Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • LAE102 intravenous administration

    Drug

    A single dose of LAE102 administered intravenously

  • placebo intravenous administration

    Drug

    A single dose of placebo administered intravenously

  • LAE102 subcutaneous administration

    Drug

    Single dose of LAE102 administered subcutaneously

  • placebo subcutaneous administration

    Drug

    single dose of placebo administered subcutaneously

  • LAE102 multiple subcutaneous administration

    Drug

    Multiple dose of LAE102 administered subcutaneously

  • Placebo multiple subcutaneous administration

    Drug

    Multiple dose of placebo administered subcutaneously

Treatment groups

160 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A LAE102 IVExperimental treatment 1 intervention
Group B: Part A placebo IVPlacebo comparator 1 intervention
Group C: Part B LAE102 SCExperimental treatment 1 intervention
Group D: Part B placebo SCPlacebo comparator 1 intervention
Group E: Part C LAE102 SCExperimental treatment 1 intervention
Group F: Part C placebo SCPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number & severity of participants with treatment-related adverse events as assessed by CTCAE V5.0

Findings on physical examination, ECG, vital signs, and reports of the laboratory results based on the CTCAE v5.0

Time frame
From Day 1 to Day 29 for single dose part. From Day 1 to Day 196 for multiple dose part

Secondary outcomes

1

characterize the peak of serum concentration (Cmax) of LAE102 injection in healthy subjects

For both intravenously guttae \& subcutaneous injection, to evaluate the maximum observed serum concentration(Cmax)

Time frame
From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
2

characterize the area under the serum concentration versus time curve (AUC) of LAE102 injection in healthy subjects

For both intravenously guttae \& subcutaneous injection, to evaluate the area under the serum concentration versus time curve (AUC)

Time frame
From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
3

evaluate the expression levels of Activin A in blood samples

The validated methodology was employed to assay serum levels of Activin A in biological samples.

Time frame
From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.
4

Incidence of positive Anti-drug antibody(ADA) after administration

Test ADA status in biological sample via validated methodology

Time frame
pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part.

Other outcomes

1

Preliminary pharmacodynamic of total body weight for multiple dose part

Changes and percentage changes in total body weight (kg) after administration

Time frame
From pre-dose to Day 168.
2

Preliminary pharmacodynamic of lean mass for multiple dose part

Changes and percentage changes in lean mass after administration

Time frame
From pre-dose to Day 168.
3

Preliminary pharmacodynamic of fat mass for multiple dose part

Changes and percentage changes in fat mass after administration

Time frame
From pre-dose to Day 168.
4

Preliminary pharmacodynamic of thigh muscle volume for multiple dose part

Changes and percentage changes in thigh muscle volume after administration

Time frame
From pre-dose to Day 168

Sponsors and contacts

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

Laekna Limited

Lead sponsor

Source ClinicalTrials.gov
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