Health TrialsbyHealthPanel

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants

ConditionOverweight and Obesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLaekna Limited

About this trial

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE103 injection in healthy overweight/obese participants or healthy postmenopausal women. Study will also evaluate the safety, tolerability and preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants.

In addition, the study will also investigate the safety, tolerability of a single-dose co-administration of LAE102 and LAE103 in healthy overweight/obese participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Informed consent: Are capable of giving signed informed consent and comply with the requirements and restrictions listed in the ICF and in this protocol.

Parts A, C, and D: Male or female participants aged 18 to 55 years, inclusive. Each cohort must include at least 3 female and 3 male participants.

Part B: Female participants aged 45 to 75 years, inclusive.

Parts A, C, and D: Have a BMI within the range of 25.0 to 40.0 kg/m2 (inclusive).

Disqualifiers

Informed consent: Are capable of giving signed informed consent and comply with the requirements and restrictions listed in the ICF and in this protocol.

Parts A, C, and D: Male or female participants aged 18 to 55 years, inclusive. Each cohort must include at least 3 female and 3 male participants.

Part B: Female participants aged 45 to 75 years, inclusive.

Parts A, C, and D: Have a BMI within the range of 25.0 to 40.0 kg/m2 (inclusive).

Trial design

Design model

Parallel

Treatments tested in this trial

  • LAE103 injection

    Drug

    subcutaneous injection of LAE103 alone

  • LAE102 injection in combined with LAE103 injection

    Drug

    LAE102 injection in combined with LAE103 injection via subcutaneous

  • Saline

    Drug

    Saline via subcutaneous

  • 102 placebo + saline

    Combination product

    LAE102 injection without active ingredient combined with saline injection

Treatment groups

104 Participants
are divided into 4 treatment groups
Group A: Treatment arm of single drugExperimental treatment 1 intervention
Group B: comparator armPlacebo comparator 1 intervention
Group C: Treatment arm of combinationExperimental treatment 1 intervention
Group D: 102 placebo+ salinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number & severity of participants with treatment-related adverse events

Findings on physical examination, ECG, vital signs, and reports of the laboratory results via investigator assessment

Time frame
From Day1 to Day112 for single dose part.From Day1 to Day84 for Combination Drug Part. From Day 1 to Day140 for multiple dose part.

Secondary outcomes

1

characterize the peak of serum concentration (Cmax)

evaluate the maximum observed serum concentration(Cmax) via LAE103 injection mono or LAE102 combined with LAE103 injection

Time frame
From Day1 to Day112 for single dose part.From Day1 to Day 84 for Combination Drug Part. From Day 1 to Day140 for multiple dose part.
2

characterize the time of reaching peak of serum concentration (Tmax)

evaluate what time to reach the maximum serum concentration(Tmax)

Time frame
From Day1 to Day112 for single dose part.From Day 1 to Day 84 for Combination Drug Part. From Day 1 to Day140 for multiple dose part.
3

characterize the area under the serum concentration versus time curve (AUC)

Evaluate the area under the serum concentration versus time curve (AUC) in LAE103 mono injection or LAE102 combined with LAE103 injection

Time frame
From Day1 to Day112 for single dose part.From Day1 to Day 84 for Combination Drug Part. From Day 1 to Day140 for multiple dose part.
4

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 Day1 to Day112 for single dose part.From Day 1 to Day 84 for Combination Drug Part. From Day 1 to Day140 for multiple dose part.

Other outcomes

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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