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

NCT06144710 | Active Not Recruiting Phase 1

• 1 other identifier: CSG-301 SC-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (10)

• RP2D (PartB)

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

• Pharmacokinetics (PK): Cmax (Part A and Part B)

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

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

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

• Immunogenicity (Part A and Part B)

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

• PD endpoints: CD38 RO (Part B)

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

Study Arms (2)

SG301 SC

EXPERIMENTAL

Part 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.

Drug: SG301 SC Injection

Placebo

PLACEBO COMPARATOR

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. 2 subjects will be randomized to SG301 SC injection in an 8:2 ratio at each dose group.

Drug: SG301 SC Injection; Drug: SG301 SC Placebo

Interventions

SG301 SC Injection DRUG

Subcutaneous injection every two weeks

Placebo; SG301 SC

SG301 SC Placebo DRUG

Subcutaneous injection every two weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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;

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Hangzhou Sumgen Biotech Co., Ltd.: lead

Study Sites (10)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233000, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

Location

First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

Location

Pingxiang People's Hospital

Pingxiang, Jiangxi, 337099, China

Location

Shandong University Qilu Hospital

Jinan, Shandong, 250063, China

Location

Jining First People's Hospital

Jining, Shandong, 272002, China

Location

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 314408, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Part A：Open-label Part B：Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 22, 2023
• Study Start: November 10, 2023
• Primary Completion: January 7, 2026
• Study Completion (Estimated): October 24, 2026
• Last Updated: March 9, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)