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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

∙ 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;

⁃ 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.

Locations
Other Locations
China
The First Affiliated Hospital of Bengbu Medical College
RECRUITING
Bengbu
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Shandong University Qilu Hospital
RECRUITING
Jinan
Jining First People's Hospital
RECRUITING
Jining
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
Pingxiang People's Hospital
RECRUITING
Pingxiang
Huashan Hospital affiliated to Fudan University
RECRUITING
Shanghai
Shenzhen People's Hospital
RECRUITING
Shenzhen
First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Contact Information
Primary
Dafei Ding
dingdafei@sumgenbio.com
+86 010-56315401
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2026-10-24
Participants
Target number of participants: 48
Treatments
Experimental: SG301 SC
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.
Placebo_comparator: Placebo
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.
Related Therapeutic Areas
Sponsors
Leads: Hangzhou Sumgen Biotech Co., Ltd.

This content was sourced from clinicaltrials.gov

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