RecruitingPhase 1NCT07660341

SAD Study of CGB3002 in Healthy Participants

A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Single Ascending Doses of CGB3002 in Healthy Participants

Sponsor

ChainGen Biopharma Ltd

Enrollment

46 participants

Start Date

Jun 30, 2026

Study Type

INTERVENTIONAL

Conditions

Alzheimer s Disease

Summary

This is a randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single ascending IV doses of CGB3002 in healthy participants. CGB3002 is being developed to treat Alzheimer's Disease.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CGB3002 0.08 mg/kg, a drug called CGB3002 0.4 mg/kg, and others for people with alzheimer s disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCGB3002 0.08 mg/kg

Cohorts 1: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 0.08 mg/kg.

DRUGCGB3002 0.4 mg/kg

Cohorts 2: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 0.4 mg/kg.

DRUGCGB3002 1.2 mg/kg

Cohorts 3: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 1.2 mg/kg.

DRUGCGB3002 3.6 mg/kg

Cohorts 4: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 3.6 mg/kg.

DRUGCGB3002 7.2 mg/kg

Cohorts 5: healthy participants will be administered a single intravenous dose of CGB3002 at dose level of 7.2 mg/kg.

DRUGPlacebo

Healthy participants will be administered a single intravenous dose of matching placebo.

DRUGComparator Drug

Healthy participants will receive a single intravenous dose of the comparator drug at the same dose level as CGB3002.

Locations(1)

Nucleus Network

Melbourne, Victoria, Australia

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NCT07660341

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