Pharmacokinetics and Safety in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2019-11-04

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SCT630

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

Group Type EXPERIMENTAL

SCT630

Intervention Type DRUG

SCT630 single s.c. injection

adalimumab-EU source

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

Group Type ACTIVE_COMPARATOR

adalimumab-EU source

Intervention Type DRUG

adalimumab-EU source single s.c. injection

Interventions

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SCT630

SCT630 single s.c. injection

Intervention Type DRUG

adalimumab-EU source

adalimumab-EU source single s.c. injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes