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 | NCT04555824 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Sponsor | Beijing Northland Biotech. Co., Ltd. |
| Enrollment | 54 participants |
| Design | Interventional, Randomized, Parallel, Masking: Quadruple |
| Conditions | Healthy |
| Interventions | Recombinant Human Thymosin β4; Placebo |
| Start | Jul 17, 2017 |
| Primary completion | Feb 20, 2018 |
| Study completion | Jun 20, 2018 |
| 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 0.05, 0.25, 0.5, 2, 5, 12.5, 25μg/kg in Chinese healthy volunteers. 54 volunteers will be randomized to receive NL005 or placebo for 7 cohorts,administered iv by iv push on Day 1.
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) . | Day1 |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.03. | Day1 |
| The Cmax of single ascending doses of rh-Tu03b24. | Day 1. |
| The Tmax of single ascending doses of rh-Tu03b24. | Day 1. |
| The MRT of single ascending doses of rh-Tu03b24. | Day 1. |
| The AUClast of single ascending doses of rh-Tu03b24. | Day 1. |
| The AUC0-inf of single ascending doses of rh-Tu03b24. | Day 1. |
| The t1/2 of single ascending doses of rh-Tu03b24. | Day 1. |
| The VZ of single ascending doses of rh-Tu03b24. | Day 1. |
| The CL of single ascending doses of rh-Tu03b24. | Day 1. |
| The potential immunological reaction (antibody formation) of single ascending doses 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.
