Clinical trial NCT03917628: Pharmacokinetics and Safety in Healthy Volunteers
Official title: Pharmacokinetics and Safety of SCT630 in Healthy Subjects: a Randomized, Double-blind, Single Dose Clinical Phase I Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Sinocelltech Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-17
Enrollment: 146
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigate the pharmacokinetics, safety and tolerability of SCT630 and to establish pharmacokinetic similarity of SCT630 to adalimumab.


Eligibility criteria: Inclusion Criteria:

1. Male subjects aged 18 to 45 years
2. Body mass index (BMI) between 19 and 26 kg/m2
3. Normal or clinically acceptable physical examination, clinical laboratory values, ECG, chest X-ray and vital signs at screening and baseline.
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Exclusion Criteria:

1. History or evidence of a clinically significant disorder, condition, or disease that would have posed a risk to subject safety or would have interfered with the study evaluation, procedures, or study completion in the opinion of the investigator.
2. Evidence of any bacterial, viral, parasitic, systemic fungal infections, or infections due to other opportunistic pathogens within the 30 days prior to investigational product administration.
3. History of tuberculosis,positive test for Interferon-gamma-release assay,or suffering from active tuberculosis or latent tuberculosis infection.
4. History of malignancy of any type, other than surgically excised nonmelanomatous skin cancers, within 5 years prior to investigational product administration.
5. Positive test for HIV antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies at screening.
6. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients).
7. Quantification of Hepatitis B virus DNA is greater than the upper limit of normal value.
8. Received biologics or live vaccines ≤3 months prior to investigational product administration.
9. Intake of an investigational drug in another trial within three months prior to investigational product administration.

Primary outcomes:
measure: AUC0-tz
timeFrame: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
measure: Cmax
timeFrame: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
Secondary outcomes:
measure: AUC 0-∞
timeFrame: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
measure: Tmax
timeFrame: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
measure: t1/2
timeFrame: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
measure: λz
timeFrame: Day 1 through Day 71
measure: CL
timeFrame: Day 1 through Day 71
measure: Vd
timeFrame: Day 1 through Day 71
measure: Number (Proportion) of Subjects With Drug Related Adverse Events
timeFrame: Day 1 through Day 71
measure: Positive rate of ADA and NAb
timeFrame: Day 1 through Day 71
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing SHIJITAN Hospital
state: Beijing
Study officials:
References: