Last reviewed · How we verify
NCT04561076
Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers
Phase 1 trial testing HLX70 in COVID 19. Withdrawn.
6 September 2021
Quick facts
| Lead sponsor | Hengenix Biotech Inc |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | other |
| Start date | 9 December 2020 |
| Primary completion | 6 September 2021 |
| Estimated completion | 18 September 2021 |
Drugs / interventions tested
- HLX70 — full drug profile →
- Placebo
Conditions studied
- COVID 19 — all drugs for COVID 19 →
Sponsor
Hengenix Biotech Inc — full company profile →
Who can join
Adults 18 to 60, any sex, with COVID 19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Phase I Clinical Study to Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neutralizing monoclonal antibodies for treatment of COVID-19.
Taylor PC, Adams AC, Hufford MM, de la Torre I, et al · · 2021 · cited 604× · PMID 33875867 · DOI 10.1038/s41577-021-00542-x -
SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, et al · · 2021 · cited 126× · PMID 34473343 · DOI 10.1002/14651858.cd013825.pub2 -
Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline.
Tuccori M, Ferraro S, Convertino I, Cappello E, et al · · 2020 · cited 124× · PMID 33319649 · DOI 10.1080/19420862.2020.1854149 -
A Detailed Overview of Immune Escape, Antibody Escape, Partial Vaccine Escape of SARS-CoV-2 and Their Emerging Variants With Escape Mutations.
Chakraborty C, Sharma AR, Bhattacharya M, Lee SS. · · 2022 · cited 112× · PMID 35222380 · DOI 10.3389/fimmu.2022.801522 -
Neutralizing antibodies targeting SARS-CoV-2 spike protein.
Xiaojie S, Yu L, Lei Y, Guang Y, et al · · 2021 · cited 99× · PMID 33341604 · DOI 10.1016/j.scr.2020.102125 -
COVID-19 antibodies on trial.
DeFrancesco L. · · 2020 · cited 88× · PMID 33087898 · DOI 10.1038/s41587-020-0732-8 -
COVID-19 update: The race to therapeutic development.
Twomey JD, Luo S, Dean AQ, Bozza WP, et al · · 2020 · cited 50× · PMID 33161277 · DOI 10.1016/j.drup.2020.100733 -
Emerging mutations in the SARS-CoV-2 variants and their role in antibody escape to small molecule-based therapeutic resistance.
Chakraborty C, Bhattacharya M, Sharma AR. · · 2022 · cited 33× · PMID 34920267 · DOI 10.1016/j.coph.2021.11.006
Verify or expand the search:
- PubMed search for NCT04561076
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HLX70
Trials testing the same drug.
- NCT05429385 — Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers · Phase 1 · withdrawn
Other recruiting trials for COVID 19
Currently open trials in the same condition.
- NCT06871293 — Evaluating the Impact of a Functional and Cognitive Strategy in Patients With Long Covid-19 · NA · recruiting
- NCT06599658 — COVID-19 Booster and IIV Schedule in Immunocompromised Hosts · Phase 2 · recruiting
- NCT04359836 — A Study to Explore the Role of Gut Flora in COVID-19 Infection · recruiting
- NCT04522076 — Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acq · active not recruiting
- NCT06702540 — Bio-reconfigurable Electronic Platform for Multiplex Detection of Viral Respiratory Pathogens · active not recruiting
Other Hengenix Biotech Inc trials
Trials by the same sponsor.
- NCT04583228 — Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of HLX71 (Recombinant Human An · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04561076 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hengenix Biotech Inc
- Last refreshed: 1 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04561076.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing