Pharmacokinetics and Safety in Healthy Volunteers

Healthy Clinical Trial

Official title:

Pharmacokinetics and Safety of SCT630 in Healthy Subjects: a Randomized, Double-blind, Single Dose Clinical Phase I Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917628
• Other study ID #: SCT630PS01
• Status: Completed
• Phase: Phase 1
• Start date: May 29, 2019
• Est. completion date: November 4, 2019

Study information

• Verified date: January 2021
• Source: Sinocelltech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: November 4, 2019
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• SCT630
SCT630 single s.c. injection
• adalimumab-EU source
adalimumab-EU source single s.c. injection

Locations

Country	Name	City	State
China	Beijing SHIJITAN Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sinocelltech Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-tz	Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of SCT630 and EU-licensed Humira	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.
Primary	Cmax	Maximum Concentration (Cmax) of SCT630 and EU-licensed Humira	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	AUC 0-8	Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-8) of SCT630 and EU-licensed Humira	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	Tmax	Time to the Maximum Concentration of SCT630 and EU-licensed Humira	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	t1/2	Elimination Phase Half-life of SCT630 and EU-licensed Humira	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	?z	?z of SCT630 and EU-licensed Humira	Day 1 through Day 71
Secondary	CL	Clearance rate of the SCT630 and EU-licensed Humira	Day 1 through Day 71
Secondary	Vd	Apparent volume of distribution (Vd) of the SCT630 and EU-licensed Humira	Day 1 through Day 71
Secondary	Number (Proportion) of Subjects With Drug Related Adverse Events		Day 1 through Day 71
Secondary	Positive rate of ADA and NAb	Comparision of the positive rate of ADA and NAb between the SCT630 and EU-licensed Humira	Day 1 through Day 71