Study of SLN12140 in Healthy Adult Participants
ConditionHealthy Volunteer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLinno Pharmaceuticals, Inc.
About this trial
A randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SLN12140 in healthy participants with single subcutaneous/intravenous dose escalation and multiple subcutaneous administrations
Eligibility criteria
Qualifiers
Voluntarily participate in clinical trials and sign written informed consent, and be able to complete the whole trial process according to the requirements of the trial.
Persons of any gender, aged between 18 and 65 years old (including the boundary value).
Weight: male ≥50kg , female ≥45kg ; Body mass index (BMI) within the range of 19.0 to 28.0 kg/m2 (including cut-off values).
Those whose medical history, physical examination, vital signs examination, electrocardiogram examination, laboratory examination indicators, and anteroposterior chest X-ray are all normal or abnormal but non clinically significant as judged by the investigator.
Disqualifiers
Have cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic or nervous system diseases that affect the absorption, distribution, metabolism or elimination of drugs; or those with disease or medical history that may interfere with the interpretation of study data.
Those who have any previous history of Neisseria meningitidis.
Those who have a positive skin test for penicillin. Those who have known allergies or contraindications to penicillin or any vaccine ingredients, or who are known to be allergic to the trial drug and any of its ingredients or related preparations, or who have any history of allergies to food, drugs, or allergic diseases or allergies.
Those who have or are suspected of having any active viral, bacterial, fungal or parasitic infection, or receiving any anti-infective treatment within 1 month prior to screening.
Trial design
Treatments tested in this trial
- SLN12140
- Placebo
Treatment groups
56 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov