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Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers

Primary Purpose

Autoimmune Disease

Status
Not yet recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
SCT650C
Sponsored by
Sinocelltech Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Disease focused on measuring IL-17A monoclonal antibody

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male or female participants aged 18 to 65 years, inclusive, at the time of screening; 1a) Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1 and must not be breastfeeding, lactating or planning pregnancy during the study period. WOCBP must maintain an acceptable form of contraception (see Appendix 2) from Screening until 180 days from study drug dosing; • WOCBP are defined as any female who has experienced menarche, who has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy or tubal ligation) and is not postmenopausal; Menopause is defined as 12 months of amenorrhea in the absence of other biological causes. This will be confirmed by documented serum follicle stimulating hormone (FSH) levels > 40 milli-International unit/mL to confirm menopause; Contraception requirements do not apply to WOCBP in same-sex relationships. 1b) A male subject with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception (see Appendix 2) during the treatment period and for at least 180 days post dose. Contraception requirements do not apply to: - male participants in same-sex relationships, or - male participant whose female partners are not of childbearing potential, whether surgically sterile or postmenopausal (FSH level required). Male participants should avoid donating sperm for at least 180 days post-dose. Healthy male and female participants, with no significant medical history, and in good health as determined by detailed medical history, full physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests; Body mass index (BMI) 18-32 kg/m2 and male weight ≥50 kg, and female weight ≥45 kg during the screening; Participants who signed the informed consent, and are considered reliable and capable of adhering to the protocol (e.g., able to understand), visit schedule, and medication intake according to the judgment of the investigator. Exclusion Criteria: 1) Recent use of any biological agents within 3 months before screening. Biological agents encompass a range of medicines derived from biological sources, including but not limited to some vaccines, growth factors, immune modulators, monoclonal antibodies, and products derived from human blood and plasma. 2) Recent use of prescription medicines, over-the-counter medicines, vitamins or supplements within 7 days, or 5 half-lives (whichever is longer) prior to dosing at the investigators' discretion. 3) Vaccination with live vaccine within 4 weeks prior to study drug administration, vaccination with an inactivated vaccination within 2 weeks prior to study drug administration, or intention to receive a live vaccine during the study period. 4) Participants who have received an investigational drug in the previous 90 days or 5 half-lives, whichever is longer, prior to Day 1 dosing. 5) Participants have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the participant if participating in this study. 6) Acute infection within 30 days prior to study drug administration. 7) Participants with active tuberculosis or latent tuberculosis, or those with history of previous tuberculosis infection. 8) Histories of lymphoproliferative disease within 5 years; current history of malignancy or a history of malignancy within 5 years (except for squamous cell carcinoma of the skin, basal cell carcinoma, and cervical cancer in situ after thorough treatment without any signs of recurrence). 9) Participants with a personal history of, or symptoms consistent with, inflammatory bowel disease (IBD). 10) Associated with an active infection, or with an infection history: a. Systemic anti-infective treatment 4 weeks before administration of study drug; b. Serious infection with hospitalization or intravenous anti-infective treatment within 8 weeks before administration of study drug; c. Recurrent, chronic or other active infections, which are assessed by the investigator to increase the risk of the participant. 11) Positive results of any of the following: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis B virus (HBV) deoxyribonucleic acid (DNA), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, interferon-gamma release assay (IGRA) or treponema pallidum particle agglutination (TPPA). 12) Female participants who are breastfeeding, pregnant, or male participants who plan to father children during the study. 13) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >1.5 times the upper limit of normal (ULN) at screening or Day -1; White cell count < 3.0; Neutrophil count < 2.0; Platelet count < 150. These tests can be repeated once at the investigator's discretion 14) Presence of any medical condition, mental health condition or suicidal ideation/behavior, which would make the participant unsuitable for inclusion in the study. 15) Participants who underwent major surgery within 8 weeks prior to baseline, or are planning to undergo major surgery during the study.

Sites / Locations

  • Linear Clinical Research - Joonadalup
  • Linear Clinical Research - B Block
  • Linear Clinical Research - Harry Perkins

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

80 mg SCT650C or normal saline

160 mg SCT650C or normal saline

40 mg SCT650C or normal saline

20 mg SCT650C or normal saline

Arm Description

Eight qualified participants will be randomized at a ratio of 6:2 to receive 80 mg SCT650C or normal saline on Day 1

Eight qualified participants will be randomized at a ratio of 6:2 to receive 160 mg SCT650C or normal saline on Day 1

Eight qualified participants will be randomized at a ratio of 6:2 to receive 40 mg SCT650C or normal saline on Day 1

Eight qualified participants will be randomized at a ratio of 6:2 to receive 20mg SCT650C or normal saline on Day 1

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Secondary Outcome Measures

Percentage of participants with at least one treatment-emergent serious adverse event (SAE)
An SAE is any AE that fulfills one or more of the following: Results in death; Is life-threatening; Requires hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability or incapacity; Results in a congenital abnormality or birth defect; Important medical event
Peak Plasma Concentration (Cmax) of SCT650C
Pharmacokinetics: Cmax is the maximum observed concentration of SCT650C into serum.
Area under the plasma concentration versus time curve (AUC) of SCT650C
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.
The level of anti-drug antibodies (ADA) to SCT650C
Immunogenicity as measured by anti-drug antibodies (ADA) to SCT650C over time

Full Information

First Posted
May 29, 2023
Last Updated
June 7, 2023
Sponsor
Sinocelltech Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05894707
Brief Title
Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers
Official Title
A Randomized, Double-blinded, Dose-escalation Phase Ia Study to Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinocelltech Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goal of clinical trial is to evaluate the safety and tolerability of SCT650C in healthy participants.
Detailed Description
Interleukin-17A (IL-17A) is a new potential therapeutic target which plays important role in pathogenesis of several autoimmune disorders including psoriasis, rheumatoid arthritis, possibly - systemic lupus erythematosus (SLE) and multiple sclerosis (MS). SCT650C is a novel humanized monoclonal antibody against human IL-17A developed by Sinocelltech which is now on the first step of clinical evaluation. SCT650C-612-1-01 study is the first-in-human clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics and immunogenicity of SCT650C in healthy volunteers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Disease
Keywords
IL-17A monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
80 mg SCT650C or normal saline
Arm Type
Experimental
Arm Description
Eight qualified participants will be randomized at a ratio of 6:2 to receive 80 mg SCT650C or normal saline on Day 1
Arm Title
160 mg SCT650C or normal saline
Arm Type
Experimental
Arm Description
Eight qualified participants will be randomized at a ratio of 6:2 to receive 160 mg SCT650C or normal saline on Day 1
Arm Title
40 mg SCT650C or normal saline
Arm Type
Experimental
Arm Description
Eight qualified participants will be randomized at a ratio of 6:2 to receive 40 mg SCT650C or normal saline on Day 1
Arm Title
20 mg SCT650C or normal saline
Arm Type
Experimental
Arm Description
Eight qualified participants will be randomized at a ratio of 6:2 to receive 20mg SCT650C or normal saline on Day 1
Intervention Type
Drug
Intervention Name(s)
SCT650C
Other Intervention Name(s)
Recombinant anti-IL-17A antibody
Intervention Description
Recombinant anti-IL-17A antibody
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame
Baseline (Day 1, IP administration) up to 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of participants with at least one treatment-emergent serious adverse event (SAE)
Description
An SAE is any AE that fulfills one or more of the following: Results in death; Is life-threatening; Requires hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability or incapacity; Results in a congenital abnormality or birth defect; Important medical event
Time Frame
Baseline (Day 1, IP administration) up to 24 weeks
Title
Peak Plasma Concentration (Cmax) of SCT650C
Description
Pharmacokinetics: Cmax is the maximum observed concentration of SCT650C into serum.
Time Frame
Baseline (Day -1 predose) up to 24 weeks
Title
Area under the plasma concentration versus time curve (AUC) of SCT650C
Description
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.
Time Frame
Baseline (Day -1 predose) up to 24 weeks
Title
The level of anti-drug antibodies (ADA) to SCT650C
Description
Immunogenicity as measured by anti-drug antibodies (ADA) to SCT650C over time
Time Frame
Baseline (Day -1 predose) up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female participants aged 18 to 65 years, inclusive, at the time of screening; 1a) Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1 and must not be breastfeeding, lactating or planning pregnancy during the study period. WOCBP must maintain an acceptable form of contraception (see Appendix 2) from Screening until 180 days from study drug dosing; • WOCBP are defined as any female who has experienced menarche, who has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy or tubal ligation) and is not postmenopausal; Menopause is defined as 12 months of amenorrhea in the absence of other biological causes. This will be confirmed by documented serum follicle stimulating hormone (FSH) levels > 40 milli-International unit/mL to confirm menopause; Contraception requirements do not apply to WOCBP in same-sex relationships. 1b) A male subject with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception (see Appendix 2) during the treatment period and for at least 180 days post dose. Contraception requirements do not apply to: - male participants in same-sex relationships, or - male participant whose female partners are not of childbearing potential, whether surgically sterile or postmenopausal (FSH level required). Male participants should avoid donating sperm for at least 180 days post-dose. Healthy male and female participants, with no significant medical history, and in good health as determined by detailed medical history, full physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests; Body mass index (BMI) 18-32 kg/m2 and male weight ≥50 kg, and female weight ≥45 kg during the screening; Participants who signed the informed consent, and are considered reliable and capable of adhering to the protocol (e.g., able to understand), visit schedule, and medication intake according to the judgment of the investigator. Exclusion Criteria: 1) Recent use of any biological agents within 3 months before screening. Biological agents encompass a range of medicines derived from biological sources, including but not limited to some vaccines, growth factors, immune modulators, monoclonal antibodies, and products derived from human blood and plasma. 2) Recent use of prescription medicines, over-the-counter medicines, vitamins or supplements within 7 days, or 5 half-lives (whichever is longer) prior to dosing at the investigators' discretion. 3) Vaccination with live vaccine within 4 weeks prior to study drug administration, vaccination with an inactivated vaccination within 2 weeks prior to study drug administration, or intention to receive a live vaccine during the study period. 4) Participants who have received an investigational drug in the previous 90 days or 5 half-lives, whichever is longer, prior to Day 1 dosing. 5) Participants have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the participant if participating in this study. 6) Acute infection within 30 days prior to study drug administration. 7) Participants with active tuberculosis or latent tuberculosis, or those with history of previous tuberculosis infection. 8) Histories of lymphoproliferative disease within 5 years; current history of malignancy or a history of malignancy within 5 years (except for squamous cell carcinoma of the skin, basal cell carcinoma, and cervical cancer in situ after thorough treatment without any signs of recurrence). 9) Participants with a personal history of, or symptoms consistent with, inflammatory bowel disease (IBD). 10) Associated with an active infection, or with an infection history: a. Systemic anti-infective treatment 4 weeks before administration of study drug; b. Serious infection with hospitalization or intravenous anti-infective treatment within 8 weeks before administration of study drug; c. Recurrent, chronic or other active infections, which are assessed by the investigator to increase the risk of the participant. 11) Positive results of any of the following: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis B virus (HBV) deoxyribonucleic acid (DNA), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, interferon-gamma release assay (IGRA) or treponema pallidum particle agglutination (TPPA). 12) Female participants who are breastfeeding, pregnant, or male participants who plan to father children during the study. 13) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >1.5 times the upper limit of normal (ULN) at screening or Day -1; White cell count < 3.0; Neutrophil count < 2.0; Platelet count < 150. These tests can be repeated once at the investigator's discretion 14) Presence of any medical condition, mental health condition or suicidal ideation/behavior, which would make the participant unsuitable for inclusion in the study. 15) Participants who underwent major surgery within 8 weeks prior to baseline, or are planning to undergo major surgery during the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomei Yang
Phone
+86-10-58628288
Ext
9138
Email
xiaomei_yang@sinocelltech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Salman
Organizational Affiliation
Linear Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linear Clinical Research - Joonadalup
City
Joondalup
State/Province
Western Australia
ZIP/Postal Code
6027
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Nguyen
Phone
(08)63825100
Email
knguyen@linear.org.au
Facility Name
Linear Clinical Research - B Block
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Nguyen
Phone
(08)63825100
Email
knguyen@linear.org.au
Facility Name
Linear Clinical Research - Harry Perkins
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Nguyen
Phone
(08)63825100
Email
knguyen@linear.org.au

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers

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