Evaluate LAE102 in Healthy and Overweight/Obese Subjects
ConditionOverweight and Obese Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLaekna Limited
About this trial
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE102 injection in healthy and overweight/obese participants, and also evaluate the preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants.
Eligibility criteria
Qualifiers
Male or female and aged 18 to 65 years (inclusive) at the screening visit
Male Body weight ≥ 50 kg, female Body weight ≥ 45 kg. For Part A&B, 18.5 ≤ BMI ≤ 28 kg/m². For part C, 26.0 ≤ BMI ≤ 40.0 kg/m²
Negative for human immunodeficiency virus antibody (HIV-Ab).
Female subjects with no childbearing potential or with childbearing potential which serum human chorionic gonadotropin (hCG) test must <5mIU/mL .
Disqualifiers
With clinically significant abnormalities in vital signs, physical examination, ECG or laboratory test results specified in the protocol.
Allergy to the investigational drug or its excipients, or a history of severe allergy (including any food or drug allergies).
Self-reported weight change is more than 5% in the previous 3 months prior to screening.
Diagnosed with secondary overweight or obesity.
Trial design
Treatments tested in this trial
- LAE102 intravenous administration
- placebo intravenous administration
- LAE102 subcutaneous administration
- placebo subcutaneous administration
- LAE102 multiple subcutaneous administration
- Placebo multiple subcutaneous administration
Treatment groups
160 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov