This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.
| Registry number | NCT04555850 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Sponsor | Beijing Northland Biotech. Co., Ltd. |
| Enrollment | 30 participants |
| Design | Interventional, Randomized, Parallel, Masking: Quadruple |
| Conditions | Healthy |
| Interventions | Recombinant Human Thymosin β4; Placebo |
| Start | Jul 30, 2018 |
| Primary completion | Feb 18, 2019 |
| Study completion | Jul 26, 2019 |
| Results posted | Not yet |
| Registry last updated | Sep 29, 2020 |
Compounds on this site that cite this trial
What the registry says the trial is about
The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or placebo 0.5, 2.0,5.0μg/kg in Chinese healthy volunteers.30 volunteers will be randomly assigned to one of three groups to receive either NL005 or placebo for 10 consecutive days.
Primary outcomes
These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.
| Outcome measure | Time frame |
|---|---|
| Maximum Tolerated Dose (MTD) . | Day-7u3001-1u30011u30012u30013u30014u30015u30016u30017u30018u30019u300110u300114u300128. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.03. | Day-7u3001-1u30011u30012u30013u30014u30015u30016u30017u30018u30019u300110u300114u300128. |
| The Cmax of multiple administration of rh-Tu03b24. | Day 1u30012u30013u30014u30015u30016u30017u30018u30019u300110. |
| The Tmax of multiple administration of rh-Tu03b24. | Day 1u30012u30013u30014u30015u30016u30017u30018u30019u300110. |
| The MRT of multiple administration of rh-Tu03b24. | Day 1u30012u30013u30014u30015u30016u30017u30018u30019u300110. |
| The AUClast of multiple administration of rh-Tu03b24. | Day 1u30012u30013u30014u30015u30016u30017u30018u30019u300110. |
| The AUC0-inf of multiple administration of rh-Tu03b24. | Day 1u30012u30013u30014u30015u30016u30017u30018u30019u300110. |
| The t1/2 of multiple administration of rh-Tu03b24. | Day 1u30012u30013u30014u30015u30016u30017u30018u30019u300110. |
| The VZ of multiple administration of rh-Tu03b24. | Day 1u30012u30013u30014u30015u30016u30017u30018u30019u300110. |
| The CL of multiple administration of rh-Tu03b24. | Day 1u30012u30013u30014u30015u30016u30017u30018u30019u300110. |
| The potential immunological reaction (antibody formation) of multiple administration of rh-Tu03b24. | Day 1u300114u300128. |
Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 3, 2026. See the trial changes feed for what has changed recently.
