Pharmacokinetics and Safety in Healthy Volunteers

Sponsor
Sinocelltech Ltd.
Study ID
NCT03917628
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • SCT630 — DRUG
    SCT630 single s.c. injection
  • adalimumab-EU source — DRUG
    adalimumab-EU source single s.c. injection

Study Details

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

Key Dates

Start date
May 29, 2019
Status verified
Jan 2021
Primary completion
Nov 4, 2019
Completion
Nov 4, 2019

Study Design

Enrollment
146 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SCT630
    Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing SCT630
  • Active Comparator: adalimumab-EU source
    Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source

Primary Outcome Measure

AUC0-tz [ Time Frame: 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. ]

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