Clinical Research Directory
Browse clinical research sites, groups, and studies.
SAD Study of CGB3002 in Healthy Participants
Sponsor: ChainGen Biopharma Ltd
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
Conditions
Interventions
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.
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.
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.
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.
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.
Placebo
Healthy participants will be administered a single intravenous dose of matching placebo.
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