Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05894707




Registration number
NCT05894707
Ethics application status
Date submitted
29/05/2023
Date registered
8/06/2023
Date last updated
8/06/2023

Titles & IDs
Public title
Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers
Scientific title
A Randomized, Double-blinded, Dose-escalation Phase Ia Study to Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers
Secondary ID [1] 0 0
SCT650C-612-1-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autoimmune Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SCT650C

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

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

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

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


Treatment: Drugs: SCT650C
Recombinant anti-IL-17A antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timepoint [1] 0 0
Baseline (Day 1, IP administration) up to 24 weeks
Secondary outcome [1] 0 0
Percentage of participants with at least one treatment-emergent serious adverse event (SAE)
Timepoint [1] 0 0
Baseline (Day 1, IP administration) up to 24 weeks
Secondary outcome [2] 0 0
Peak Plasma Concentration (Cmax) of SCT650C
Timepoint [2] 0 0
Baseline (Day -1 predose) up to 24 weeks
Secondary outcome [3] 0 0
Area under the plasma concentration versus time curve (AUC) of SCT650C
Timepoint [3] 0 0
Baseline (Day -1 predose) up to 24 weeks
Secondary outcome [4] 0 0
The level of anti-drug antibodies (ADA) to SCT650C
Timepoint [4] 0 0
Baseline (Day -1 predose) up to 24 weeks

Eligibility
Key inclusion criteria
1. 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.

2. 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;

3. Body mass index (BMI) 18-32 kg/m2 and male weight =50 kg, and female weight =45 kg
during the screening;

4. 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Joonadalup - Joondalup
Recruitment hospital [2] 0 0
Linear Clinical Research - B Block - Nedlands
Recruitment hospital [3] 0 0
Linear Clinical Research - Harry Perkins - Nedlands
Recruitment postcode(s) [1] 0 0
6027 - Joondalup
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sinocelltech Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The goal of clinical trial is to evaluate the safety and tolerability of SCT650C in healthy
participants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05894707
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Salman
Address 0 0
Linear Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xiaomei Yang
Address 0 0
Country 0 0
Phone 0 0
+86-10-58628288
Fax 0 0
Email 0 0
xiaomei_yang@sinocelltech.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05894707