SA030 Injection in Healthy Participants

November 9, 2026 updated by: Suzhou Siran Biotechnology Co.,Ltd.

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of SA030 Injection in Healthy Participants

This is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single ascending doses of SA030 injection in healthy participants. The planned dose levels include 100 mg, 200 mg, and 400 mg, with 8 eligible participants enrolled in each dose group.

All participants receive a single administration of the study drug on Day 1 (D1). In each dose group, the first 2 participants are enrolled as sentinel participants and randomized at a 1:1 ratio to receive either SA030 injection or placebo. After a 5-day safety observation period and favorable safety assessment by the investigator, the remaining 6 participants in the group will be enrolled and randomized at a 5:1 ratio to receive SA030 injection or placebo.

For dose escalation, at least 6 out of 8 participants in each dose group must complete the 14-day safety observation period (up to Day 15 [D15]). Subsequent dose escalation to the next higher dose level can only be initiated after safety review and approval by the Safety Review Committee (SRC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • The First Bethune Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants aged 18 to 55 years, with a BMI of 25-40 kg/m².
  • Healthy participants as determined by medical history, physical examination, vital signs, ECG and laboratory assessments.
  • Willing to use effective contraception and have no pregnancy plans from screening to 6 months after study drug administration and/or throughout the study, with no intent to donate sperm or ova.

Exclusion Criteria:

  • Medical history：

    • Nervous, cardiovascular, hematologic/lymphatic, immune, gastrointestinal, renal, respiratory, endocrine disorders, history of malignancy, or psychiatric/psychological conditions
    • Has hypertension at screening (blood pressure ≥150/95 mmHg), diabetes mellitus (FPG ≥7.0 mmol/L and/or HbA1c ≥7.0%), hyperlipidemia (LDL-C ≥4.9 mmol/L or TG ≥500 mg/dL (5.65 mmol/L)), or gout.
    • Has a history of bleeding disorders, recent active bleeding, or clinically significant bleeding risk; or has coagulation abnormalities deemed clinically significant by the Investigator at screening.
    • Tests positive for HBV, HCV, HIV, or syphilis (positive Treponema pallidum, excluding those with negative RPR).
    • Has undergone major surgery within 6 months prior to screening, or plans to undergo surgery during the study period.
    • Has severe infection or trauma within 4 weeks prior to screening.
    • Has clinically significant hepatic space-occupying lesions, gallbladder lesions, pancreatic or renal abnormalities identified on abdominal ultrasound at screening.
    • Has severe allergic diathesis.
    • Has prior severe intolerance to subcutaneous injection.
    • Has skin abnormalities at injection sites.
    • Has risk factors for TdP, requires concurrent use of QT/QTc-prolonging / TdP-inducing drugs, or has high-risk bundle branch block.

  • Has clinically significant laboratory abnormalities at screening as judged by the Investigator.

  • concomitant medications：

    • Has received live attenuated vaccine within 1 month prior to screening, or plans to receive live attenuated vaccine during the study period.
    • Has used any prescription drugs, herbal medicines, or over-the-counter medications within 14 days prior to administration of the investigational product.
    • Has used any over-the-counter medications, herbal medicines or dietary supplements that may significantly affect body weight or metabolism within 1 month prior to screening.
    • Has participated in another drug clinical trial within 3 months prior to treatment in this study or within 5 half-lives of the other investigational product ; or has prior use of siRNA or antisense oligonucleotide drugs within 6 months prior to administration of the study drug.

  • Other

    • Has non-physiological blood loss ≥ 400 mL within 1 month prior to screening (including trauma, blood sampling, blood donation), or plans to donate blood during the study or within 30 days after study drug administration.
    • Has weekly alcohol intake >14 units within 3 months prior to screening ; or has a positive alcohol breath test on the day before dosing ; or is unable to abstain from alcohol during the in-hospital study period.
    • Has current or history of illicit drug use/substance abuse, or tests positive on urine drug screen on the day prior to dosing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SA030 Injection, 100 mg

Single subcutaneous injection of SA030 at 100 mg dose, one-time administration.
Drug: Experimental: 100mg

Single subcutaneous injection of SA030 injection at a dose of 100 mg, one-time administration on Day 1.
Experimental: SA030 Injection, 200mg

Single subcutaneous injection or SA030 at 200 mg dose, one-time administration.
Drug: Experimental: 200mg

Single subcutaneous injection of SA030 injection at a dose of 200 mg, one-time administration on Day 1.
Experimental: SA030 Injection, 400mg

Single subcutaneous injection or SA030 at 400 mg dose, one-time administration.
Drug: Experimental: 400mg

Single subcutaneous injection of SA030 injection at a dose of 400 mg, one-time administration on Day 1.
Placebo Comparator: placebo

Single subcutaneous injection of placebo, one-time administration.
Drug: Placebo

Single subcutaneous injection of placebo, one-time administration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Approximatly 9 months
Approximatly 9 months
Number of participants with clinically significant laboratory abnormalities
Time Frame: Approximatly 9 months
Approximatly 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Peak plasma concentration (Cmax)
Time Frame: Pre-dose, multiple timepoints post-dose up to D15
Pre-dose, multiple timepoints post-dose up to D15
Time to peak plasma concentration (Tmax)
Time Frame: Pre-dose, multiple timepoints post-dose up to D15
Pre-dose, multiple timepoints post-dose up to D15
Plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t)
Time Frame: Pre-dose, multiple timepoints post-dose up to D15
Pre-dose, multiple timepoints post-dose up to D15
Elimination half-life (t1/2)
Time Frame: Pre-dose, multiple timepoints post-dose up to D15
Pre-dose, multiple timepoints post-dose up to D15
Changes in BMI
Time Frame: baseline, up to 9 months
baseline, up to 9 months
Changes in body fat content
Time Frame: baseline, up to 9 months
baseline, up to 9 months
Changes in hepatic fat content
Time Frame: baseline, up to 9 months
baseline, up to 9 months
Changes in ALK7 expression
Time Frame: baseline, up to 9 months
baseline, up to 9 months
Number of participants with anti-SA030 antibodies (immunogenicity)
Time Frame: baseline, up to 9 months
baseline, up to 9 months
Change in QTcF relative to baseline and relative to placebo compared to baseline
Time Frame: Pre-dose, multiple timepoints post-dose up to Day 5
Pre-dose, multiple timepoints post-dose up to Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suzhou Siran Biotechnology Co.,Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAOB101-CN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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