New antibody for lung scarring passes first safety check in healthy volunteers
NCT ID NCT06310746
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested a single dose of HLX6018, an experimental antibody, in 66 healthy adults to see if it is safe and how the body handles it. HLX6018 is designed to block a protein pathway involved in idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs. Because this is the first human trial, it only looks at safety and drug levels—not whether it actually treats IPF.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HLX6018 (a monoclonal antibody that targets GARP/TGF-β1)
- What this could lead to
- If this early safety study goes well, it could pave the way for testing HLX6018 as a potential treatment for idiopathic pulmonary fibrosis (IPF), a serious lung disease.
- What could go wrong
- This is a very early Phase 1 trial in healthy people, not patients. It only checks safety and dosing—not whether the drug works for IPF. Many drugs fail in later stages.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
66 people
The number who actually took part.
- Started
-
Apr 2024
- Finished
-
Jul 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Fully informed about the nature, significance, potential inconveniences, and associated risks of the study prior to enrollment. Comprehend the study's procedures and methodology, agree to follow the clinical study protocol, and give voluntary written informed consent; 2. 18-55 years old, including the boundary value, male or female; 3. Body weight: 45-85 kg for females and 50-85 kg for males, including the boundary value; body mass index (BMI): 18.0-28.0 kg/m2 , including the boundary value, (BMI = body weight (kg)/body height2 (m2)); 4. Subjects, including males, must have no childbearing plan and take effective contraceptive measures from the time of informed consent to 6 months after the administration of the study drug. 5. Physical examinations and vital signs should be normal or abnormal without clinical significance. Exclusion Criteria: 1. Any clinically significant laboratory test abnormalities or, within 12 months before screening, any other clinically significant clinical findings indicative of diseases, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular conditions; 2. Donation/loss of ≥ 450 mL of blood or receipt of blood transfusion or use of blood products within 3 months prior to screening, or planning to donate blood during the study or within 1 month after the end of the study; 3. Patients with severe trauma or major surgery within 3 months before screening, or planning to undergo surgery during the study; 4. Patients who smoke more than 5 cigarettes per day in the 3 months before screening; 5. History of drug abuse or addiction or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
First Hospital of Jilin University
Changchun, Jilin, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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