Evaluate LAE102 in Healthy and Overweight/Obese Subjects

NCT06493084 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LAE102CN1001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obese Volunteers

Outcome Measures

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

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

Secondary Outcomes (4)

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

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

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

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

• evaluate the expression levels of Activin A in blood samples

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

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

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

Other Outcomes (6)

• Preliminary pharmacodynamic of total body weight for multiple dose part

  From pre-dose to Day 168.

• Preliminary pharmacodynamic of lean mass for multiple dose part

  From pre-dose to Day 168.

• Preliminary pharmacodynamic of fat mass for multiple dose part

  From pre-dose to Day 168.

Study Arms (6)

Part A LAE102 IV

EXPERIMENTAL

Single dose LAE102 by IV administration

Drug: LAE102 intravenous administration

Part A placebo IV

PLACEBO COMPARATOR

Single dose placebo by IV administration

Drug: placebo intravenous administration

Part B LAE102 SC

EXPERIMENTAL

Single dose LAE102 by SC administration

Drug: LAE102 subcutaneous administration

Part B placebo SC

PLACEBO COMPARATOR

Single dose placebo by SC administration

Drug: placebo subcutaneous administration

Part C LAE102 SC

EXPERIMENTAL

Multiple dose LAE102 by SC administration

Drug: LAE102 multiple subcutaneous administration

Part C placebo SC

PLACEBO COMPARATOR

Multiple dose placebo by SC administration

Drug: Placebo multiple subcutaneous administration

Interventions

placebo subcutaneous administration DRUG

single dose of placebo administered subcutaneously

Also known as: Placebo SC

Part B placebo SC

LAE102 multiple subcutaneous administration DRUG

Multiple dose of LAE102 administered subcutaneously

Also known as: LAE102 SC

Part C LAE102 SC

Placebo multiple subcutaneous administration DRUG

Multiple dose of placebo administered subcutaneously

Also known as: Placebo SC

Part C placebo SC

LAE102 intravenous administration DRUG

A single dose of LAE102 administered intravenously

Also known as: LAE102 IV

Part A LAE102 IV

placebo intravenous administration DRUG

A single dose of placebo administered intravenously

Also known as: Placebo IV

Part A placebo IV

LAE102 subcutaneous administration DRUG

Single dose of LAE102 administered subcutaneously

Also known as: LAE102 SC

Part B LAE102 SC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .
• Male subjects are not allowed to donate sperm during this trial.
• Voluntarily participate in the study and provide a signed and dated informed consent form.
• Willing to comply with the scheduled visits, study treatment, laboratory tests, and other study-related procedures and requirements as stipulated in the study protocol.

You may not qualify if:

• 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.
• Any clinically significant medical conditions and any diseases affecting the safety of the subject or the determination of study results.
• History of major diseases or physical conditions in the central nervous system, respiratory system, cardiovascular system, digestive system, blood system, endocrine system, musculoskeletal diseases, mental illness, urinary system, or tumors, or any existing acute diseases, or other diseases or physical conditions that may affect the study or pose an unacceptable risk to the subjects.
• Positive for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or syphilis spirochete antibody (TP-Ab).
• Known or suspected history of substance abuse or positive drug screening test.
• Alcohol abuse within 1 year before screening or positive alcohol breath test at baseline.
• Smoking more than 5 cigarettes per day within 3 months before screening, or unable to comply with the prohibition of smoking during the study period.
• Received any vaccine within 30 days prior to screening, or planned to receive any vaccine during the study period.
• Inability to ensure no use of any drugs, including prescription and non-prescription drugs (excluding paracetamol, ibuprofen, and topically applied eye/nasal drops and ointments with no systemic exposure risk), vitamins, supplements and herbal medicines, from 14 days before the initial administration (if the half-life of the drug used exceeds 14 days, then 5 half-lives shall apply) until the last visit period.
• Participated in any clinical trial and received an investigational medicine or medical device within 3 months prior to dosing of the investigational product.
• Underwent major surgery within 30 days before the initial administration or planned to undergo major surgery during the study period.
• Donated blood or experienced blood loss ≥400 mL within 3 months before screening or received a blood transfusion.

Sponsors & Collaborators

• Laekna Limited: lead

Study Sites (1)

Fudan Zhongshan Hospital

Shanghai, Shanghai Municipality, 201203, China

RECRUITING

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xuening Li, Professor

  Zhongshan hospital affiliated to Fundan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Qiu, BS

CONTACT

+8617310793626; li.qiu@laekna.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: July 9, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)