Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2025
Translational Investigation of CM326 from Preclinical Studies to Randomized Phase I Clinical Trials in Healthy Adults.
Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1, Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CM326 in Adult Healthy Volunteers
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Multiple Ascending Doses of CM326 Injection by Subcutaneous Administration in Healthy Subjects
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Immunogenicity of CM326 Injection in Healthy Subjects
Who cites it
3 citing papers in PubMed.
- An anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial.Nature communications · 2025Trial
- Review
- Potential of alarmin-targeted bispecific and combination therapies in airway disease.Frontiers in allergy · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThymic stromal lymphopoietin (TSLP) plays a pivotal role in immune responses. CM326 is a humanized monoclonal antibody targeting TSLP.
objectiveThe aim of this study was to evaluate the preclinical characterization, safety, tolerability, pharmacokinetics, and immunogenicity of CM326 in healthy adults.
methodsIn vitro pharmacologic activity of CM326 was compared with that of tezepelumab. In vivo efficacy of CM326 was assessed in allergic cynomolgus monkeys. Subjects in single ascending dose trials were randomized 2:1 (22 mg), 4:1 (55/110/220/440/660/880 mg), and 3:1 (330 mg) to receive CM326 or placebo subcutaneously. Subjects in multiple ascending dose trials were randomized 4:1 (55/110/220 mg every 2 weeks [Q2W], 220 mg Q4W) and 3:1 (440 mg Q2W) to receive CM326 or placebo.
resultsCM326 revealed higher potency over tezepelumab in blocking T
conclusionsCM326 improved T CLINICAL
trial registrationClinicalTrials.gov identifiers: NCT04842201 (registered on 8 April 2021), NCT05171348 (registered on 9 December 2021), NCT05715333 (registered on 27 January 2023).
Indexed as
Identifiers
40185989What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.