NCT03917628

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2019

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 29, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2019

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

April 14, 2019

Last Update Submit

January 26, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (8)

  • 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.

  • 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.

  • 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.

  • λz

    Day 1 through Day 71

  • CL

    Day 1 through Day 71

  • +3 more secondary outcomes

Study Arms (2)

SCT630

EXPERIMENTAL

Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing SCT630

Drug: SCT630

adalimumab-EU source

ACTIVE COMPARATOR

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

Drug: adalimumab-EU source

Interventions

SCT630DRUG

SCT630 single s.c. injection

SCT630
adalimumab-EU sourceDRUG

adalimumab-EU source single s.c. injection

adalimumab-EU source

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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.
  • History of tuberculosis,positive test for Interferon-gamma-release assay,or suffering from active tuberculosis or latent tuberculosis infection.
  • History of malignancy of any type, other than surgically excised nonmelanomatous skin cancers, within 5 years prior to investigational product administration.
  • Positive test for HIV antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies at screening.
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients).
  • Quantification of Hepatitis B virus DNA is greater than the upper limit of normal value.
  • Received biologics or live vaccines ≤3 months prior to investigational product administration.
  • Intake of an investigational drug in another trial within three months prior to investigational product administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing SHIJITAN Hospital

Beijing, Beijing Municipality, 100038, China

Location

Study Design

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

Study Record Dates

First Submitted

April 14, 2019

First Posted

April 17, 2019

Study Start

May 29, 2019

Primary Completion

November 4, 2019

Study Completion

November 4, 2019

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

CN(1)