Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SLN12140

    Drug

    SLN12140 for sc injection or IV infusion

  • Placebo

    Other intervention

    Placebo for sc injection or IV infusion

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: SLN12140Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability of SLN12140

Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)

Time frame
36 days

Secondary outcomes

1

Pharmacokinetics-Cmax

Maximum Observed Plasma Concentration (Cmax)

Time frame
36 days
2

Pharmacokinetics-Tmax

Time at which the maximum plasma concentration (Cmax) occurs

Time frame
36 days
3

Pharmacokinetics-AUClast

Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration

Time frame
36 days
4

Pharmacokinetics-AUCinf

Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf)

Time frame
36 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Linno Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: