetes mellitus;
* Pregnant or breastfeeding women;
* Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes