Early safety study of HXN-1013 in healthy adults and people with asthma
Tests HXN-1013 in healthy adults and adults with mild-to-moderate asthma.
Plain-language title generated from the registry record
Registry title: Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Key facts
- Where
- Bayswater, AustraliaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07900568, who can take part
Where in Australia
- Veritus ResearchBayswater, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Helixon Biotechnology (Suzhou) Co., Ltd
- Trial code
- NCT07900568
- Record updated
- 28 October 2026
- Original description
This is a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study evaluating HXN-1013 in healthy participants and participants with mild-to-moderate asthma.Read full original descriptionShow less
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HXN-1013 Following Subcutaneous Administration in Healthy Participants and Participants With Mild-to-Moderate Asthma
This is a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study evaluating HXN-1013 in healthy participants and participants with mild-to-moderate asthma.
Inclusion: Participants must be able to understand and comply with the study requirements and voluntarily sign the informed consent form (ICF); (Healthy participants) Male or female aged 18 to 55 years (inclusive) at signing of the ICF; (Healthy participants) Male participants weighing ≥ 50.0 kg or and female participants ≥ 45.0 kg, with a body mass index (BMI) between 18.0-32.0 kg/m² (inclusive); (Participants with asthma) Participants must have documented physician-diagnosed asthma for ≥12 months, pre-bronchodilator FEV1 ≥60% predicted, objective evidence of variable airflow limitation, and well-controlled disease (GINA) on permitted stable background therapy.
Exclusion: Active or suspected infection within 30 days prior to randomization; positive IGRA indicative of active tuberculosis; positive HIV, syphilis, HBsAg, or HCV antibody; Use of therapeutic antibodies within 5 half-lives prior to dosing; experimental agent within 30 days or 5 half-lives; live vaccines within 30 days or non-live vaccines within 14 days; History of malignancy within 5 years (except resected basal/squamous cell carcinoma of the skin); History of clinically significant hypersensitivity reactions (e.g., anaphylaxis, angioedema) to biologic agents or to study drug excipients; Pregnant or breastfeeding women; women planning pregnancy within 180 days after dosing; Clinically significant ECG abnormalities (e.g., QTcF ≥450 ms male / ≥470 ms female).