NCT07900568Not yet recruitingPhase 1
Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 21 Oct 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 15 Feb 2028
- Lead sponsor
- Helixon Biotechnology (Suzhou) Co., Ltd
- Diseases
- Asthma
- NCT number
- NCT07900568
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 1 Dec 2026 to the primary completion date, 15 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Veritus Research Coordinator of this site? Confirm its status | Bayswater | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.