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RECRUITING
NCT07660341
PHASE1

SAD Study of CGB3002 in Healthy Participants

Sponsor: ChainGen Biopharma Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2026-06-30

Completion Date

2027-04-30

Last Updated

2026-07-08

Healthy Volunteers

Yes

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.

Locations (1)

Nucleus Network

Melbourne, Victoria, Australia