Pharmacokinetics and Safety in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: adalimumab-EU source; Drug: SCT630

• Registration Number: NCT03917628
• Lead Sponsor: Sinocelltech Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-14
• Study First Submitted QC: 2019-04-14
• Study First Posted: 2019-04-17
• Study Start: 2019-05-29
• Primary Completion: 2019-11-04
• Study Completion: 2019-11-04
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 146

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adalimumab-EU source	adalimumab-EU source	Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source
SCT630	SCT630	Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing SCT630

Primary Outcome Measures

Name	Time	Method
Cmax	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.	Maximum Concentration (Cmax) of SCT630 and EU-licensed Humira
AUC0-tz	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.	Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of SCT630 and EU-licensed Humira

Secondary Outcome Measures

Name	Time	Method
AUC 0-∞	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.	Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of SCT630 and EU-licensed Humira
λz	Day 1 through Day 71	λz of SCT630 and EU-licensed Humira
Vd	Day 1 through Day 71	Apparent volume of distribution (Vd) of the SCT630 and EU-licensed Humira
Tmax	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.	Time to the Maximum Concentration of SCT630 and EU-licensed Humira
CL	Day 1 through Day 71	Clearance rate of the SCT630 and EU-licensed Humira
Number (Proportion) of Subjects With Drug Related Adverse Events	Day 1 through Day 71
t1/2	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.	Elimination Phase Half-life of SCT630 and EU-licensed Humira
Positive rate of ADA and NAb	Day 1 through Day 71	Comparision of the positive rate of ADA and NAb between the SCT630 and EU-licensed Humira

Trial Locations

Locations (1)

Beijing SHIJITAN Hospital; 🇨🇳 Beijing, Beijing, China