SA030 Injection in Healthy Participants

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: Not yet recruiting
• Conditions: Weight Management
• Intervention / Treatment: Drug: Experimental: 100mg; Drug: Experimental: 200mg; Drug: Experimental: 400mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hong Zhang; Phone Number: +86 15298351869; Email: zhanghong@siranbio.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • The First Bethune Hospital of Jilin University
      • Contact: Hong Zhang; Phone Number: +86 18186870853; Email: jhongzhang@foxmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Number of participants with adverse events (AEs) and serious adverse events (SAEs)	Approximatly 9 months
Number of participants with clinically significant laboratory abnormalities	Approximatly 9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Peak plasma concentration (Cmax)	Pre-dose, multiple timepoints post-dose up to D15
Time to peak plasma concentration (Tmax)	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)	Pre-dose, multiple timepoints post-dose up to D15
Elimination half-life (t1/2)	Pre-dose, multiple timepoints post-dose up to D15
Changes in BMI	baseline, up to 9 months
Changes in body fat content	baseline, up to 9 months
Changes in hepatic fat content	baseline, up to 9 months
Changes in ALK7 expression	baseline, up to 9 months
Number of participants with anti-SA030 antibodies (immunogenicity)	baseline, up to 9 months
Change in QTcF relative to baseline and relative to placebo compared to baseline	Pre-dose, multiple timepoints post-dose up to Day 5

Collaborators and Investigators

• Sponsor: Suzhou Siran Biotechnology Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 16, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: October 8, 2026
• First Submitted That Met QC Criteria: November 9, 2026
• First Posted (Actual): November 13, 2026

Study Record Updates

• Last Update Posted (Actual): November 13, 2026
• Last Update Submitted That Met QC Criteria: November 9, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Phase 1; single ascending dose; healthy participants; SA030 injection
• Other Study ID 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