NL005 phase 1 safety and pharmacokinetics
A first-in-human, randomized, double-blind, single- and multiple-dose, phase I study of recombinant human thymosin β4 in healthy Chinese volunteers.
Wang X, Liu L, Qi L, Lei C, Li P, Wang Y, Liu C, Bai H, Han C, Sun Y, Liu J. · Journal of cellular and molecular medicine
Study record
- Population
Healthy adults aged 18–50: 54 in the single-dose study (44 active, 10 placebo); 30 in the multiple-dose study (24 active, six placebo).
Read source · Full-text reportMethods — Subjects; Results — Demographics- Formulation
NL005 recombinant human thymosin beta 4, described as 44 amino acids; 0.1 mg investigational vials from Beijing Northland Biotechnology, versus saline. This is not a TB-500 fragment.
Read source · Full-text reportIntroduction; Methods — Investigational products- Route
Intravenous administration in a clinical pharmacology unit.
Read source · Full-text reportMethods — Study design- Dose & frequency
Single-dose cohorts: 0.05, 0.25, 0.5, 2, 5, 12.5 or 25 μg/kg. Separate repeated-dose cohorts: 0.5, 2 or 5 μg/kg daily for 10 days. These are study exposures and establish no human or KLOW regimen for another product.
Read source · Full-text reportMethods — Study design; Multiple ascending doses- Study design
Single-center, randomized, double-blind dose-escalation studies. The two lowest single-dose cohorts had two active recipients each; later cohorts used an active-to-placebo ratio of 4:1.
Read source · Full-text reportMethods — Study design- Duration
Single administration or 10 consecutive daily administrations; follow-up through day 28.
Read source · Full-text reportMethods — Single ascending doses; Multiple ascending doses- Reported findings
Evaluated tolerability, pharmacokinetics and anti-drug antibodies, not clinical treatment efficacy. No serious adverse events or dose-limiting toxicities were reported.
Read source · Full-text reportResults — Safety; Pharmacokinetics; Immunogenicity- Adverse events
Any adverse event: 25/44 active versus 7/10 placebo in the single-dose study; 16/24 versus 5/6 in the repeated-dose study. Events were mild or moderate. One participant in each arm of the highest repeated-dose cohort left because of an abnormal ECG.
Read source · Full-text reportResults — Safety; Tables 2–3- Monitoring
Serial vital signs, examinations, blood counts, chemistry, cardiac markers, coagulation and ECGs; pharmacokinetic sampling and anti-drug antibody testing. Assessments extended through day 28.
Read source · Full-text reportMethods — Single ascending doses; Multiple ascending doses
What it supports
Short-term tolerability and pharmacokinetic observations for a specified recombinant investigational product in selected healthy adults.
What it does not establish
Small cohorts and short follow-up cannot establish long-term safety, wound healing or athletic benefit. NL005 is described as 44 amino acids, distinct from natural 43-amino-acid thymosin beta 4 and TB-500 fragments. The pharmacokinetic prose contains an apparent unrelated-drug naming error; no accumulation claim is reproduced here.
Funding
Beijing Northland Biotechnology sponsored the study; three authors were sponsor employees despite the general no-conflicts statement.
Literature search cutoff: 2026-09-08 · Not independently clinically reviewed
Browse study library