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SAD Study of CGB3002 in Healthy Participants

NCT07660341 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-07-08

No results posted yet for this study

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.

Conditions

  • Alzheimer s Disease

Interventions

DRUG

CGB3002 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.

DRUG

CGB3002 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.

DRUG

CGB3002 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.

DRUG

CGB3002 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.

DRUG

CGB3002 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.

DRUG

Placebo

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

DRUG

Comparator Drug

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

Sponsors & Collaborators

  • ChainGen Biopharma (Australia) Pty Ltd

    collaborator UNKNOWN

  • ChainGen Biopharma Ltd

    lead INDUSTRY

Principal Investigators

  • Zhizheng Zhang, M.D. · ChainGen Biopharma Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Australia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07660341 on ClinicalTrials.gov