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NCT05128409
Phase I of XKH001Injection in Healthy Adults
Phase 1 trial testing XKH001 Injection in Healthy Adults in 35 participants. Status unknown.
1 October 2024
Quick facts
| Lead sponsor | Beijing Kanova Biopharmaceutical Co., LTD |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | triple |
| Primary purpose | health services research |
| Enrollment | 35 |
| Start date | 7 March 2023 |
| Primary completion | 1 October 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- XKH001 Injection — full drug profile →
- XKH001Placebo Injection — full drug profile →
Conditions studied
- Healthy Adults — all drugs for Healthy Adults →
Sponsor
Beijing Kanova Biopharmaceutical Co., LTD — full company profile →
Who can join
Adults 18 to 65, any sex, with Healthy Adults. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
XKH001is a recombinant humanized monoclonal IgG1 antibody for subcutaneous injection. XKH001 specifically blocks interleukin-25 from binding to its receptors. To evaluate the safety, tolerability, pharmacokinetics (PK) of single ascending doses of XKH001 injection following subcutaneous administration
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
New insights into the function of Interleukin-25 in disease pathogenesis.
Yuan Q, Peng N, Xiao F, Shi X, et al · · 2023 · cited 29× · PMID 37005677 · DOI 10.1186/s40364-023-00474-9 -
Regulation of Airway Epithelial-Derived Alarmins in Asthma: Perspectives for Therapeutic Targets.
Hansi RK, Ranjbar M, Whetstone CE, Gauvreau GM. · · 2024 · cited 7× · PMID 39457624 · DOI 10.3390/biomedicines12102312 -
Evaluation of the safety, tolerability, pharmacokinetics and pharmacodynamics of SM17 in healthy volunteers: results from pre-clinical models and a first-in-human, randomized, double blinded clinical trial.
Xu G, Paglialunga S, Qian X, Ding R, et al · · 2024 · cited 6× · PMID 39717777 · DOI 10.3389/fimmu.2024.1495540 -
The clinical efficacy of type 2 monoclonal antibodies in eosinophil-associated chronic airway diseases: a meta-analysis.
Wu Y, Huang M, Zhong J, Lu Y, et al · · 2023 · cited 4× · PMID 37114057 · DOI 10.3389/fimmu.2023.1089710
Verify or expand the search:
- PubMed search for NCT05128409
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of XKH001 Injection
Trials testing the same drug.
- NCT07054736 — Evaluate the Efficacy and Safety of XKH001 Injection in Patients With Moderate-to-Severe Atopic Dermatitis · Phase 2 · not yet recruiting
- NCT07070297 — A Single-Arm Phase Ic Clinical Study of XKH001 Injection in Patients With Allergic Asthma After Multiple Doses · Phase 1 · completed
- NCT05991661 — XKH001 Injection in Healthy Subjects · Phase 1, PHASE2 · completed
Other recruiting trials for Healthy Adults
Currently open trials in the same condition.
- NCT07454551 — The Comparison of Different Passive Warm-Up Methods Prior to Exercise · NA · recruiting
- NCT07431853 — A Study to Learn About mRNA Vaccines Against Influenza in Adults · Phase 2 · recruiting
- NCT07362550 — Effects of 12-Week Balanced Diet on Body Composition & Metabolic Parameters in Twins · NA · recruiting
- NCT07284173 — A Study to Learn if a Medicine That Reduces Stomach Acid Affects the Blood Level of Study Medicine PF-08049820 in Health · Phase 1 · active not recruiting
- NCT07518758 — Acute Effect of Polyphenols Supplementation on Endothelial Function and Exercise Related Markers, in Physically Active H · NA · active not recruiting
Other Beijing Kanova Biopharmaceutical Co., LTD trials
Trials by the same sponsor.
- NCT05991661 — XKH001 Injection in Healthy Subjects · Phase 1, PHASE2 · 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 NCT05128409 (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 Beijing Kanova Biopharmaceutical Co., LTD
- Last refreshed: 12 April 2023
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/NCT05128409.
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