AzTrials
AzTrials

Systemic Lupus Erythematosus (SLE)Phase 1NCT06144710

SG301-SC Injection Safety Study in Subjects With Systemic Lupus Erythematosus

A Phase 1 study testing SG301 SC Injection in people with Systemic Lupus Erythematosus (SLE), run by Hangzhou Sumgen Biotech Co., Ltd. at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single dose in healthy volunteers and multiple doses of SG301 SC injection in participants with systemic lupus erythematosus (SLE). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Systemic Lupus Erythematosus (SLE)
What is being tested?
SG301 SC Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
10 sitesChina
Study dates
10 Nov 2023to 7 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Part A (healthy volunteers)
  • Male healthy adults aged 18-50 years (inclusive);
  • Male participants weighed 50-100 kg (inclusive) with the body mass index of 19.0-27.0 kg/m2 (inclusive);
  • Participants whose partners are of childbearing potential must agree to use effective contraceptive methods throughout the study period and for 6 months following the last dose.
  • Part B (SLE participants)
  • Males or females aged 18-65 years (inclusive);
Show all 16Show fewer
  • BMI 18.5-30.0 kg/m2 (inclusive);
  • Have diagnosed as SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE classification criteria, with inadequate response or intolerance to or having relapsed despite the standard treatment;
  • SELENA-SLEDAI score >4 and ≤12;
  • Serologically ANA and/or anti-ds-DNA antibody tested positive;
  • Having received a standard treatment for at least 12 weeks prior to the first dose that has remained at a stable dose for at least 4 weeks prior to the first dose;
  • Laboratory values at screening meets the following criteria:
  • Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2ULN, total bilirubin <1.5×ULN;
  • Renal function: creatinine (Cr) and urea ≤1.5×ULN; eGFR >60 ml/min (calculated by the MDRD formula); urine total protein-creatinine ratio ≤3.0 g/g or 24h urine protein ≤3.5 g;
  • Bone marrow function: Hb≥100g/L, WBC≥3.0×109/L, PLT≥75×109/L;
  • Participants who are of childbearing potential or whose partners are of childbearing potential must agree to use effective contraceptive methods throughout the study period and for 6 months following the last dose.

Who cannot join

  • Part A (healthy volunteers)
  • Have a history of allergies or likely to be allergic to the investigational drug or any of their ingredients judged by the investigators;
  • Have previously received drugs of the same target (CD38);
  • Have participated in a clinical trial of any drug or medical device within 3 months or 5 half-lives prior to dosing, whichever is longer;
  • Have received any prescription drugs or Chinese herbal medicines within 4 weeks prior to dosing, or any non-prescription or dietary supplements within 2 weeks prior to dosing;
  • Have infections within 2 weeks prior to first dose (including but not limited to viral, bacterial, or fungal infections);
Show all 53Show fewer
  • Have experienced symptomatic herpes zoster within 3 months prior to dosing;
  • Presence of any of the following diseases assessed by the investigator as abnormal with clinical significance within 6 months prior to dosing;
  • Have a history of cardiovascular diseases within 6 months prior to dosing: chronic congestive heart failure (New York Heart Association [NYHA] Class III or IV), myocardial infarction, severe heart diseases (e.g., unstable angina, cardiogenic shock, arrhythmias requiring treatment, heart valve diseases, hypertrophic cardiomyopathy, and rheumatic heart disease, etc.), and familial long QT interval syndrome, etc.;
  • Presence of chronic nervous system symptoms such as dizziness and headache prior to dosing;
  • Blood cell count below the lower limit of normal (LLN), or clinically significant abnormalities in any other hematology tests within 1 week prior to dosing;
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.2×ULN, total bilirubin >1.2×ULN;
  • ECG abnormalities with clinical significance, e.g. QTcF >450 ms;
  • Any vital signs abnormal with clinical significance;
  • Fasting blood glucose above ULN;
  • Any abnormal from physical examination, laboratory tests, or chest CT with clinical significance;
  • Hepatitis B surface antigen (HBsAg) or core antibody (HBcAb) positive, hepatitis C virus (HCV) antibody positive, TPPA positive, or HIV antibody positive;
  • Mycobacterium tuberculosis infection;
  • Having received a live or attenuated live vaccine within 4 weeks prior to dosing or planning to do so during the trial;
  • Skin injection site abnormal, including but not limited to birthmarks, scars, black moles, tattoos, and open wounds;
  • Blood donation ≥400 ml or blood loss ≥400 ml within 4 weeks prior to dosing, or having received blood transfusion within 8 weeks prior to dosing;
  • A history of heavy drinking within 3 months prior to dosing;
  • A history of drug abuse within 5 years prior to dosing or use of narcotics within 3 months prior to the trial.
  • Part B (SLE participants)
  • Has a history of central nervous system disorders that require prohibited medicine treatment within 2 months prior to the first dose;
  • Presence of concomitant rheumatic diseases within 12 months prior to the first dose, including but not limited to rheumatoid arthritis, spondyloarthritis, dermatomyositis/polymyositis, Sjogren's syndrome, systemic sclerosis, mixed connective tissue disease, and overlap syndrome, etc.;
  • Presence of catastrophic antiphospholipid syndrome within 12 months prior to the first dose;
  • Has a history of non-SLE inflammatory skin or joint disease within 12 months prior to the first dose;
  • Presence of chronic active infection or acute infection within 4 weeks prior to first dose or superficial skin infection within 1 week prior to first dose;
  • A known or suspected history of immunosuppression;
  • Have undergone a major surgery within 12 weeks prior to the first dose or having an unhealed wound, ulcer or fracture, or planning to undergo a major surgery during the study;
  • Having participated in any clinical trial within 12 weeks prior to the first dose or have received other investigational products within 5 half-live, whichever is longer;
  • Have received any drugs targeting T or B lymphocytes (e.g., rituximab) within 6 months or cytokines or cytokines receptors (e.g., belimumab, telitacicept, etc.) treatment within 5 half-lives prior to the first dose;
  • Having received JAK inhibitors treatment within 12 weeks or 5 half-lives prior to the first dose, whichever is shorter;
  • Having received any of the following treatment within 12 weeks prior to the first dose:
  • Intravenous immunoglobulin (IVIG)
  • Plasma exchange
  • Intravenous cyclophosphamide;
  • Have diseases with major clinical significance within 6 months prior to first dose, including but not limited to circulatory system disorders, endocrine system disorders, nervous system disorders, blood system disorders, immune system disorders, and psychiatric disorders, etc.;
  • A history of cardiovascular diseases within 6 months prior to the first dose, including but not limited to chronic congestive heart failure (NYHA Class III or IV), myocardial infarction, severe heart diseases (e.g., unstable angina, cardiogenic shock, arrhythmias requiring treatment, heart valve diseases, hypertrophic cardiomyopathy, and rheumatic heart disease, etc.), QTcF >450 ms or familial long QT interval syndrome, poorly controlled hypertension;
  • Mycobacterium tuberculosis infection;
  • Presence of active hepatitis:
  • HBsAg positive and/or HBcAb positive and HBV DNA positive;
  • HCV antibody positive and HCV RNA positive;
  • HIV antibody positive;
  • Both TPPA and RPR positive;
  • Known allergy to monoclonal antibody drugs or to any excipient of the investigational drug;
  • Having received a live or attenuated live vaccine within 4 weeks prior to the first dose or planning to do so during the study;
  • Have a history of major organ transplantation or hematopoietic stem cell/ bone marrow transplantation;
  • Have a history of malignancy within 5 years prior to first dose;
  • Participants with depression or suicidal tendency;
  • Have a history of heavy drinking or drug abuse within 3 months prior to first dose;
  • Pregnant or breastfeeding women, or women who plan to become pregnant or may breastfeed during the study and for 6 months following the last dose; male participants whose partner plans to become pregnant during the study.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233000

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350004

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 314408

  • Shandong University Qilu Hospital

    Jinan, Shandong, 250063

  • Jining First People's Hospital

    Jining, Shandong, 272002

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337099

  • Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

  • First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Characteristics of SG301 SC Injection in Single-dose Healthy Subjects and Multiple-dose Systemic Lupus Erythematosus (SLE) Subjects

This is a randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single dose in healthy volunteers and multiple doses of SG301 SC injection in participants with systemic lupus erythematosus (SLE).

Read the detailed description

This is a phase I single ascending dose (SAD) study in healthy volunteers and multiple ascending dose (MAD) study in participants with mild or moderate SLE, which consists of Parts A and B. Part A adopts a single-center, open-label, dose escalation trial design, and Part B adopts a multi-center, randomized, double-blind, placebo-controlled trial design to evaluate the safety, tolerability, PK, and immunogenicity, preliminary efficacy of SG301 SC Injection in patients with mild to moderate SLE.

Being tested
SG301 SC Injection, SG301 SC Placebo
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SG301 SC InjectionDrug

    Subcutaneous injection every two weeks

  • SG301 SC PlaceboDrug

    Subcutaneous injection every two weeks

Study groups in NCT06144710
Study groupRoleWhat they receive
SG301 SCExperimentalPart A: Dose escalation of SG301 SC will be done in healthy volunteers at 1 mg/kg dose group and 2 mg/kg dose group. Part B: Dose escalation of SG301 SC will be done in Systemic lupus erythematosus subjects in 4 dose groups, namely 2 mg/kg, 4 mg/kg, 8 mg/kg, and 12 mg/kg dose groups. 8 subjects will be randomized to SG301 SC injection in an 8:2 ratio at each dose group.
Receives: Drug: SG301 SC Injection
PlaceboPlacebo comparatorPart B: Dose escalation of SG301 SC will be done in Systemic lupus erythematosus subjects in 4 dose groups, namely 2 mg/kg, 4 mg/kg, 8 mg/kg, and 12 mg/kg dose groups. 2 subjects will be randomized to SG301 SC injection in an 8:2 ratio at each dose group.
Receives: Drug: SG301 SC Injection; Drug: SG301 SC Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events(Part A and Part B)

    Number and percentage of AEs which are calculated by worst CTCAE grade by CTCAE 5.

    Measured: From baseline through the end of study. Part A: Average 2 months per subject, Part B: Average 5 months per subject.

Secondary outcomes (10)

  1. RP2D (PartB)

    RP2D will be determined based on the DLTs and safety data.

    Measured: From baseline through the end of study. Average 5 months per subject.

  2. Pharmacokinetics (PK): Cmax (Part A and Part B)

    Cmax to maximum drug concentration administration.

    Measured: From baseline through the end of study. Part A: Average 2 months per subject, Part B: Average 5 months per subject.

  3. Pharmacokinetics (PK): limination half-life (T1/2) (Part A and Part B)

    Limination half-life (T1/2) of the drug after administration.

    Measured: From baseline through the end of study. Part A: Average 2 months per subject, Part B: Average 5 months per subject.

  4. Immunogenicity (Part A and Part B)

    Anti-SG301 antibody (ADAdrug), neutralizing antibody (Nabdrug, to be detected only in case of the presence of ADAdrug), and anti-hyaluronidase antibody (ADArHu).

    Measured: From baseline through the end of study. Part A: Average 2 months per subject, Part B: Average 5 months per subject.

  5. PD endpoints: CD38 RO (Part B)

    Detect the CD38 RO

    Measured: From baseline through the end of study. Average 5 months per subject.

  6. Biomarkers evaluation (Part B)

    It includes anti-ds-DNA autoantibody and complement factors C3 and C4.

    Measured: From baseline through the end of study. Average 5 months per subject.

  7. Efficacy evaluation (Part B)

    Activity will be evaluated by SELENA SLEDAI.

    Measured: From baseline through the end of study. Average 5 months per subject.

  8. Evaluation of exploratory measures：immunoglobulins (Part B)

    Changes from baseline in immunoglobulins IgG, IgM and IgA with the investigational drug SG301 SC Injection and SG301 SC placebo.

    Measured: From baseline through the end of study. Average 5 months per subject.

  9. Evaluation of exploratory measures：BILAG-2004 /PGA (Part B)

    Changes from baseline in BILAG-2004 and PGA with the investigational drug SG301 SC Injection and SG301 SC placebo.

    Measured: From baseline through the end of study. Average 5 months per subject.

  10. Evaluation of exploratory measures：immune cell (Part B)

    Changes from baseline in the immune cell subsets including NK cells (activated and total), B cell subsets, plasmacytes, and plasmablasts, etc.

    Measured: From baseline through the end of study. Average 5 months per subject.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2023
  2. Study start10 Nov 2023
  3. Primary completion7 Jan 2026
  4. Study completion7 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This Study consists of Parts A and B. Part A ：Single dose of SG301 SC Injection in healthy volunteers. This part will consist of 1 mg/kg dose group (n=4) and 2 mg/kg dose group(n=4) , all 4 participants in each group will receive a single dose of SG301 SC Injection by abdominal subcutaneous injection. Part B：Multiple doses of SG301 SC Injection/SG301 SC placebo in SLE patients. The MAD will be performed at a ratio of 8:2 in 4 dose groups (n=10/group), namely 2 mg/kg, 4 mg/kg, 8 mg/kg, and 12 mg/kg dose groups. The SG301 SC Injection or SG301 SC placebo will be subcutaneously injected every 2 weeks \[Q2W\] in a 2-week cycle for a total of 6 doses in the MAD study.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06144710
Sponsor's protocol ID
CSG-301 SC-101
Status last verified
Aug 2026
First submitted
13 Nov 2023
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SG301 SC Injection in people with Systemic Lupus Erythematosus (SLE), run by Hangzhou Sumgen Biotech Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events(Part A and Part B) (time frame: From baseline through the end of study. Part A: Average 2 months per subject, Part B: Average 5 months per subject.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06144710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in