Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers

NCT05894707 | Unknown Phase 1

• 1 other identifier: SCT650C-612-1-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of clinical trial is to evaluate the safety and tolerability of SCT650C in healthy participants.

Conditions

Autoimmune Disease

Keywords

IL-17A monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 1, IP administration) up to 24 weeks

Secondary Outcomes (4)

• Percentage of participants with at least one treatment-emergent serious adverse event (SAE)

  Baseline (Day 1, IP administration) up to 24 weeks

• Peak Plasma Concentration (Cmax) of SCT650C

  Baseline (Day -1 predose) up to 24 weeks

• Area under the plasma concentration versus time curve (AUC) of SCT650C

  Baseline (Day -1 predose) up to 24 weeks

• The level of anti-drug antibodies (ADA) to SCT650C

  Baseline (Day -1 predose) up to 24 weeks

Study Arms (4)

80 mg SCT650C or normal saline

EXPERIMENTAL

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

Drug: SCT650C

160 mg SCT650C or normal saline

EXPERIMENTAL

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

Drug: SCT650C

40 mg SCT650C or normal saline

EXPERIMENTAL

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

Drug: SCT650C

20 mg SCT650C or normal saline

EXPERIMENTAL

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

Drug: SCT650C

Interventions

SCT650C DRUG

Recombinant anti-IL-17A antibody

Also known as: Recombinant anti-IL-17A antibody

160 mg SCT650C or normal saline; 20 mg SCT650C or normal saline; 40 mg SCT650C or normal saline; 80 mg SCT650C or normal saline

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• \) 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.
• \) 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.
• \) 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.
• \) Participants who have received an investigational drug in the previous 90 days or 5 half-lives, whichever is longer, prior to Day 1 dosing.
• \) 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.
• \) 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.
• \) 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).
• \) Participants with a personal history of, or symptoms consistent with, inflammatory bowel disease (IBD).
• \) 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.
• \) 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).
• \) Female participants who are breastfeeding, pregnant, or male participants who plan to father children during the study.
• \) Participants who underwent major surgery within 8 weeks prior to baseline, or are planning to undergo major surgery during the study.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (3)

Linear Clinical Research - Joonadalup

Joondalup, Western Australia, 6027, Australia

Location

Linear Clinical Research - B Block

Nedlands, Western Australia, 6009, Australia

Location

Linear Clinical Research - Harry Perkins

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Sam Salman

  Linear Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomei Yang

CONTACT

+86-10-58628288; xiaomei_yang@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 8, 2023
• Study Start: June 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: March 1, 2024
• Last Updated: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)