deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT03357939

Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects

A Phase 1 Randomized,Double-Blind and Parallel Controlled Single-dose Clinical Trial of Pharmacokinetics, Safety, Tolerability and Immunogenicity of HLX03 Compared With Humira® From China Source in Chinese Healthy Male Subjects

Sponsor: Shanghai Henlius Biotech

Interventions HLX03 adalimumab
Updated 8 times since 2017 Last updated: May 4, 2022 Started: Jan 12, 2017 Primary completion: Sep 15, 2018 Completion: Sep 15, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Immune System Disorder and is currently completed. Shanghai Henlius Biotech leads this study, which shows 8 recorded versions since 2017 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Dec 2017 – ~Dec 2019 · 24 months · monthly snapshotActive Not Recruiting~Dec 2019 – ~Dec 2020 · 12 months · monthly snapshotUnknown Status~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshotCompleted~Jan 2021 – ~Jun 2022 · 17 months · monthly snapshotCompleted~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jun 2022 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jan 2021 — Jun 2022 [monthly]

    Completed PHASE1

Show 3 earlier versions
  1. Dec 2020 — Jan 2021 [monthly]

    Completed PHASE1

    Status: Unknown StatusCompleted

  2. Dec 2019 — Dec 2020 [monthly]

    Unknown Status PHASE1

    Status: Active Not RecruitingUnknown Status

  3. Dec 2017 — Dec 2019 [monthly]

    Active Not Recruiting PHASE1

    First recorded

Jan 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shanghai Henlius Biotech
Data source: Shanghai Henlius Biotech

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations